T-DM1 vs Paclitaxel/Trastuzumab for Breast (ATEMPT Trial) | NCT01853748

Status Module

Description Module

Brief Summary

This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different types of cancer. It also means that the FDA has not approved this drug for use patients undergoing adjuvant treatment for HER2+ breast cancer. Trastuzumab emtansine (T-DM1) is a drug that may stop cancer cells from growing. This drug has been used in other research studies and information from those other research studies suggests that this drug may help to prevent the recurrence of breast cancer in this research study.

The use of T-DM1 in this research study is experimental, which means it is not approved by any regulatory authority for the adjuvant treatment of HER2-positive breast cancer. However, it FDA-approved for metastatic HER2-positive breast cancer. T-DM1 has caused cancer cells to die in laboratory studies. In preclinical studies, this drug has prevented or slowed the growth of breast cancer. The breast cancer treatments (paclitaxel and Trastuzumab) used in this study are considered part of standard-of-care regimens in early breast cancer. A standard treatment means that this is a treatment that would be accepted by the majority of the medical community as a suitable treatment for your type of breast cancer.

In this research study, the investigators are looking to see if the study drug T-DM1 will have less side effects than traditional HER2-positive breast cancer treatment of trastuzumab and paclitaxel. The investigators are also hoping to learn about the long term benefits and disease-free survival of participants who take the study drug T-DM1 in comparison to those participants to take the combination of trastuzumab and paclitaxel.

Detailed Description

If a participant agrees to participate in this study she will be asked to undergo some screening tests or procedures to confirm that she is eligible. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if turns out that she does not take part in this research study. If she has had some of these tests or procedures recently, they may or may not have to be repeated. These tests and procedures will include: a medical history, performance status, assessment of your tumor, blood tests, cardiac tests, pregnancy test and a collection of tumor tissue. If these tests show that she is eligible to participate in the research study, she will begin the study treatment. If she does not meet the eligibility criteria, she will not be able to participate in this research study.

Because no one knows which of the study options is best, the participant will be "randomized" into one of the study groups after she has had her breast surgery: Group 1 or Group 2. Randomization means that she is put into a group by chance. Neither the participant nor the research doctor will choose what group she will be in. The participant will have a one in three chance of being placed in any group. Approximately 375 study participants will receive the study drug, while 125 study participants will receive the standard therapy of trastuzumab and paclitaxel.

Group 1 participants will receive the study drug T-DM1 every three weeks by IV (intravenous injection) for 17 treatments (total of 51 weeks).

Group 2 participants will receive the FDA-approved drugs Paclitaxel and Trastuzumab once per week by IV for 12 weeks. Then beginning week 13, participants will receive Trastuzumab only by IV injection every three weeks for the next 13 treatments.

During all cycles the participant will have a physical exam and tumor assessment.

The investigators would like to keep track of the participant's medical condition for the next five years after the final dose of study drug. The investigators would like to do this by regular visits every 6 months for 3 years after completion of study treatment, and then once a year for the next two years. The investigators may ask for additional follow-up by phone after completion of these visits.

Participants who undergo lumpectomy (breast conserving surgery) need to receive breast radiation therapy to participate in this study. Participants who have undergone a mastectomy may receive chest wall and lymph node radiation (as determined by discussion with their physician). Radiation Therapy will begin after the conclusion of all study paclitaxel doses, and after 12 weeks fo the study drug T-DM1.

Label	Type	Description	Intervention Names
Trastuzumab emtansine (T-DM1)	Active Comparator	T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks	Drug: Trastuzumab emtansine
Paclitaxel + Trastuzumab	Active Comparator	paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments	Drug: Trastuzumab Drug: Paclitaxel

Name	Type	Description	Arm Group Labels	Other Names
Trastuzumab	Drug		Paclitaxel + Trastuzumab
Paclitaxel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants of Clinically Relevant Toxicities (CRT)	Clinically relevant toxicities will include the composite incidence of grade 3 or higher non-hematologic toxicity, grade 2 or higher neurotoxicity, and grade 4 or higher hematologic toxicity. These toxicities will only be assessed at the pre-specified toxicity-assessment visits. In addition, the following events, regardless of timing of their occurrence, will also count towards the composite endpoint: febrile neutropenia, any toxicity requiring dose-delay, discontinuation of any study treatment (Paclitaxel, Trastuzumab, or T-DM1) for toxicity, and any serious adverse event (SAE).	5 years after completion of study treatment or until death, whichever occurs first.
3-year Disease Free Survival (DFS) Rate of Trastuzumab Emtansine (TDM-1)	Disease-free survival (DFS) is evaluated and defined per protocol: from the time of randomization until the to the occurrence of the first of the following events: Local/regional recurrence: a recurrent or new invasive ipsilateral breast cancer, invasive breast cancer in the axilla, regional lymph nodes, chest wall, or skin of the ipsilateral breast. Contralateral invasive breast cancer, Distant recurrence: metastatic disease that has either been biopsy confirmed or clinically diagnosed as recurrent invasive breast cancer. A single new lesion on a bone scan without evidence of lytic disease on x-ray and without symptoms does not in and of itself constitute distant recurrence, but multiple new bone lesions, or increased isotope uptake associated with new bone symptoms are more likely due to metastases. Bone metastases must be documented with x-rays and clinical description. Death from any cause	3 years

Secondary Outcomes

Measure	Description	Time Frame
Incidence Rate of Grade 3-4 Treatment-Related Toxicity	All grade 3 - 4 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4 as reported on case report forms were counted. Incidence is the number of patients experiencing at least one treatment-related grade >=3 AE of any type during the time of observation.	AE is reported every 3 weeks for the first 12 weeks, then every 9 weeks for the subsequent 39 weeks, then follow-up up to 5 years after completion of study treatment or until death, whichever occurs first. Median follow-up 3.1 years.

Eligibility Module

Name	Affiliation	Role
Sara Tolaney, MD, MPH	Dana-Farber Cancer Institute	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama Birmingham		Birmingham	Alabama	35249	United States
University of California San Francisco

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38935923	Derived	Tarantino P, Tayob N, Villacampa G, Dang C, Yardley DA, Isakoff SJ, Valero V, Faggen M, Mulvey T, Bose R, Weckstein D, Wolff AC, Reeder-Hayes K, Rugo HS, Ramaswamy B, Zuckerman D, Hart L, Gadi VK, Constantine M, Cheng K, Garrett AM, Marcom PK, Albain K, DeFusco P, Tung N, Ardman B, Nanda R, Jankowitz RC, Rimawi M, Abramson V, Pohlmann PR, Van Poznak C, Forero-Torres A, Liu MC, Ruddy KJ, Waks AG, DeMeo M, Burstein HJ, Partridge AH, Dell'Orto P, Russo L, Krause E, Newhouse DJ, Kurt BB, Mittendorf EA, Schneider B, Prat A, Winer EP, Krop IE, Tolaney SM; Consortium of the TBCRC Translational Investigators; TBCRC Translational Investigators. Adjuvant Trastuzumab Emtansine Versus Paclitaxel Plus Trastuzumab for Stage I Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: 5-Year Results and Correlative Analyses From ATEMPT. J Clin Oncol. 2024 Nov;42(31):3652-3665. doi: 10.1200/JCO.23.02170. Epub 2024 Jun 27.
36450763

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Trastuzumab Emtansine (T-DM1)	T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
FG001	Paclitaxel + Trastuzumab (TH)	paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Sep 1, 2017

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants of Clinically Relevant Toxicities (CRT)

Clinically relevant toxicities will include the composite incidence of grade 3 or higher non-hematologic toxicity, grade 2 or higher neurotoxicity, and grade 4 or higher hematologic toxicity. These toxicities will only be assessed at the pre-specified toxicity-assessment visits. In addition, the following events, regardless of timing of their occurrence, will also count towards the composite endpoint: febrile neutropenia, any toxicity requiring dose-delay, discontinuation of any study treatment (Paclitaxel, Trastuzumab, or T-DM1) for toxicity, and any serious adverse event (SAE).

Posted

Count of Participants

Participants

5 years after completion of study treatment or until death, whichever occurs first.

ID	Title	Description
OG000	Trastuzumab Emtansine (T-DM1)	T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
OG001	Paclitaxel + Trastuzumab	paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments

Units	Counts
Participants	OG000383 OG001114

Title

Denominators

Categories

Grade 3 or higher non-hematologic toxicity

Title	Measurements
	OG00036 OG00113

Grade 2 or higher neurotoxicity

Title	Measurements
	OG000

Primary

3-year Disease Free Survival (DFS) Rate of Trastuzumab Emtansine (TDM-1)

Disease-free survival (DFS) is evaluated and defined per protocol: from the time of randomization until the to the occurrence of the first of the following events:

Local/regional recurrence: a recurrent or new invasive ipsilateral breast cancer, invasive breast cancer in the axilla, regional lymph nodes, chest wall, or skin of the ipsilateral breast.
Contralateral invasive breast cancer,
Distant recurrence: metastatic disease that has either been biopsy confirmed or clinically diagnosed as recurrent invasive breast cancer. A single new lesion on a bone scan without evidence of lytic disease on x-ray and without symptoms does not in and of itself constitute distant recurrence, but multiple new bone lesions, or increased isotope uptake associated with new bone symptoms are more likely due to metastases. Bone metastases must be documented with x-rays and clinical description.
Death from any cause

Posted

Number

95% Confidence Interval

proportion of participants

3 years

ID	Title	Description
OG000	Trastuzumab Emtansine (T-DM1)	T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
OG001	Paclitaxel + Trastuzumab	paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments

Secondary

Incidence Rate of Grade 3-4 Treatment-Related Toxicity

All grade 3 - 4 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4 as reported on case report forms were counted. Incidence is the number of patients experiencing at least one treatment-related grade >=3 AE of any type during the time of observation.

Posted

Number

95% Confidence Interval

proportion of participants

AE is reported every 3 weeks for the first 12 weeks, then every 9 weeks for the subsequent 39 weeks, then follow-up up to 5 years after completion of study treatment or until death, whichever occurs first. Median follow-up 3.1 years.

ID	Title	Description
OG000	Trastuzumab Emtansine (T-DM1)	T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
OG001	Paclitaxel + Trastuzumab	paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments

Units	Counts
Participants

Secondary

Quality of Life (QOL) FACT B Total Score at Baseline

The QOL assessments questionnaire should be completed via the tablet provided by the study or on any available computer with an internet connection. The FACT-B questionnaire consists of five subscale, listed below:

Physical well being(PWB): range 0-28 Social/Family well being(SWB): range 0-28 Emotional well being(EWB): range 0-24 Functional well being(FWB): range 0-28 Breast cancer subscale(BCS): range 0-40 The total score (FACTB) is calculated by summarizing all the subscales listed above, therefore it ranges from 0 to 148. The higher the score the better the outcome (applies to all sub-scales as well).

Posted

Mean

Standard Deviation

score on a scale

at baseline

ID	Title	Description
OG000	Trastuzumab Emtansine (T-DM1)	T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
OG001	Paclitaxel + Trastuzumab (TH)	paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments

Units	Counts
Participants

Secondary

Quality of Life (QOL) FACT B Total Score at Week 3

not all patients required to complete the QOL

Posted

Mean

Standard Deviation

score on a scale

at week 3

ID	Title	Description
OG000	Trastuzumab Emtansine (T-DM1)	T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
OG001	Paclitaxel + Trastuzumab	paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments

Units	Counts

Secondary

Quality of Life (QOL) FACT B Total Score at Week 12

not all patients required to complete the QOL

Posted

Mean

Standard Deviation

score on a scale

at week 12

ID	Title	Description
OG000	Trastuzumab Emtansine (T-DM1)	T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
OG001	Paclitaxel + Trastuzumab	paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments

Units	Counts

Secondary

Quality of Life (QOL) FACT B Total Score at 6 Months

not all patients required to complete the QOL

Posted

Mean

Standard Deviation

score on a scale

at 6 months

ID	Title	Description
OG000	Trastuzumab Emtansine (T-DM1)	T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
OG001	Paclitaxel + Trastuzumab	paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments

Units	Counts

Secondary

Quality of Life (QOL) FACT B Total Score at 1 Year

not all patients required to complete the QOL

Posted

Mean

Standard Deviation

score on a scale

at 1 year

ID	Title	Description
OG000	Trastuzumab Emtansine (T-DM1)	T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
OG001	Paclitaxel + Trastuzumab	paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments

Units	Counts

Secondary

Quality of Life (QOL) FACT B Total Score at 18 Months

not all patients required to complete the QOL

Posted

Mean

Standard Deviation

score on a scale

at 18 months

ID	Title	Description
OG000	Trastuzumab Emtansine (T-DM1)	T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
OG001	Paclitaxel + Trastuzumab	paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments

Units	Counts

Secondary

Quality of Life (QOL) FACT B Total Score at 24 Months

not all patients required to complete the QOL

Posted

Mean

Standard Deviation

score on a scale

at 24 months

ID	Title	Description
OG000	Trastuzumab Emtansine (T-DM1)	T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
OG001	Paclitaxel + Trastuzumab	paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments

Units	Counts

Secondary

Number of Patients Has Neuropathy

Neuropathy evaluated by Patient Neurotoxicity Questionnaire (PNQ) defined per protocol.

The PNQ analysis was done on patients that completed at least baseline questionnaires and at least one follow-up questionnaire. Some patients did not complete this questionnaire at either baseline or follow-up. This is the reason for the reduced number of patients when reporting PNQ results.

Posted

Count of Participants

Participants

Surveys are took at week 3, 12 and month 6 and 12 during treatment, and month 18. The data cutoff date is 18 month.

ID	Title	Description
OG000	T-DM1 With no Baseline Neuropathy	T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks. No neuropathy at baseline
OG001	TH With no Baseline Neuropathy	paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments. No neuropathy at baseline
OG002	T-DM1 With Any Baseline Neuropathy	T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks. Neuropathy at baseline

Secondary

Percentage of Work Time Missed Because of Health

Effects of therapy on work productivity and activity - work time missed because of health, evaluated using the Work Productivity and Activity Impairment Questionnaire (WPAI-SHP), which defined per protocol.

Posted

Mean

Standard Deviation

percentage of time

Surveys are took at week 3, 12 and month 6 and 12 during treatment, and month 18, 24, 30 and 36 during follow up.

ID	Title	Description
OG000	Trastuzumab Emtansine (T-DM1)	T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
OG001	Paclitaxel + Trastuzumab	paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments

Units	Counts
Participants	OG000

Secondary

Percentage of Impairment While Working Because of Health (Mean, SD)

Effects of therapy on work productivity and activity - Impairment While Working because of health, evaluated using the Work Productivity and Activity Impairment Questionnaire (WPAI-SHP), which defined per protocol.

Posted

Mean

Standard Deviation

percentage of time

Surveys are took at week 3, 12 and month 6 and 12 during treatment, and month 18, 24, 30 and 36 during follow up.

ID	Title	Description
OG000	Trastuzumab Emtansine (T-DM1)	T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks Trastuzumab emtansine
OG001	Paclitaxel + Trastuzumab	paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments Trastuzumab Paclitaxel

Units	Counts
Participants	OG000

Secondary

Percentage of Overall Work Impairment Because of Health

Effects of therapy on work productivity and activity - Work Impairment because of health, evaluated using the Work Productivity and Activity Impairment Questionnaire (WPAI-SHP), which defined per protocol.

Posted

Mean

Standard Deviation

percentage of time

Surveys are took at week 3, 12 and month 6 and 12 during treatment, and month 18, 24, 30 and 36 during follow up.

ID	Title	Description
OG000	Trastuzumab Emtansine (T-DM1)	T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
OG001	Paclitaxel + Trastuzumab (TH)	paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments

Units	Counts
Participants	OG000

Secondary

Percentage of Activity Impairment Because of Health

Effects of therapy on work productivity and activity - Activity Impairment because of health, evaluated using the Work Productivity and Activity Impairment Questionnaire (WPAI-SHP), which defined per protocol.

Posted

Mean

Standard Deviation

percentage of time

Surveys are took at week 3, 12 and month 6 and 12 during treatment, and month 18, 24, 30 and 36 during follow up.

ID	Title	Description
OG000	Trastuzumab Emtansine (T-DM1)	T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
OG001	Paclitaxel + Trastuzumab (TH)	paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments

Units	Counts
Participants	OG000

Secondary

Number of Patients Have Alopecia

alopecia assessment is a 5-item questionnaire that will assess the impact alopecia has had on these patients and will be conducted electronically at pre-specified study visits. If electronic evaluation is not possible, paper evaluation will be conducted.

Posted

Count of Participants

Participants

Median follow-up was 3.9 years. The AE data cutoff date is 21 April 2020.

ID	Title	Description
OG000	Trastuzumab Emtansine (T-DM1)	T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
OG001	Paclitaxel + Trastuzumab	paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments

Units	Counts
Participants	OG000

Secondary

3-year T-DM1 iDFS Percentage by Tumor Size and Hormone Receptor (HR) Status

Disease-free survival (DFS) is evaluated in patients treated with trastuzumab emtansine, which is defined per protocol: from the time of randomization until the to the occurrence of the first of the following events:

Local/regional recurrence: a recurrent or new invasive ipsilateral breast cancer, invasive breast cancer in the axilla, regional lymph nodes, chest wall, or skin of the ipsilateral breast.
Contralateral invasive breast cancer,
Distant recurrence: metastatic disease that has either been biopsy confirmed or clinically diagnosed as recurrent invasive breast cancer. A single new lesion on a bone scan without evidence of lytic disease on x-ray and without symptoms does not in and of itself constitute distant recurrence, but multiple new bone lesions, or increased isotope uptake associated with new bone symptoms are more likely due to metastases. Bone metastases must be documented with x-rays and clinical description.
Death from any cause

Posted

Number

95% Confidence Interval

percentage of participants

3 years

ID	Title	Description
OG000	Trastuzumab Emtansine (T-DM1) With Tumor Size < 1 cm	T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
OG001	Trastuzumab Emtansine (T-DM1) With Tumor Size >= 1 cm	T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks

Secondary

Number of Incidence of Grade 3-4 Cardiac Left Ventricular Dysfunction

Posted

Count of Participants

Participants

ID	Title	Description
OG000	Trastuzumab Emtansine (T-DM1)	T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
OG001	Paclitaxel + Trastuzumab (TH)	paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments

Units	Counts
Participants

Secondary

Number of Incidence of T-DM1 Induced Grade 2-3 Thrombocytopenia

Reversible Grade 1-4 thrombocytopenia has been observed in ongoing studies with trastuzumab emtansine.

Posted

Count of Participants

Participants

ID	Title	Description
OG000	Trastuzumab Emtansine (T-DM1)	T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
OG001	Paclitaxel + Trastuzumab	paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments

Units	Counts
Participants	OG000

Secondary

Number of SNPs With Top Associations of Trastuzumab Emtansine-induced Grade 2-4 Thrombocytopenia in the T-DM1 Arm

DNA will be genotyped for SNPs and CNV markers using the Infinium Human Omni1 array (1.2 million SNP platform) from Illumina. A gene-based association analyses for thrombocytopenia or bleeding is applied with significancy (p-value). This analysis was only conducted in the T-DM1 arm.

Posted

Number

number of SNPs

DNA sample collected at pre-treatment. AE is reported every 3 weeks for the first 12 weeks, then every 9 weeks for the subsequent 39 weeks.

ID	Title	Description
OG000	Trastuzumab Emtansine (T-DM1)	T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks

Units	Counts
Participants	OG000

Secondary

Percentage of Patients With Amenorrhea

For those who were premenopausal pre-chemotherapy, at each follow-up visit (every six months) in order to assess for duration of amenorrhea and also premature ovarian failure.

Posted

Number

percentage of participants

Surveys are took at month 6 and 12 during treatment, and month 18, 24, 30 and 36 during follow up.

ID	Title	Description
OG000	Trastuzumab Emtansine (T-DM1)	T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
OG001	Paclitaxel + Trastuzumab (TH)	paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments

Units	Counts
Participants

Secondary

Gene Mutation Assessed Using High-throughput Mutation Profiling System (Oncomap)

Archival tumor tissue from all patients will be assessed using a high-throughput mutation profiling system (Oncomap) to query a large panel of cancer gene mutations.

no genomic data were collected using the Oncomap system

Posted

After treatment

ID	Title	Description
OG000	Trastuzumab Emtansine (T-DM1)	T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
OG001	Paclitaxel + Trastuzumab (TH)	paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments

Units	Counts
Participants	OG000

Secondary

Median Overall Survival (OS)

OS is evaluated in patients with Stage I HER2-positive breast cancer treated with trastuzumab emtansine

Posted

Number

95% Confidence Interval

months

Reported every 3 weeks for the first 12 weeks, then every 9 weeks for the subsequent 39 weeks, then follow-up up to 5 years after completion of study treatment or until death, whichever occurs first.

ID	Title	Description
OG000	Trastuzumab Emtansine (T-DM1)	T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
OG001	Paclitaxel + Trastuzumab (TH)	paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected383 at risk EG0010 affected114 at risk
Febrile neutropenia	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected383 at risk EG0012 affected114 at risk
Leukocytosis	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Left ventricular systolic dysfunction	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Fatigue	General disorders and administration site conditions	CTCAE (4.0)	Systematic Assessment	EG0003 affected383 at risk EG0012 affected114 at risk
Infusion related reaction	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0012 affected114 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Constipation	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Diarrhea	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0013 affected114 at risk
Dyspepsia	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Gastric hemorrhage	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Nausea	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected383 at risk EG0010 affected114 at risk
Oral hemorrhage	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Vomiting	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0011 affected114 at risk
Cholecystitis	Hepatobiliary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Gum infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Skin infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Wound infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Alanine aminotransferase increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0011 affected114 at risk
CPK increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Ejection fraction decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected383 at risk EG0011 affected114 at risk
Lipase increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Neutrophil count decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0003 affected383 at risk EG0017 affected114 at risk
Platelet count decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG00012 affected383 at risk EG0010 affected114 at risk
Weight loss	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
White blood cell decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0011 affected114 at risk
Dehydration	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Hypernatremia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected383 at risk EG0011 affected114 at risk
Hypokalemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Myalgia	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Headache	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Paresthesia	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0010 affected114 at risk
Peripheral motor neuropathy	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected383 at risk EG0014 affected114 at risk
Peripheral sensory neuropathy	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0009 affected383 at risk EG0016 affected114 at risk
Cough	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0010 affected114 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Hematuria	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Irregular menstruation	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected383 at risk EG0011 affected114 at risk
Menorrhagia	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Premature menopause	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Vaginal hemorrhage	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Hot flashes	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Hypertension	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0008 affected383 at risk EG0012 affected114 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Ear pain	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected383 at risk EG0010 affected114 at risk
Hearing impaired	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG0006 affected383 at risk EG0010 affected114 at risk
Tinnitus	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected383 at risk EG0010 affected114 at risk
Tinnitus	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Vertigo	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected383 at risk EG0011 affected114 at risk
Vestibular disorder	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Ear and labyrinth disorders - Other	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Anemia	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG00053 affected383 at risk EG00126 affected114 at risk
Febrile neutropenia	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected383 at risk EG0011 affected114 at risk
Leukocytosis	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Lymph node pain	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0010 affected114 at risk
Thrombotic thrombocytopenic purpura	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected383 at risk EG0010 affected114 at risk
Blood and lymphatic system disorders - Other	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0009 affected383 at risk EG0012 affected114 at risk
Atrial fibrillation	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected383 at risk EG0011 affected114 at risk
Chest pain - cardiac	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0011 affected114 at risk
Left ventricular systolic dysfunction	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Palpitations	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG00014 affected383 at risk EG0013 affected114 at risk
Pericardial effusion	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0011 affected114 at risk
Restrictive cardiomyopathy	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected383 at risk EG0011 affected114 at risk
Sinus bradycardia	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0013 affected114 at risk
Sinus tachycardia	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected383 at risk EG0011 affected114 at risk
Supraventricular tachycardia	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Ventricular arrhythmia	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected383 at risk EG0011 affected114 at risk
Ventricular tachycardia	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Cardiac disorders - Other	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected383 at risk EG0011 affected114 at risk
Chills	General disorders and administration site conditions	CTCAE (4.0)	Systematic Assessment	EG00029 affected383 at risk EG0013 affected114 at risk
Edema face	General disorders and administration site conditions	CTCAE (4.0)	Systematic Assessment	EG0004 affected383 at risk EG0013 affected114 at risk
Edema limbs	General disorders and administration site conditions	CTCAE (4.0)	Systematic Assessment	EG00035 affected383 at risk EG00119 affected114 at risk
Edema trunk	General disorders and administration site conditions	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0011 affected114 at risk
Facial pain	General disorders and administration site conditions	CTCAE (4.0)	Systematic Assessment	EG0003 affected383 at risk EG0010 affected114 at risk
Fatigue	General disorders and administration site conditions	CTCAE (4.0)	Systematic Assessment	EG000250 affected383 at risk EG00180 affected114 at risk
Fever	General disorders and administration site conditions	CTCAE (4.0)	Systematic Assessment	EG00039 affected383 at risk EG0019 affected114 at risk
Flu like symptoms	General disorders and administration site conditions	CTCAE (4.0)	Systematic Assessment	EG00024 affected383 at risk EG0015 affected114 at risk
Gait disturbance	General disorders and administration site conditions	CTCAE (4.0)	Systematic Assessment	EG0000 affected383 at risk EG0012 affected114 at risk
Infusion related reaction	General disorders	CTCAE (4.0)	Systematic Assessment	EG00023 affected383 at risk EG00111 affected114 at risk
Injection site reaction	General disorders and administration site conditions	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Irritability	General disorders and administration site conditions	CTCAE (4.0)	Systematic Assessment	EG0003 affected383 at risk EG0012 affected114 at risk
Localized edema	General disorders and administration site conditions	CTCAE (4.0)	Systematic Assessment	EG00011 affected383 at risk EG0014 affected114 at risk
Non-cardiac chest pain	General disorders and administration site conditions	CTCAE (4.0)	Systematic Assessment	EG00012 affected383 at risk EG0012 affected114 at risk
Pain	General disorders and administration site conditions	CTCAE (4.0)	Systematic Assessment	EG00046 affected383 at risk EG00123 affected114 at risk
General disorders and administration site conditions - Other	General disorders and administration site conditions	CTCAE (4.0)	Systematic Assessment	EG00017 affected383 at risk EG0019 affected114 at risk
Alopecia	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00021 affected383 at risk EG00164 affected114 at risk
Bullous dermatitis	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Dry skin	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00029 affected383 at risk EG00115 affected114 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected383 at risk EG0010 affected114 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected383 at risk EG0010 affected114 at risk
Erythroderma	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected383 at risk EG0010 affected114 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected383 at risk EG0012 affected114 at risk
Hypohidrosis	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Nail discoloration	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected383 at risk EG00114 affected114 at risk
Nail loss	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected383 at risk EG0015 affected114 at risk
Nail ridging	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0006 affected383 at risk EG0013 affected114 at risk
Pain of skin	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0012 affected114 at risk
Palmar-plantar erythrodysesthesia syndrome	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected383 at risk EG0012 affected114 at risk
Periorbital edema	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Photosensitivity	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0011 affected114 at risk
Pruritus	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00018 affected383 at risk EG00110 affected114 at risk
Rash acneiform	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00030 affected383 at risk EG00116 affected114 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00039 affected383 at risk EG00117 affected114 at risk
Scalp pain	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0014 affected114 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00010 affected383 at risk EG0013 affected114 at risk
Skin ulceration	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0011 affected114 at risk
Telangiectasia	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected383 at risk EG0011 affected114 at risk
Urticaria	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0011 affected114 at risk
Skin and subcutaneous tissue disorders - Other	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00053 affected383 at risk EG00120 affected114 at risk
Hyperthyroidism	Endocrine disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Hypothyroidism	Endocrine disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0010 affected114 at risk
Endocrine disorders - Other	Endocrine disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0010 affected114 at risk
Abdominal distension	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0010 affected114 at risk
Abdominal pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG00030 affected383 at risk EG0017 affected114 at risk
Bloating	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0007 affected383 at risk EG0014 affected114 at risk
Cecal hemorrhage	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Colitis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0011 affected114 at risk
Colonic ulcer	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected383 at risk EG0011 affected114 at risk
Constipation	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG000111 affected383 at risk EG00112 affected114 at risk
Dental caries	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Diarrhea	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG00063 affected383 at risk EG00154 affected114 at risk
Dry mouth	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG000118 affected383 at risk EG0016 affected114 at risk
Duodenal hemorrhage	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0010 affected114 at risk
Duodenal ulcer	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Dyspepsia	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG00047 affected383 at risk EG00115 affected114 at risk
Dysphagia	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0011 affected114 at risk
Esophagitis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0010 affected114 at risk
Flatulence	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0006 affected383 at risk EG0010 affected114 at risk
Gastritis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0010 affected114 at risk
Gastroesophageal reflux disease	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG00047 affected383 at risk EG00118 affected114 at risk
Gastrointestinal pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected383 at risk EG0012 affected114 at risk
Gingival pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected383 at risk EG0011 affected114 at risk
Hemorrhoidal hemorrhage	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Hemorrhoids	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0006 affected383 at risk EG0012 affected114 at risk
Mucositis oral	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG00048 affected383 at risk EG00115 affected114 at risk
Nausea	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG000192 affected383 at risk EG00146 affected114 at risk
Oral dysesthesia	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected383 at risk EG0012 affected114 at risk
Oral hemorrhage	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0007 affected383 at risk EG0010 affected114 at risk
Oral pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0013 affected114 at risk
Periodontal disease	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected383 at risk EG0011 affected114 at risk
Rectal hemorrhage	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0008 affected383 at risk EG0012 affected114 at risk
Stomach pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected383 at risk EG0011 affected114 at risk
Tooth development disorder	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Tooth discoloration	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected383 at risk EG0011 affected114 at risk
Toothache	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected383 at risk EG0011 affected114 at risk
Vomiting	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG00038 affected383 at risk EG00113 affected114 at risk
Gastrointestinal disorders - Other	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG00019 affected383 at risk EG0015 affected114 at risk
Hepatic pain	Hepatobiliary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Hepatobiliary disorders - Other	Hepatobiliary disorders	CTCAE (4.0)	Systematic Assessment	EG0007 affected383 at risk EG0011 affected114 at risk
Allergic reaction	Immune system disorders	CTCAE (4.0)	Systematic Assessment	EG0009 affected383 at risk EG0011 affected114 at risk
Cytokine release syndrome	Immune system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Immune system disorders - Other	Immune system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Appendicitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Bladder infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Breast infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0005 affected383 at risk EG0012 affected114 at risk
Bronchial infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0011 affected114 at risk
Catheter related infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0011 affected114 at risk
Conjunctivitis infective	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0010 affected114 at risk
Esophageal infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Eye infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0012 affected114 at risk
Gum infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Laryngitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Laryngitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0010 affected114 at risk
Lip infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Lip infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0010 affected114 at risk
Lung infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0005 affected383 at risk EG0011 affected114 at risk
Mucosal infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0011 affected114 at risk
Nail infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0011 affected114 at risk
Otitis externa	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0003 affected383 at risk EG0010 affected114 at risk
Otitis media	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0007 affected383 at risk EG0011 affected114 at risk
Papulopustular rash	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0007 affected383 at risk EG0015 affected114 at risk
Paronychia	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0003 affected383 at risk EG0010 affected114 at risk
Pharyngitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0011 affected114 at risk
Phlebitis infective	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected383 at risk EG0011 affected114 at risk
Rash pustular	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Rhinitis infective	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0004 affected383 at risk EG0010 affected114 at risk
Rhinitis infective	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Sepsis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected383 at risk EG0011 affected114 at risk
Sinusitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG00015 affected383 at risk EG0011 affected114 at risk
Sinusitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG00015 affected383 at risk EG0013 affected114 at risk
Skin infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0004 affected383 at risk EG0012 affected114 at risk
Skin infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG00012 affected383 at risk EG0017 affected114 at risk
Soft tissue infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Stoma site infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Tooth infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0004 affected383 at risk EG0012 affected114 at risk
Upper respiratory infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG00013 affected383 at risk EG0012 affected114 at risk
Upper respiratory infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG00028 affected383 at risk EG0019 affected114 at risk
Urinary tract infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0013 affected114 at risk
Urinary tract infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG00034 affected383 at risk EG0013 affected114 at risk
Vaginal infection	Immune system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0011 affected114 at risk
Vaginal infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0006 affected383 at risk EG0012 affected114 at risk
Wound infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0010 affected114 at risk
Infections and infestations - Other	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG00013 affected383 at risk EG00110 affected114 at risk
Ankle fracture	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Bruising	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG00015 affected383 at risk EG0010 affected114 at risk
Burn	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0005 affected383 at risk EG0011 affected114 at risk
Dermatitis radiation	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG00044 affected383 at risk EG00113 affected114 at risk
Fall	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0005 affected383 at risk EG0015 affected114 at risk
Fracture	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0013 affected114 at risk
Intraoperative breast injury	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected383 at risk EG0011 affected114 at risk
Intraoperative skin injury	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected383 at risk EG0011 affected114 at risk
Radiation recall reaction (dermatologic)	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Seroma	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0003 affected383 at risk EG0011 affected114 at risk
Spinal fracture	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Vascular access complication	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Wound complication	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0011 affected114 at risk
Wrist fracture	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Injury, poisoning and procedural complications - Other, specify	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0005 affected383 at risk EG0011 affected114 at risk
Alanine aminotransferase increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG000111 affected383 at risk EG00118 affected114 at risk
Alkaline phosphatase increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG00057 affected383 at risk EG0012 affected114 at risk
Aspartate aminotransferase increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG000129 affected383 at risk EG0019 affected114 at risk
Blood bilirubin increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG00038 affected383 at risk EG0014 affected114 at risk
Creatinine increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0004 affected383 at risk EG0015 affected114 at risk
Ejection fraction decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0003 affected383 at risk EG0012 affected114 at risk
Lipase increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0010 affected114 at risk
Lymphocyte count decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG00014 affected383 at risk EG0014 affected114 at risk
Lymphocyte count increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Neutrophil count decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG00024 affected383 at risk EG00118 affected114 at risk
Platelet count decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG00089 affected383 at risk EG0015 affected114 at risk
Weight gain	Investigations	CTCAE (4.0)	Systematic Assessment	EG0008 affected383 at risk EG0016 affected114 at risk
Weight loss	Investigations	CTCAE (4.0)	Systematic Assessment	EG00028 affected383 at risk EG0016 affected114 at risk
White blood cell decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG00024 affected383 at risk EG00114 affected114 at risk
Investigations - Other, specify	Investigations	CTCAE (4.0)	Systematic Assessment	EG0009 affected383 at risk EG0013 affected114 at risk
Anorexia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG00058 affected383 at risk EG00114 affected114 at risk
Dehydration	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG00010 affected383 at risk EG0014 affected114 at risk
Glucose intolerance	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected383 at risk EG0010 affected114 at risk
Hypercalcemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0009 affected383 at risk EG0010 affected114 at risk
Hyperglycemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG00028 affected383 at risk EG0016 affected114 at risk
Hyperkalemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0005 affected383 at risk EG0011 affected114 at risk
Hypernatremia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected383 at risk EG0012 affected114 at risk
Hypertriglyceridemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Hypoalbuminemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG00019 affected383 at risk EG0015 affected114 at risk
Hypocalcemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected383 at risk EG0015 affected114 at risk
Hypoglycemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0009 affected383 at risk EG0011 affected114 at risk
Hypokalemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0014 affected114 at risk
Hypokalemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG00032 affected383 at risk EG0014 affected114 at risk
Hypomagnesemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0011 affected114 at risk
Hyponatremia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG00011 affected383 at risk EG0014 affected114 at risk
Hypophosphatemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Metabolism and nutrition disorders - Other	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected383 at risk EG0010 affected114 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00094 affected383 at risk EG00128 affected114 at risk
Arthritis	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0007 affected383 at risk EG0013 affected114 at risk
Back pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00029 affected383 at risk EG00112 affected114 at risk
Bone pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00013 affected383 at risk EG0016 affected114 at risk
Chest wall pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0005 affected383 at risk EG0013 affected114 at risk
Fibrosis deep connective tissue	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Flank pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0005 affected383 at risk EG0011 affected114 at risk
Generalized muscle weakness	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0009 affected383 at risk EG0016 affected114 at risk
Growth suppression	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0008 affected383 at risk EG0011 affected114 at risk
Muscle weakness lower limb	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0012 affected114 at risk
Muscle weakness upper limb	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0010 affected114 at risk
Myalgia	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00075 affected383 at risk EG00115 affected114 at risk
Neck pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00011 affected383 at risk EG0010 affected114 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0006 affected383 at risk EG0011 affected114 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00034 affected383 at risk EG00114 affected114 at risk
Superficial soft tissue fibrosis	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0011 affected114 at risk
Musculoskeletal and connective tissue disorder - Other, specify	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00029 affected383 at risk EG0015 affected114 at risk
Akathisia	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0012 affected114 at risk
Amnesia	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Ataxia	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Cognitive disturbance	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected383 at risk EG0011 affected114 at risk
Concentration impairment	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected383 at risk EG0011 affected114 at risk
Dizziness	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG00028 affected383 at risk EG00115 affected114 at risk
Dysgeusia	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG00055 affected383 at risk EG00111 affected114 at risk
Dysphasia	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected383 at risk EG0011 affected114 at risk
Extrapyramidal disorder	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Headache	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG000118 affected383 at risk EG00133 affected114 at risk
Hypersomnia	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0010 affected114 at risk
Lethargy	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Leukoencephalopathy	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected383 at risk EG0011 affected114 at risk
Memory impairment	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0008 affected383 at risk EG0014 affected114 at risk
Paresthesia	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG00028 affected383 at risk EG0017 affected114 at risk
Peripheral motor neuropathy	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG00023 affected383 at risk EG00117 affected114 at risk
Peripheral sensory neuropathy	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG000119 affected383 at risk EG00150 affected114 at risk
Presyncope	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected383 at risk EG0011 affected114 at risk
Sinus pain	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0011 affected114 at risk
Spasticity	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0011 affected114 at risk
Syncope	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0011 affected114 at risk
Tremor	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0011 affected114 at risk
Nervous system disorders - Other	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0007 affected383 at risk EG0016 affected114 at risk
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0004 affected383 at risk EG0010 affected114 at risk
Blurred vision	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG00025 affected383 at risk EG0016 affected114 at risk
Cataract	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0010 affected114 at risk
Conjunctivitis	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0012 affected114 at risk
Dry eye	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG00044 affected383 at risk EG0015 affected114 at risk
Eye pain	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0011 affected114 at risk
Floaters	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0010 affected114 at risk
Retinal detachment	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Retinal tear	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Retinal vascular disorder	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected383 at risk EG0011 affected114 at risk
Watering eyes	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG00012 affected383 at risk EG0013 affected114 at risk
Eye disorders - Other	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG00016 affected383 at risk EG0015 affected114 at risk
Agitation	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected383 at risk EG0010 affected114 at risk
Anxiety	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG00038 affected383 at risk EG00123 affected114 at risk
Confusion	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Depression	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG00034 affected383 at risk EG0018 affected114 at risk
Hallucinations	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Insomnia	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG00058 affected383 at risk EG00130 affected114 at risk
Libido decreased	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected383 at risk EG0012 affected114 at risk
Restlessness	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0010 affected114 at risk
Psychiatric disorders - Other	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected383 at risk EG0014 affected114 at risk
Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG00021 affected383 at risk EG0014 affected114 at risk
Cough	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG00056 affected383 at risk EG00121 affected114 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG00027 affected383 at risk EG0018 affected114 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG00090 affected383 at risk EG00125 affected114 at risk
Laryngeal inflammation	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0011 affected114 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG00045 affected383 at risk EG00110 affected114 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0011 affected114 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0006 affected383 at risk EG0013 affected114 at risk
Postnasal drip	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG00015 affected383 at risk EG0012 affected114 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0005 affected383 at risk EG0010 affected114 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected383 at risk EG0010 affected114 at risk
Sinus disorder	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected383 at risk EG0010 affected114 at risk
Sleep apnea	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Sore throat	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG00021 affected383 at risk EG0018 affected114 at risk
Tracheal fistula	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected383 at risk EG0011 affected114 at risk
Voice alteration	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0010 affected114 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected383 at risk EG0012 affected114 at risk
Respiratory, thoracic and mediastinal disorders - Other	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG00017 affected383 at risk EG0016 affected114 at risk
Acute kidney injury	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Hematuria	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0005 affected383 at risk EG0010 affected114 at risk
Proteinuria	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Renal calculi	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Urinary frequency	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0007 affected383 at risk EG0012 affected114 at risk
Urinary incontinence	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected383 at risk EG0011 affected114 at risk
Urinary retention	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Urinary tract pain	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0008 affected383 at risk EG0010 affected114 at risk
Urinary urgency	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected383 at risk EG0010 affected114 at risk
Renal and urinary disorders - Other	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0010 affected114 at risk
Breast pain	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG00031 affected383 at risk EG0017 affected114 at risk
Dysmenorrhea	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Dyspareunia	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0010 affected114 at risk
Genital edema	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected383 at risk EG0011 affected114 at risk
Irregular menstruation	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG00013 affected383 at risk EG0012 affected114 at risk
Menorrhagia	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0009 affected383 at risk EG0011 affected114 at risk
Ovarian rupture	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Pelvic pain	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0010 affected114 at risk
Uterine hemorrhage	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected383 at risk EG0011 affected114 at risk
Vaginal discharge	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected383 at risk EG0010 affected114 at risk
Vaginal dryness	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG00018 affected383 at risk EG0018 affected114 at risk
Vaginal hemorrhage	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0010 affected114 at risk
Vaginal pain	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0011 affected114 at risk
Vaginal stricture	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected383 at risk EG0011 affected114 at risk
Reproductive system and breast disorders - Other	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG00014 affected383 at risk EG0012 affected114 at risk
Flushing	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected383 at risk EG0016 affected114 at risk
Hematoma	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected383 at risk EG0010 affected114 at risk
Hot flashes	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG00060 affected383 at risk EG00134 affected114 at risk
Hypertension	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG00078 affected383 at risk EG00129 affected114 at risk
Hypotension	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected383 at risk EG0011 affected114 at risk
Lymphedema	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0008 affected383 at risk EG0015 affected114 at risk
Phlebitis	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk
Thromboembolic event	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected383 at risk EG0010 affected114 at risk

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D008453	Maytansine
D018942	Macrolides
D007783	Lactones
D047029	Lactams, Macrocyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds

ID	Title	Description
BG000	Trastuzumab Emtansine (T-DM1)	T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
BG001	Paclitaxel + Trastuzumab (TH)	paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Trastuzumab Emtansine (T-DM1)	T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks	6	383	62	383	383	383
EG001	Paclitaxel + Trastuzumab	paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments	1	114	26	114	114	114

ID	Term
D000068878	Trastuzumab
D017239	Paclitaxel
D000080044	Ado-Trastuzumab Emtansine