Trial Outcomes & Findings for A Study of Trastuzumab Emtansine (T-DM1) Sequentially With Anthracycline-based Chemotherapy, as Adjuvant or Neoadjuvant Therapy for Patients With Early Stage Herceptin (HER)2-positive Breast Cancer (NCT NCT01196052)
NCT ID: NCT01196052
Last Updated: 2014-10-06
Results Overview
A cardiac event was defined as death from a cardiac cause or severe congestive failure (New York Heart Association \[NYHA\] Class III or IV) with a decrease in left ventricular ejection fraction (LVEF) of ≥ 10% from Baseline to an LVEF of \< 50%.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
153 participants
Primary outcome timeframe
Baseline to 12 weeks after the start of trastuzumab emtansine treatment
Results posted on
2014-10-06
Participant Flow
Participant milestones
| Measure |
Trastuzumab Emtansine
Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
|
|---|---|
|
Overall Study
STARTED
|
153
|
|
Overall Study
Received Trastuzumab Emtansine
|
148
|
|
Overall Study
COMPLETED
|
130
|
|
Overall Study
NOT COMPLETED
|
23
|
Reasons for withdrawal
| Measure |
Trastuzumab Emtansine
Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
|
|---|---|
|
Overall Study
Adverse Event
|
9
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Noncompliance to Protocol Requirements
|
2
|
|
Overall Study
Reason not Specified
|
5
|
|
Overall Study
Withdrawal by Subject
|
6
|
Baseline Characteristics
A Study of Trastuzumab Emtansine (T-DM1) Sequentially With Anthracycline-based Chemotherapy, as Adjuvant or Neoadjuvant Therapy for Patients With Early Stage Herceptin (HER)2-positive Breast Cancer
Baseline characteristics by cohort
| Measure |
Trastuzumab Emtansine
n=153 Participants
Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
|
|---|---|
|
Age, Continuous
|
51.1 years
STANDARD_DEVIATION 11.23 • n=5 Participants
|
|
Sex: Female, Male
Female
|
153 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 weeks after the start of trastuzumab emtansine treatmentPopulation: Cardiac-safety evaluable population: All participants who received at least 1 dose of T-DM1 and met either of the following 2 criteria: (1) Had an echocardiogram/multiple-gated acquisition assessment by 12 weeks after the first dose of T-DM1 or (2) discontinued study treatment because of cardiac toxicity prior to completion of 4 cycles of T-DM1.
A cardiac event was defined as death from a cardiac cause or severe congestive failure (New York Heart Association \[NYHA\] Class III or IV) with a decrease in left ventricular ejection fraction (LVEF) of ≥ 10% from Baseline to an LVEF of \< 50%.
Outcome measures
| Measure |
Trastuzumab Emtansine
n=143 Participants
Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
|
|---|---|
|
Percentage of Participants With a Cardiac Event Within 12 Weeks After the Start of Trastuzumab Emtansine Treatment
|
0 Percentage of participants
Interval 0.0 to 2.45
|
PRIMARY outcome
Timeframe: From the start to the end of trastuzumab emtansine treatment (up to 51 weeks)Population: Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine.
The following percentages of participants are reported: At least 1 adverse event while receiving T-DM1; at least 1 serious adverse event while receiving T-DM1; an adverse event leading to discontinuation, dose delay, or dose reduction of trastuzumab emtansine treatment; symptomatic cardiac dysfunction; and asymptomatic decline in left ventricular ejection fraction (LVEF). An asymptomatic LVEF decline was defined as a LVEF \< 50% and a maximum decrease ≥ 10% from Baseline. The percentage of participants who died is reported.
Outcome measures
| Measure |
Trastuzumab Emtansine
n=148 Participants
Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
|
|---|---|
|
Adverse Events, LVEF Function, and Deaths
An AE leading to treatment discontinuation
|
13.5 Percentage of participants
|
|
Adverse Events, LVEF Function, and Deaths
At least 1 adverse event (AE)
|
98.6 Percentage of participants
|
|
Adverse Events, LVEF Function, and Deaths
At least 1 serious adverse event
|
10.1 Percentage of participants
|
|
Adverse Events, LVEF Function, and Deaths
An AE leading to dose delay
|
29.1 Percentage of participants
|
|
Adverse Events, LVEF Function, and Deaths
An AE leading to dose reduction
|
21.6 Percentage of participants
|
|
Adverse Events, LVEF Function, and Deaths
Symptomatic cardiac dysfunction
|
0.0 Percentage of participants
|
|
Adverse Events, LVEF Function, and Deaths
An asymptomatic decline in LVEF
|
2.7 Percentage of participants
|
|
Adverse Events, LVEF Function, and Deaths
Deaths
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: From the start to the end of concurrent radiotherapy (up to 51 weeks)Population: Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. Only participants who received concurrent radiotherapy were included in the analysis.
Outcome measures
| Measure |
Trastuzumab Emtansine
n=39 Participants
Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
|
|---|---|
|
Percentage of Participants Who Experienced at Least 1 Adverse Event During Concurrent Radiotherapy With Trastuzumab Emtansine Treatment
|
94.9 Percentage of participants
|
SECONDARY outcome
Timeframe: From the start to the end of concurrent hormonal therapy (up to 51 weeks)Population: Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. Only participants who received concurrent hormonal therapy were included in the analysis.
Outcome measures
| Measure |
Trastuzumab Emtansine
n=62 Participants
Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
|
|---|---|
|
Percentage of Participants Who Experienced at Least 1 Adverse Event During Concurrent Hormonal Therapy With Trastuzumab Emtansine Treatment
|
69.4 Percentage of participants
|
SECONDARY outcome
Timeframe: From the start to the end of trastuzumab emtansine treatment (up to 51 weeks)Population: Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine.
Participants were to receive up to a total of 17 cycles of trastuzumab emtansine. If trastuzumab was given concurrently with either the optional docetaxel or optional radiation, then the number of 3-week cycles of trastuzumab therapy was subtracted from the planned 17 cycles of trastuzumab emtansine therapy.
Outcome measures
| Measure |
Trastuzumab Emtansine
n=148 Participants
Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
|
|---|---|
|
Percentage of Participants Who Completed the Planned Duration of Trastuzumab Emtansine Treatment
|
82.4 Percentage of participants
|
SECONDARY outcome
Timeframe: From the start to the end of radiotherapy treatment (up to 51 weeks)Population: Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. Only participants who received concurrent radiotherapy and who had radiotherapy dose information reported were included in the analysis.
Outcome measures
| Measure |
Trastuzumab Emtansine
n=38 Participants
Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
|
|---|---|
|
Percentage of Participants Who Completed ≥ 95% of the Planned Radiotherapy Treatment With Concurrent Trastuzumab Emtansine Administration Without Significant (> 5 Days) Delay
|
94.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Day of surgeryPopulation: Efficacy analysis population: All participants who enrolled in the neoadjuvant setting and received surgery, after completing 4 cycles of trastuzumab emtansine treatment.
Pathological complete response was defined as the absence of invasive neoplastic cells at microscopic examination of the primary tumor and lymph nodes after surgery following primary systemic therapy. Pathological complete response was evaluated in participants treated with neoadjuvant therapy doxorubicin/cyclophosphamide-5-fluorouracil/epirubicin/cyclophosphamide followed by 1 or more doses of trastuzumab emtansine and who underwent surgery.
Outcome measures
| Measure |
Trastuzumab Emtansine
n=50 Participants
Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
|
|---|---|
|
Percentage of Participants With a Pathological Complete Response
|
56.0 Percentage of participants
Interval 41.3 to 69.6
|
SECONDARY outcome
Timeframe: From the start of trastuzumab emtansine for adjuvant patients and from the date of surgery for neoadjuvant patients to 12 months laterPopulation: Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. Due to too few events, the analysis of disease-free survival was not performed.
Disease-free survival was defined as the time from date of first protocol treatment for adjuvant patients or date of surgery for neoadjuvant patients to disease recurrence, occurrence of invasive contralateral breast cancer, other second primary cancer (excluding non-breast second primary), or death, whichever occurred first.
Outcome measures
Outcome data not reported
Adverse Events
Trastuzumab Emtansine
Serious events: 15 serious events
Other events: 146 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Trastuzumab Emtansine
n=148 participants at risk
Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.68%
1/148 • Number of events 1
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
2/148 • Number of events 2
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.68%
1/148 • Number of events 1
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.68%
1/148 • Number of events 1
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
General disorders
Pyrexia
|
1.4%
2/148 • Number of events 2
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Infections and infestations
Cellulitis
|
0.68%
1/148 • Number of events 1
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Infections and infestations
Device related infection
|
1.4%
2/148 • Number of events 2
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Infections and infestations
Gastroenteritis viral
|
0.68%
1/148 • Number of events 1
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Infections and infestations
Gastrointestinal infection
|
0.68%
1/148 • Number of events 1
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.68%
1/148 • Number of events 1
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.68%
1/148 • Number of events 1
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.68%
1/148 • Number of events 1
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Investigations
Troponin increased
|
0.68%
1/148 • Number of events 1
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.68%
1/148 • Number of events 1
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
Other adverse events
| Measure |
Trastuzumab Emtansine
n=148 participants at risk
Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
|
|---|---|
|
General disorders
Asthenia
|
30.4%
45/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
General disorders
Fatigue
|
23.0%
34/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
General disorders
Pyrexia
|
26.4%
39/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
General disorders
Mucosal Inflammation
|
6.8%
10/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
General disorders
Influenza Like Illness
|
13.5%
20/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
General disorders
Chills
|
12.8%
19/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
General disorders
Oedema Peripheral
|
6.1%
9/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Gastrointestinal disorders
Nausea
|
37.8%
56/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Gastrointestinal disorders
Constipation
|
10.8%
16/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.2%
21/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Gastrointestinal disorders
Vomiting
|
16.9%
25/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Gastrointestinal disorders
Dry Mouth
|
13.5%
20/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Gastrointestinal disorders
Stomatitis
|
6.1%
9/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
10.8%
16/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.1%
12/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Gastrointestinal disorders
Abdominal Pain
|
9.5%
14/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
5.4%
8/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Gastrointestinal disorders
Gingival Bleeding
|
8.1%
12/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.1%
9/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
11.5%
17/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.2%
24/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.4%
11/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
6.1%
9/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Skin and subcutaneous tissue disorders
Nail Disorder
|
6.1%
9/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Nervous system disorders
Headache
|
37.2%
55/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Nervous system disorders
Dysgeusia
|
8.8%
13/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Nervous system disorders
Neuropathy Peripheral
|
12.2%
18/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
9.5%
14/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Nervous system disorders
Paraesthesia
|
6.8%
10/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Nervous system disorders
Dizziness
|
5.4%
8/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.9%
31/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.3%
33/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
11.5%
17/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
10.8%
16/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
10.8%
16/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
6.1%
9/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Infections and infestations
Nasopharyngitis
|
13.5%
20/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
10.1%
15/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Infections and infestations
Urinary Tract Infection
|
6.1%
9/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Infections and infestations
Sinusitis
|
5.4%
8/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
31.8%
47/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.2%
18/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.8%
10/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
6.1%
9/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.1%
15/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
21.6%
32/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Blood and lymphatic system disorders
Anaemia
|
8.8%
13/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Injury, poisoning and procedural complications
Radiation Skin Injury
|
8.1%
12/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Investigations
Aspartate Aminotransferase Increased
|
12.8%
19/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Investigations
Alanine Aminotransferase Increased
|
12.2%
18/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Eye disorders
Conjunctivitis
|
6.1%
9/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Eye disorders
Dry Eye
|
5.4%
8/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
12.2%
18/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.1%
9/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Vascular disorders
Hot Flush
|
13.5%
20/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Vascular disorders
Hypertension
|
5.4%
8/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Psychiatric disorders
Insomnia
|
8.1%
12/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Psychiatric disorders
Anxiety
|
6.1%
9/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Psychiatric disorders
Depression
|
7.4%
11/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Reproductive system and breast disorders
Breast Pain
|
6.8%
10/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
|
Ear and labyrinth disorders
Vertigo
|
5.4%
8/148
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
|
Additional Information
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