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A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer Who Have Previously Received a Trastuzumab-Containing Regimen

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00932373
Recruitment Status : Completed
First Posted : July 3, 2009
Results First Posted : July 30, 2015
Last Update Posted : August 26, 2015
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Breast Cancer
Intervention Drug: trastuzumab-MCC-DM1
Enrollment 54
Recruitment Details Approximately four centers in the United States were to participate in the study to enroll approximately 50-60 patients. Between 25 April 2006 and 20 May 2008, 54 patients were enrolled and 52 were treated.
Pre-assignment Details Two patients enrolled but discontinued the study prior to receiving study treatment drug, thus 52 patients received at least one dose and are included in the baseline and safety analysis data.
Arm/Group Title Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 1.2 mg/kg Weekly Trastuzumab-MCC-DM1 1.6 mg/kg Weekly Trastuzumab-MCC-DM1 2.0 mg/kg Weekly Trastuzumab-MCC-DM1 2.4 mg/kg Weekly Trastuzumab-MCC-DM1 2.9 mg/kg Weekly
Hide Arm/Group Description Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
Period Title: Overall Study
Started 3 1 1 1 15 3 3 3 3 16 3
Completed 0 0 0 1 1 0 2 0 1 3 0
Not Completed 3 1 1 0 14 3 1 3 2 13 3
Reason Not Completed
Progressive disease             3             1             0             0             10             1             0             2             1             9             2
Adverse Event             0             0             0             0             2             1             0             1             0             2             1
Physician Decision             0             0             1             0             2             0             0             0             0             1             0
Dose limiting toxicity             0             0             0             0             0             1             0             0             0             0             0
Withdrawal by Subject             0             0             0             0             0             0             0             0             1             0             0
Clinical progression             0             0             0             0             0             0             1             0             0             0             0
Lack of Efficacy             0             0             0             0             0             0             0             0             0             1             0
Arm/Group Title Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 1.2 mg/kg Weekly Trastuzumab-MCC-DM1 1.6 mg/kg Weekly Trastuzumab-MCC-DM1 2.0 mg/kg Weekly Trastuzumab-MCC-DM1 2.4 mg/kg Weekly Trastuzumab-MCC-DM1 2.9 mg/kg Weekly Total
Hide Arm/Group Description Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week Total of all reporting groups
Overall Number of Baseline Participants 3 1 1 1 15 3 3 3 3 16 3 52
Hide Baseline Analysis Population Description
All summaries were based on data from the safety population (patients who received at least one dose of Trastuzumab-MCC-DM1). All summaries were presented for all patients and by dose level and schedule.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 1 participants 1 participants 1 participants 15 participants 3 participants 3 participants 3 participants 3 participants 16 participants 3 participants 52 participants
60.7  (10.1) 47.0  (0) 61.0  (0) 58.0  (0) 52.1  (10.3) 48.0  (6.0) 55.3  (10.0) 53.0  (6.1) 55.3  (3.2) 50.9  (14.0) 58.3  (11.0) 52.9  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 1 participants 1 participants 1 participants 15 participants 3 participants 3 participants 3 participants 3 participants 16 participants 3 participants 52 participants
Female
3
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
15
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
16
 100.0%
3
 100.0%
52
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 1 participants 1 participants 1 participants 15 participants 3 participants 3 participants 3 participants 3 participants 16 participants 3 participants 52 participants
3 1 1 1 15 3 3 3 3 16 3 52
1.Primary Outcome
Title Percentage of Participants With Adverse Events (AE), Serious Adverse Events (SAE), AEs With Grade >=3, and AEs Related To Treatment
Hide Description

The time frame for AEs is study treatment initiation until 30 days after last administration of study treatment or at the time of initiation of another anti-cancer therapy, which ever occurs first.

The time frame for SAEs is study treatment initiation until 90 days after last administration of study treatment or at the time of initiation of another anti-cancer therapy, which ever occurs first.
Time Frame Study treatment initiation until 30 or 90 days after last administration of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab-MCC-DM1
Arm/Group Title Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 1.2 mg/kg Weekly Trastuzumab-MCC-DM1 1.6 mg/kg Weekly Trastuzumab-MCC-DM1 2.0 mg/kg Weekly Trastuzumab-MCC-DM1 2.4 mg/kg Weekly Trastuzumab-MCC-DM1 2.9 mg/kg Weekly
Hide Arm/Group Description:
Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
Overall Number of Participants Analyzed 3 1 1 1 15 3 3 3 3 16 3
Measure Type: Number
Unit of Measure: percentage of participants
At least 1 AE 100 100 100 100 100 100 100 100 100 100 100
AEs with Grade >=3 33.3 100 0 0 46.7 100 33.3 66.7 66.7 81.3 33.3
At least 1 SAE 33.3 100 0 0 20 66.7 33.3 33.3 33.3 50 0
AEs related to treatment 66.7 100 100 100 93.3 100 100 66.7 100 87.5 100
2.Primary Outcome
Title Number of Patients With Dose Limiting Toxicities (DLTs)
Hide Description

DLT is defined as one of the following as per investigator related to study drug:

  • Grade ≥ 3 non-hematologic, non-hepatic major organ toxicity
  • Grade ≥ 3 cardiac toxicity, including cardiac troponin I elevation or any new segmental wall abnormality as determined by non-invasive cardiac imaging
  • Grade ≥ 4 thrombocytopenia
  • Grade ≥ 4 neutropenia (absolute neutrophil count < 500/μ L) lasting > 4 days or accompanied by fever
  • Grade ≥ 4 anemia
  • Grade ≥ 3 serum bilirubin, hepatic transaminase (alanine aminotransferase or aspartate aminotransferase), or alkaline phosphatase For patients with Grade 2 hepatic transaminase or alkaline phosphatase levels at baseline as a result of liver metastases or bone metastases, a hepatic transaminase or alkaline phosphatase level ≥ 10 times the upper limit of normal will be considered a DLT.
  • Weekly cohorts only: Toxicity preventing retreatment on Cycle 1, Day 8 or toxicity preventing re-treatment on Cycle 1, Days 15 and Day 22
Time Frame A minimum of 21 days after first dose of trastuzumab-MCC-DM1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all treated patients
Arm/Group Title Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 1.2 mg/kg Weekly Trastuzumab-MCC-DM1 1.6 mg/kg Weekly Trastuzumab-MCC-DM1 2.0 mg/kg Weekly Trastuzumab-MCC-DM1 2.4 mg/kg Weekly Trastuzumab-MCC-DM1 2.9 mg/kg Weekly
Hide Arm/Group Description:
Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
Overall Number of Participants Analyzed 3 1 1 1 15 3 3 3 3 16 3
Measure Type: Number
Unit of Measure: participants
0 0 0 0 0 2 0 0 0 1 2
3.Primary Outcome
Title Maximum Tolerated Dose (MTD)
Hide Description The highest dose level resulting in a DLT in ≤ 1 of 6 patients was declared the MTD.
Time Frame A minimum of 21 days after first dose of trastuzumab-MCC-DM1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety evaluable population: All participants who received at least 1 dose of trastuzumab-MCC-DM1
Arm/Group Title Trastuzumab-MCC-DM1 Every 3 Weeks Trastuzumab-MCC-DM1 Every Weeks
Hide Arm/Group Description:
Trastuzumab-MCC-DM1 0.3 to 4.8 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 1.2 to 2.9 mg/kg administered intravenously (IV) once every week
Overall Number of Participants Analyzed 24 28
Measure Type: Number
Unit of Measure: mg/kg
3.6 2.4
4.Primary Outcome
Title Pharmacokinetic (PK) Parameters After the First Dose: Maximum Observed Plasma Concentration Cmax for T-DM1 Concentrations
Hide Description [Not Specified]
Time Frame 3-Week and Weekly Cohorts: Cycle 1 Day 1 Pre-dose 30 minutes and 4 hours after the end of infusion; Cycle 1 Day 2, 3, 4, 8 (Pre-dose 30 minutes after the end of infusion) 11, 15 (Pre-dose 30 minutes after the end of infusion) and 18
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic-evaluable patients were defined as patients who received at least one dose of T-DM1 with at least one post-dose concentration data point.
Arm/Group Title Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 1.2 mg/kg Weekly Trastuzumab-MCC-DM1 1.6 mg/kg Weekly Trastuzumab-MCC-DM1 2.0 mg/kg Weekly Trastuzumab-MCC-DM1 2.4 mg/kg Weekly Trastuzumab-MCC-DM1 2.9 mg/kg Weekly
Hide Arm/Group Description:
Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
Overall Number of Participants Analyzed 3 1 1 1 15 3 3 3 3 16 3
Mean (Standard Deviation)
Unit of Measure: μg/mL
9.63  (1.73) 13.3  (0) 20.3  (0) 76.3  (0) 76.2  (19.1) 130  (7.77) 29.6  (5.66) 34.3  (4.81) 48.0  (9.56) 54.8  (12.6) 78.1  (33.9)
5.Primary Outcome
Title PK Parameters After the First Dose: Area Under the Plasma Concentration-time Curve From 0 to Infinity (AUC[0-∞] for T-DM1 Concentrations
Hide Description [Not Specified]
Time Frame 3-Week and Weekly Cohorts: Cycle 1 Day 1 Pre-dose 30 minutes and 4 hours after the end of infusion; Cycle 1 Day 2, 3, 4, 8 (Pre-dose 30 minutes after the end of infusion) 11, 15 (Pre-dose 30 minutes after the end of infusion) and 18
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic-evaluable patients were defined as patients who received at least one dose of T-DM1 with at least one post-dose concentration data point.
Arm/Group Title Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 1.2 mg/kg Weekly Trastuzumab-MCC-DM1 1.6 mg/kg Weekly Trastuzumab-MCC-DM1 2.0 mg/kg Weekly Trastuzumab-MCC-DM1 2.4 mg/kg Weekly Trastuzumab-MCC-DM1 2.9 mg/kg Weekly
Hide Arm/Group Description:
Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
Overall Number of Participants Analyzed 3 1 1 1 15 3 3 3 3 16 3
Mean (Standard Deviation)
Unit of Measure: day • μg/mL
14.5  (3.39) 24.5  (0) 42.9  (0) 330  (0) 300  (65.8) 673  (12.2) 76.2  (10.4) 130  (39.7) 175  (41.0) 199  (54.5) 212  (39.0)
6.Primary Outcome
Title PK Parameters After the First Dose: Terminal Half-life (t½) for T-DM1 Concentrations
Hide Description Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Time Frame 3-Week and Weekly Cohorts: Cycle 1 Day 1 Pre-dose 30 minutes and 4 hours after the end of infusion; Cycle 1 Day 2, 3, 4, 8 (Pre-dose 30 minutes after the end of infusion) 11, 15 (Pre-dose 30 minutes after the end of infusion) and 18
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic-evaluable patients were defined as patients who received at least one dose of T-DM1 with at least one post-dose concentration data point.
Arm/Group Title Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 1.2 mg/kg Weekly Trastuzumab-MCC-DM1 1.6 mg/kg Weekly Trastuzumab-MCC-DM1 2.0 mg/kg Weekly Trastuzumab-MCC-DM1 2.4 mg/kg Weekly Trastuzumab-MCC-DM1 2.9 mg/kg Weekly
Hide Arm/Group Description:
Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
Overall Number of Participants Analyzed 3 1 1 1 15 3 3 3 3 16 3
Mean (Standard Deviation)
Unit of Measure: day
1.3  (0.2) 1.3  (0) 1.3  (0) 2.2  (0) 3.1  (0.7) 4.1  (0.7) 2.3  (0.6) 3.4  (0.8) 3.1  (0.3) 3.3  (1.1) 2.9  (0.5)
7.Secondary Outcome
Title Percentage of Participants With an Objective Response
Hide Description The occurrence of an objective response was determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST). An objective response was defined as a complete response or a partial response as determined on 2 consecutive occasions ≥ 4 weeks apart. A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter of target lesions.
Time Frame Baseline to the end of the study (up to 3 years 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population: All enrolled participants who received treatment.
Arm/Group Title Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 1.2 mg/kg Weekly Trastuzumab-MCC-DM1 1.6 mg/kg Weekly Trastuzumab-MCC-DM1 2.0 mg/kg Weekly Trastuzumab-MCC-DM1 2.4 mg/kg Weekly Trastuzumab-MCC-DM1 2.9 mg/kg Weekly
Hide Arm/Group Description:
Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
Overall Number of Participants Analyzed 3 1 1 1 15 3 3 3 3 16 3
Measure Type: Number
Unit of Measure: percentage of participants
0 0 0 100 26.7 0 100 66.7 66.7 37.5 0
8.Secondary Outcome
Title Duration of Objective Response
Hide Description Duration of objective response was defined as the time from the initial response to disease progression or death from any cause within 30 days of the last dose of trastuzumab emtansine.
Time Frame Baseline to the end of the study (up to 3 years 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population: All enrolled participants who received treatment.
Arm/Group Title Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 1.2 mg/kg Weekly Trastuzumab-MCC-DM1 1.6 mg/kg Weekly Trastuzumab-MCC-DM1 2.0 mg/kg Weekly Trastuzumab-MCC-DM1 2.4 mg/kg Weekly
Hide Arm/Group Description:
Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
Overall Number of Participants Analyzed 1 4 3 2 2 6
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
10.5
(4.2 to 10.5)
NA [1] 
(NA to NA)
2.9 [1] 
(NA to NA)
NA [1] 
(NA to NA)
5.6 [1] 
(4.5 to NA)
[1]
Not estimable as the median and/or confidence interval limits were not reached.
9.Secondary Outcome
Title Progression-free Survival
Hide Description Progression-free survival was defined as the time from first dose of trastuzumab emtansine to documented disease progression or death from any cause within 30 days of the last dose of trastuzumab emtansine, whichever occurred earlier. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter of target lesions recorded since treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Time Frame Baseline to the end of the study (up to 3 years 2 months)
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Hide Analysis Population Description
Efficacy population: All enrolled participants who received treatment.
Arm/Group Title Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks Trastuzumab-MCC-DM1 1.2 mg/kg Weekly Trastuzumab-MCC-DM1 1.6 mg/kg Weekly Trastuzumab-MCC-DM1 2.0 mg/kg Weekly Trastuzumab-MCC-DM1 2.4 mg/kg Weekly Trastuzumab-MCC-DM1 2.9 mg/kg Weekly
Hide Arm/Group Description:
Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
Overall Number of Participants Analyzed 3 1 1 1 15 3 3 3 3 16 3
Median (95% Confidence Interval)
Unit of Measure: Months
2.7
(1.3 to 4.2)
1.7 [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
10.4
(3.4 to 17.1)
NA [1] 
(0.7 to NA)
NA [1] 
(20.8 to NA)
4.5 [1] 
(1.6 to NA)
NA [1] 
(7.2 to NA)
5.7
(1.3 to 10.9)
2.0
(1.3 to 2.8)
[1]
Not Estimable
10.Secondary Outcome
Title Percentage of Participants With Anti-therapeutic Antibodies to Trastuzumab Emtansine
Hide Description After the start of trastuzumab emtansine treatment, serum samples were collected every 3 weeks prior to trastuzumab emtansine dosing for detection of anti-therapeutic antibodies using a validated assay. A bridging antibody electrochemiluminescence assay (ECLA) was used to detect antibodies to trastuzumab emtansine. The assay utilized trastuzumab emtansine conjugated to biotin and a ruthenium label to form a complex with anti-trastuzumab emtansine antibodies. The antibody complex was captured by streptavidin-coated paramagnetic beads.
Time Frame Baseline to the end of the study (up to 3 years 2 months)
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trastuzumab-MCC-DM1 Every 3 Weeks Trastuzumab-MCC-DM1 Every Weeks
Hide Arm/Group Description:
Trastuzumab-MCC-DM1 0.3 to 4.8 mg/kg administered intravenously (IV) once every 3 weeks
Trastuzumab-MCC-DM1 1.2 to 2.9 mg/kg administered intravenously (IV) once every week
Overall Number of Participants Analyzed 24 28
Measure Type: Number
Unit of Measure: percentage of participants
Pre-dose (Cycle 1, Day 1) 0.0 3.7
Any Visit after Dosing 4.3 0.0
Time Frame Baseline to the end of the study (up to 3 years 2 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Trastuzumab-MCC-DM 0.3 mg/kg Every 3 Weeks Trastuzumab-MCC-DM 0.6 mg/kg Every 3 Weeks Trastuzumab-MCC-DM 1.2 mg/kg Every 3 Weeks Trastuzumab-MCC-DM 2.4 mg/kg Every 3 Weeks Trastuzumab-MCC-DM 3.6 mg/kg Every 3 Weeks Trastuzumab-MCC-DM 4.8 mg/kg Every 3 Weeks Trastuzumab-MCC-DM 1.2 mg/kg Weekly Trastuzumab-MCC-DM 1.6 mg/kg Weekly Trastuzumab-MCC-DM 2.0 mg/kg Weekly Trastuzumab-MCC-DM 2.4 mg/kg Weekly Trastuzumab-MCC-DM 2.9 mg/kg Weekly
Hide Arm/Group Description Trastuzumab-MCC-DM 0.3 mg/kg administered intravenously (IV) once every 3 weeks Trastuzumab-MCC-DM 0.6 mg/kg administered intravenously (IV) once every 3 weeks Trastuzumab-MCC-DM 1.2 mg/kg administered intravenously (IV) once every 3 weeks Trastuzumab-MCC-DM 2.4 mg/kg administered intravenously (IV) once every 3 weeks Trastuzumab-MCC-DM 3.6 mg/kg administered intravenously (IV) once every 3 weeks Trastuzumab-MCC-DM 4.8 mg/kg administered intravenously (IV) once every 3 weeks Trastuzumab-MCC-DM 1.2 mg/kg administered intravenously (IV) once a week Trastuzumab-MCC-DM 1.6 mg/kg administered intravenously (IV) once a week Trastuzumab-MCC-DM 2.0 mg/kg administered intravenously (IV) once a week Trastuzumab-MCC-DM 2.4 mg/kg administered intravenously (IV) once a week 2.9 mg/kg administered intravenously (IV) once a week
All-Cause Mortality
Trastuzumab-MCC-DM 0.3 mg/kg Every 3 Weeks Trastuzumab-MCC-DM 0.6 mg/kg Every 3 Weeks Trastuzumab-MCC-DM 1.2 mg/kg Every 3 Weeks Trastuzumab-MCC-DM 2.4 mg/kg Every 3 Weeks Trastuzumab-MCC-DM 3.6 mg/kg Every 3 Weeks Trastuzumab-MCC-DM 4.8 mg/kg Every 3 Weeks Trastuzumab-MCC-DM 1.2 mg/kg Weekly Trastuzumab-MCC-DM 1.6 mg/kg Weekly Trastuzumab-MCC-DM 2.0 mg/kg Weekly Trastuzumab-MCC-DM 2.4 mg/kg Weekly Trastuzumab-MCC-DM 2.9 mg/kg Weekly
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Trastuzumab-MCC-DM 0.3 mg/kg Every 3 Weeks Trastuzumab-MCC-DM 0.6 mg/kg Every 3 Weeks Trastuzumab-MCC-DM 1.2 mg/kg Every 3 Weeks Trastuzumab-MCC-DM 2.4 mg/kg Every 3 Weeks Trastuzumab-MCC-DM 3.6 mg/kg Every 3 Weeks Trastuzumab-MCC-DM 4.8 mg/kg Every 3 Weeks Trastuzumab-MCC-DM 1.2 mg/kg Weekly Trastuzumab-MCC-DM 1.6 mg/kg Weekly Trastuzumab-MCC-DM 2.0 mg/kg Weekly Trastuzumab-MCC-DM 2.4 mg/kg Weekly Trastuzumab-MCC-DM 2.9 mg/kg Weekly
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/3 (33.33%)      1/1 (100.00%)      0/1 (0.00%)      0/1 (0.00%)      3/15 (20.00%)      2/3 (66.67%)      1/3 (33.33%)      1/3 (33.33%)      1/3 (33.33%)      8/16 (50.00%)      0/3 (0.00%)    
General disorders                       
Pain † 1  0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1 0/3 (0.00%)  0
Infections and infestations                       
Cellulitis † 1  0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1 0/3 (0.00%)  0
Influenza † 1  0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1 0/3 (0.00%)  0
Osteomyelitis † 1  0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1 0/3 (0.00%)  0
Pneumonia † 1  0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 2/16 (12.50%)  2 0/3 (0.00%)  0
Injury, poisoning and procedural complications                       
Humerus Fracture † 1  0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/16 (0.00%)  0 0/3 (0.00%)  0
Nervous system disorders                       
Brain Oedema † 1  0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/16 (0.00%)  0 0/3 (0.00%)  0
Cerebral Haemorrhage † 1  0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/16 (0.00%)  0 0/3 (0.00%)  0
Convulsion † 1  0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/15 (6.67%)  1 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/16 (0.00%)  0 0/3 (0.00%)  0
Dysarthria † 1  0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/15 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/16 (0.00%)  0 0/3 (0.00%)  0
Hepatic Encephalopathy † 1  0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1 0/3 (0.00%)  0
Psychiatric disorders                       
Confusional State † 1  0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/16 (0.00%)  0 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                       
Dyspnoea † 1  1/3 (33.33%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1 0/3 (0.00%)  0
Pleural Effusion † 1  0/3 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/16 (0.00%)  0 0/3 (0.00%)  0
Pneumonitis † 1  0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/16 (0.00%)  0 0/3 (0.00%)  0
Pulmonary Embolism † 1  0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/15 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1 0/3 (0.00%)  0
Pulmonary Hypertension † 1  0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/15 (6.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/16 (0.00%)  0 0/3 (0.00%)  0
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Trastuzumab-MCC-DM 0.3 mg/kg Every 3 Weeks Trastuzumab-MCC-DM 0.6 mg/kg Every 3 Weeks Trastuzumab-MCC-DM 1.2 mg/kg Every 3 Weeks Trastuzumab-MCC-DM 2.4 mg/kg Every 3 Weeks Trastuzumab-MCC-DM 3.6 mg/kg Every 3 Weeks Trastuzumab-MCC-DM 4.8 mg/kg Every 3 Weeks Trastuzumab-MCC-DM 1.2 mg/kg Weekly Trastuzumab-MCC-DM 1.6 mg/kg Weekly Trastuzumab-MCC-DM 2.0 mg/kg Weekly Trastuzumab-MCC-DM 2.4 mg/kg Weekly Trastuzumab-MCC-DM 2.9 mg/kg Weekly
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      1/1 (100.00%)      1/1 (100.00%)      1/1 (100.00%)      15/15 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      15/16 (93.75%)      3/3 (100.00%)    
Blood and lymphatic system disorders                       
NEUTROPENIA * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  1/1 (100.00%)  0/15 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  1/16 (6.25%)  0/3 (0.00%) 
IRON DEFICIENCY ANAEMIA * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  1/15 (6.67%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  1/16 (6.25%)  0/3 (0.00%) 
ANAEMIA * 1  0/3 (0.00%)  0/1 (0.00%)  1/1 (100.00%)  0/1 (0.00%)  6/15 (40.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  6/16 (37.50%)  1/3 (33.33%) 
THROMBOCYTOPENIA * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  1/1 (100.00%)  9/15 (60.00%)  3/3 (100.00%)  1/3 (33.33%)  1/3 (33.33%)  2/3 (66.67%)  6/16 (37.50%)  2/3 (66.67%) 
Cardiac disorders                       
TACHYCARDIA * 1  1/3 (33.33%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/15 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/16 (0.00%)  0/3 (0.00%) 
Eye disorders                       
LACRIMATION INCREASED * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/15 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  2/16 (12.50%)  0/3 (0.00%) 
DRY EYE * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  1/15 (6.67%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  3/16 (18.75%)  0/3 (0.00%) 
EYE PAIN * 1  1/3 (33.33%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/15 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/16 (6.25%)  0/3 (0.00%) 
CONJUNCTIVITIS * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  1/15 (6.67%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  2/16 (12.50%)  0/3 (0.00%) 
VISION BLURRED * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/15 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/16 (6.25%)  0/3 (0.00%) 
Gastrointestinal disorders                       
ORAL PAIN * 1  1/3 (33.33%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/15 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/16 (0.00%)  0/3 (0.00%) 
DYSPEPSIA * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/15 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  2/16 (12.50%)  0/3 (0.00%) 
VOMITING * 1  1/3 (33.33%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  3/15 (20.00%)  0/3 (0.00%)  2/3 (66.67%)  1/3 (33.33%)  0/3 (0.00%)  6/16 (37.50%)  0/3 (0.00%) 
DIARRHOEA * 1  1/3 (33.33%)  0/1 (0.00%)  0/1 (0.00%)  1/1 (100.00%)  2/15 (13.33%)  0/3 (0.00%)  3/3 (100.00%)  1/3 (33.33%)  2/3 (66.67%)  6/16 (37.50%)  1/3 (33.33%) 
NAUSEA * 1  2/3 (66.67%)  1/1 (100.00%)  0/1 (0.00%)  1/1 (100.00%)  6/15 (40.00%)  1/3 (33.33%)  3/3 (100.00%)  1/3 (33.33%)  1/3 (33.33%)  7/16 (43.75%)  2/3 (66.67%) 
DRY MOUTH * 1  0/3 (0.00%)  0/1 (0.00%)  1/1 (100.00%)  1/1 (100.00%)  3/15 (20.00%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  1/3 (33.33%)  7/16 (43.75%)  0/3 (0.00%) 
RETCHING * 1  0/3 (0.00%)  1/1 (100.00%)  0/1 (0.00%)  0/1 (0.00%)  0/15 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/16 (0.00%)  0/3 (0.00%) 
STOMATITIS * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  1/1 (100.00%)  0/15 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  1/16 (6.25%)  0/3 (0.00%) 
CONSTIPATION * 1  2/3 (66.67%)  0/1 (0.00%)  0/1 (0.00%)  1/1 (100.00%)  3/15 (20.00%)  1/3 (33.33%)  1/3 (33.33%)  0/3 (0.00%)  2/3 (66.67%)  4/16 (25.00%)  2/3 (66.67%) 
General disorders                       
MUCOSAL INFLAMMATION * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  1/1 (100.00%)  1/15 (6.67%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/16 (0.00%)  0/3 (0.00%) 
OEDEMA PERIPHERAL * 1  1/3 (33.33%)  0/1 (0.00%)  1/1 (100.00%)  0/1 (0.00%)  1/15 (6.67%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/16 (0.00%)  0/3 (0.00%) 
CHEST PAIN * 1  1/3 (33.33%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  3/15 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/16 (6.25%)  0/3 (0.00%) 
FATIGUE * 1  1/3 (33.33%)  0/1 (0.00%)  0/1 (0.00%)  1/1 (100.00%)  9/15 (60.00%)  1/3 (33.33%)  3/3 (100.00%)  1/3 (33.33%)  3/3 (100.00%)  10/16 (62.50%)  1/3 (33.33%) 
CHILLS * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  1/15 (6.67%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  1/3 (33.33%)  0/16 (0.00%)  1/3 (33.33%) 
INFLUENZA LIKE ILLNESS * 1  1/3 (33.33%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/15 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/16 (0.00%)  0/3 (0.00%) 
PYREXIA * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  3/15 (20.00%)  0/3 (0.00%)  2/3 (66.67%)  1/3 (33.33%)  2/3 (66.67%)  2/16 (12.50%)  1/3 (33.33%) 
ASTHENIA * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/15 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/16 (0.00%)  0/3 (0.00%) 
FACIAL PAIN * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/15 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/16 (0.00%)  0/3 (0.00%) 
FACE OEDEMA * 1  1/3 (33.33%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/15 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/16 (0.00%)  0/3 (0.00%) 
Immune system disorders                       
DRUG HYPERSENSITIVITY * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/15 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/16 (0.00%)  0/3 (0.00%) 
Infections and infestations                       
URINARY TRACT INFECTION * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  5/15 (33.33%)  1/3 (33.33%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  1/16 (6.25%)  0/3 (0.00%) 
NASOPHARYNGITIS * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  1/1 (100.00%)  3/15 (20.00%)  0/3 (0.00%)  2/3 (66.67%)  0/3 (0.00%)  1/3 (33.33%)  2/16 (12.50%)  0/3 (0.00%) 
TOOTH ABSCESS * 1  1/3 (33.33%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/15 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/16 (0.00%)  0/3 (0.00%) 
RESPIRATORY TRACT INFECTION * 1  1/3 (33.33%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/15 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/16 (0.00%)  0/3 (0.00%) 
Injury, poisoning and procedural complications                       
JOINT SPRAIN * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/15 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/16 (0.00%)  0/3 (0.00%) 
SUBDURAL HAEMATOMA * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/15 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/16 (0.00%)  0/3 (0.00%) 
Investigations                       
ALANINE AMINOTRANSFERASE * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  1/15 (6.67%)  2/3 (66.67%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  2/16 (12.50%)  0/3 (0.00%) 
LIPASE INCREASED * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  1/15 (6.67%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/16 (6.25%)  0/3 (0.00%) 
WEIGHT DECREASED * 1  1/3 (33.33%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/15 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/16 (6.25%)  0/3 (0.00%) 
BLOOD ALKALINE PHOSPHATASE INCREASED * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  1/15 (6.67%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  1/16 (6.25%)  0/3 (0.00%) 
ASPARTATE AMINOTRANSFERASE INCREASED * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  1/1 (100.00%)  2/15 (13.33%)  2/3 (66.67%)  1/3 (33.33%)  1/3 (33.33%)  2/3 (66.67%)  8/16 (50.00%)  1/3 (33.33%) 
LIVER FUNCTION TEST ABNORMAL * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  4/15 (26.67%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  2/16 (12.50%)  1/3 (33.33%) 
Metabolism and nutrition disorders                       
HYPOKALAEMIA * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  4/15 (26.67%)  1/3 (33.33%)  2/3 (66.67%)  1/3 (33.33%)  1/3 (33.33%)  2/16 (12.50%)  0/3 (0.00%) 
HYPOCALCAEMIA * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  1/1 (100.00%)  0/15 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/16 (0.00%)  0/3 (0.00%) 
DECREASED APPETITE * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  1/15 (6.67%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  3/16 (18.75%)  0/3 (0.00%) 
FLUID RETENTION * 1  0/3 (0.00%)  0/1 (0.00%)  1/1 (100.00%)  0/1 (0.00%)  0/15 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/16 (0.00%)  0/3 (0.00%) 
HYPONATRAEMIA * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/15 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/16 (0.00%)  0/3 (0.00%) 
ANOREXIA * 1  2/3 (66.67%)  0/1 (0.00%)  1/1 (100.00%)  0/1 (0.00%)  2/15 (13.33%)  0/3 (0.00%)  2/3 (66.67%)  0/3 (0.00%)  0/3 (0.00%)  4/16 (25.00%)  1/3 (33.33%) 
Musculoskeletal and connective tissue disorders                       
MYALGIA * 1  1/3 (33.33%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  2/15 (13.33%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/16 (0.00%)  0/3 (0.00%) 
PATHOLOGICAL FRACTURE * 1  0/3 (0.00%)  0/1 (0.00%)  1/1 (100.00%)  0/1 (0.00%)  0/15 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/16 (0.00%)  0/3 (0.00%) 
MUSCULOSKELETAL CHEST PAIN * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  4/15 (26.67%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/16 (0.00%)  0/3 (0.00%) 
ARTHRALGIA * 1  1/3 (33.33%)  0/1 (0.00%)  0/1 (0.00%)  1/1 (100.00%)  3/15 (20.00%)  1/3 (33.33%)  1/3 (33.33%)  0/3 (0.00%)  2/3 (66.67%)  1/16 (6.25%)  1/3 (33.33%) 
PAIN IN EXTREMITY * 1  1/3 (33.33%)  0/1 (0.00%)  0/1 (0.00%)  1/1 (100.00%)  1/15 (6.67%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  1/16 (6.25%)  0/3 (0.00%) 
NECK PAIN * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  1/15 (6.67%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/16 (6.25%)  0/3 (0.00%) 
FLANK PAIN * 1  0/3 (0.00%)  1/1 (100.00%)  0/1 (0.00%)  0/1 (0.00%)  2/15 (13.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/16 (0.00%)  0/3 (0.00%) 
MUSCULOSKELETAL PAIN * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  1/15 (6.67%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  1/16 (6.25%)  1/3 (33.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                       
TUMOUR PAIN * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  1/15 (6.67%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  0/16 (0.00%)  0/3 (0.00%) 
TUMOUR NECROSIS * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/15 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/16 (0.00%)  0/3 (0.00%) 
Nervous system disorders                       
SYNCOPE * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/15 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/16 (0.00%)  0/3 (0.00%) 
DYSGEUSIA * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  1/15 (6.67%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  3/16 (18.75%)  0/3 (0.00%) 
DIZZINESS * 1  1/3 (33.33%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  2/15 (13.33%)  1/3 (33.33%)  1/3 (33.33%)  1/3 (33.33%)  0/3 (0.00%)  2/16 (12.50%)  0/3 (0.00%) 
NEUROPATHY PERIPHERAL * 1  1/3 (33.33%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  1/15 (6.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  3/16 (18.75%)  0/3 (0.00%) 
HEADACHE * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  1/1 (100.00%)  5/15 (33.33%)  1/3 (33.33%)  2/3 (66.67%)  1/3 (33.33%)  1/3 (33.33%)  7/16 (43.75%)  0/3 (0.00%) 
Psychiatric disorders                       
DISORIENTATION * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/15 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/16 (0.00%)  0/3 (0.00%) 
INSOMNIA * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  1/15 (6.67%)  0/3 (0.00%)  2/3 (66.67%)  0/3 (0.00%)  2/3 (66.67%)  3/16 (18.75%)  0/3 (0.00%) 
MENTAL STATUS CHANGES * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/15 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/16 (0.00%)  0/3 (0.00%) 
Renal and urinary disorders                       
NEPHROLITHIASIS * 1  0/3 (0.00%)  1/1 (100.00%)  0/1 (0.00%)  0/1 (0.00%)  0/15 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/16 (0.00%)  0/3 (0.00%) 
Reproductive system and breast disorders                       
MENSTRUAL DISORDER * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/15 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/16 (0.00%)  0/3 (0.00%) 
Respiratory, thoracic and mediastinal disorders                       
DYSPNOEA * 1  1/3 (33.33%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  4/15 (26.67%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  9/16 (56.25%)  0/3 (0.00%) 
PLEURAL EFFUSION * 1  0/3 (0.00%)  1/1 (100.00%)  0/1 (0.00%)  0/1 (0.00%)  0/15 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/16 (0.00%)  0/3 (0.00%) 
HAEMOPTYSIS * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/15 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/16 (6.25%)  0/3 (0.00%) 
PRODUCTIVE COUGH * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/15 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/16 (0.00%)  0/3 (0.00%) 
RALES * 1  1/3 (33.33%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/15 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/16 (0.00%)  0/3 (0.00%) 
EPISTAXIS * 1  1/3 (33.33%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  3/15 (20.00%)  1/3 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  2/3 (66.67%)  5/16 (31.25%)  0/3 (0.00%) 
COUGH * 1  1/3 (33.33%)  1/1 (100.00%)  0/1 (0.00%)  0/1 (0.00%)  4/15 (26.67%)  1/3 (33.33%)  1/3 (33.33%)  1/3 (33.33%)  2/3 (66.67%)  5/16 (31.25%)  0/3 (0.00%) 
Skin and subcutaneous tissue disorders                       
PERIORBITAL OEDEMA * 1  1/3 (33.33%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/15 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/16 (0.00%)  0/3 (0.00%) 
HYPERHIDROSIS * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/15 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/16 (0.00%)  0/3 (0.00%) 
DRY SKIN * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  1/15 (6.67%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  2/16 (12.50%)  0/3 (0.00%) 
RASH MACULAR * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  1/1 (100.00%)  0/15 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/16 (0.00%)  0/3 (0.00%) 
COLD SWEAT * 1  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/15 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/16 (0.00%)  0/3 (0.00%) 
Vascular disorders                       
FLUSHING * 1  1/3 (33.33%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/15 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/16 (0.00%)  0/3 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.0)
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
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Name/Title: Medical Communications
Organization: Genentech, Inc.
Phone: 800 821-8590
EMail: genentech@druginfo.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00932373    
Other Study ID Numbers: TDM3569g
First Submitted: June 30, 2009
First Posted: July 3, 2009
Results First Submitted: July 1, 2015
Results First Posted: July 30, 2015
Last Update Posted: August 26, 2015