Trial Outcomes & Findings for A Study of Trastuzumab Emtansine in Indian Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Treatment With Trastuzumab and a Taxane (NCT NCT02658734)

NCT ID: NCT02658734

Last Updated: 2021-04-02

Results Overview

Adverse events (AEs) grading was completed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 70 participants
• Primary outcome timeframe: From cycle 1 up to approximately 3 years
• Results posted on: 2021-04-02

Participant Flow

The study was conducted at 13 centres across India.

Participant milestones

Measure	Trastuzumab Emtansine 3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Overall Study STARTED	70
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	57

Reasons for withdrawal

Measure	Trastuzumab Emtansine 3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Overall Study Adverse Event	2
Overall Study Death	4
Overall Study Lost to Follow-up	7
Overall Study Withdrawal of Consent	16
Overall Study Disease Progression	28

Baseline Characteristics

A Study of Trastuzumab Emtansine in Indian Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Treatment With Trastuzumab and a Taxane

Baseline characteristics by cohort

Measure	Trastuzumab Emtansine n=70 Participants 3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Age, Continuous	50 Years STANDARD_DEVIATION 11.50 • n=5 Participants
Sex: Female, Male Female	70 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	70 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: From cycle 1 up to approximately 3 years

Population: Safety Population included all enrolled participants who received at least one dose of study medication.

Adverse events (AEs) grading was completed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.

Outcome measures

Measure	Trastuzumab Emtansine n=70 Participants 3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Severity of Adverse Events Grade 1	53 Participants
Severity of Adverse Events Grade 2	40 Participants
Severity of Adverse Events Grade 3	18 Participants
Severity of Adverse Events Grade 4	2 Participants
Severity of Adverse Events Grade 5	12 Participants

PRIMARY outcome

Timeframe: From cycle 1 up to approximately 3 years

Population: Safety Population included all enrolled participants who received at least one dose of study medication.

An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with the treatment. An adverse event was therefore any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsened during the study were also considered as adverse events.

Outcome measures

Measure	Trastuzumab Emtansine n=70 Participants 3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Percentage of Participants With Adverse Events	90.0 Percentage of Participants

SECONDARY outcome

Timeframe: From cycle 1 up to approximately 3 years

Population: Safety Population included all enrolled participants who received at least one dose of study medication.

SAEs were defined as any AE that fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/ birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.

Outcome measures

Measure	Trastuzumab Emtansine n=70 Participants 3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Percentage of Participants With Serious Adverse Events (SAEs)	40 Percentage of Participants

SECONDARY outcome

Timeframe: From cycle 1 up to approximately 3 years

Population: Safety Population included all enrolled participants who received at least one dose of study medication.

Severity refered to the intensity of an AE (e.g., rated as mild, moderate, or severe, or according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria.

Outcome measures

Measure	Trastuzumab Emtansine n=70 Participants 3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Severity of SAEs as Per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Grade 4	3 Participants
Severity of SAEs as Per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Grade 1	1 Participants
Severity of SAEs as Per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Grade 2	13 Participants
Severity of SAEs as Per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Grade 3	10 Participants
Severity of SAEs as Per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 Grade 5	6 Participants

SECONDARY outcome

Timeframe: From cycle 1 up to approximately 3 years

Population: Safety Population included all enrolled participants who received at least one dose of study medication.

Non-serious AEs of special interest included cases of severe drug-induced liver injury and suspected transmission of an infectious agent by the study drug.

Outcome measures

Measure	Trastuzumab Emtansine n=70 Participants 3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Percentage of Participants With Non-Serious Adverse Events of Special Interest	2.9 Percentage of Participants

SECONDARY outcome

Timeframe: From cycle 1 up to approximately 3 years

Population: Safety Population included all enrolled participants who received at least one dose of study medication.

Outcome measures

Measure	Trastuzumab Emtansine n=70 Participants 3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Laboratory Results Abnormalities Chloride - High	30 Number of Participants
Laboratory Results Abnormalities Lactate Dehydrogenase - Low	8 Number of Participants
Laboratory Results Abnormalities Lactate Dehydrogenase - High	52 Number of Participants
Laboratory Results Abnormalities Protein - Low	10 Number of Participants
Laboratory Results Abnormalities Protein - High	30 Number of Participants
Laboratory Results Abnormalities Basophils - High	1 Number of Participants
Laboratory Results Abnormalities Basophils/Leukocytes - Low	13 Number of Participants
Laboratory Results Abnormalities Basophils/Leukocytes - High	6 Number of Participants
Laboratory Results Abnormalities Monocytes - High	2 Number of Participants
Laboratory Results Abnormalities Hematocrit - Low	57 Number of Participants
Laboratory Results Abnormalities Hematocrit - High	1 Number of Participants
Laboratory Results Abnormalities Lymphocytes/Leukocytes - Low	38 Number of Participants
Laboratory Results Abnormalities Lymphocytes/Leukocytes - High	19 Number of Participants
Laboratory Results Abnormalities Monocytes/Leukocytes - Low	8 Number of Participants
Laboratory Results Abnormalities Monocytes/Leukocytes - High	21 Number of Participants
Laboratory Results Abnormalities Neutrophils/Leukocytes - Low	14 Number of Participants
Laboratory Results Abnormalities Neutrophils/Leukocytes - High	13 Number of Participants
Laboratory Results Abnormalities Other Cells - High	3 Number of Participants
Laboratory Results Abnormalities Other Cells/Leukocytes - High	6 Number of Participants
Laboratory Results Abnormalities Erythrocytes - Low	41 Number of Participants
Laboratory Results Abnormalities Erythrocytes - High	15 Number of Participants
Laboratory Results Abnormalities Eosinophils/Leukocytes - Low	33 Number of Participants
Laboratory Results Abnormalities Eosinophils/Leukocytes - High	13 Number of Participants
Laboratory Results Abnormalities Bilirubin - Low	5 Number of Participants
Laboratory Results Abnormalities Bilirubin - High	22 Number of Participants
Laboratory Results Abnormalities Bicarbonate - Low	4 Number of Participants
Laboratory Results Abnormalities Bicarbonate - High	11 Number of Participants
Laboratory Results Abnormalities Direct Bilirubin - High	27 Number of Participants
Laboratory Results Abnormalities Blood Urea Nitrogen - Low	21 Number of Participants
Laboratory Results Abnormalities Blood Urea Nitrogen - High	10 Number of Participants
Laboratory Results Abnormalities Chloride - Low	20 Number of Participants
Laboratory Results Abnormalities Urea - Low	21 Number of Participants
Laboratory Results Abnormalities Urea - High	10 Number of Participants
Laboratory Results Abnormalities Partial Thromboplastin Time - Low	22 Number of Participants
Laboratory Results Abnormalities Partial Thromboplastin Time - High	37 Number of Participants

SECONDARY outcome

Timeframe: From cycle 1 up to approximately 3 years

Population: Safety Population included all enrolled participants who received at least one dose of study medication.

Outcome measures

Measure	Trastuzumab Emtansine n=70 Participants 3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Percentage of Participants With Adverse Events Leading to Discontinuation of Study Medication	8.6 Percentage of Participants

SECONDARY outcome

Timeframe: From cycle 1 up to approximately 3 years

Population: Safety Population included all enrolled participants who received at least one dose of study medication.

Outcome measures

Measure	Trastuzumab Emtansine n=70 Participants 3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Percentage of Participants With Adverse Events Leading to Modification of Study Medication Dose Reduced	1 Participants
Percentage of Participants With Adverse Events Leading to Modification of Study Medication Drug Interrupted	11 Participants

SECONDARY outcome

Timeframe: From cycle 1 up to approximately 3 years

Population: Safety Population included all enrolled participants who received at least one dose of study medication.

Outcome measures

Measure	Trastuzumab Emtansine n=70 Participants 3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Percentage of Participants With Adverse Events Leading to Interruption of Study Medication	15.7 Percentage of Participants

SECONDARY outcome

Timeframe: From cycle 1 up to approximately 3 years

Exposure to study drug was the amount of study drug received over time (weeks).

Outcome measures

Measure	Trastuzumab Emtansine n=70 Participants 3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Exposure to Study Drug	39.60 Weeks Standard Deviation 32.00

SECONDARY outcome

Timeframe: From cycle 1 up to approximately 3 years

Population: Safety Population included all enrolled participants who received at least one dose of study medication.

Hy's law criteria for potential drug-induced liver injury included elevated aminotransferase enzymes (ALT/AST) with concurrent elevated serum total bilirubin, gross jaundice, clinical disability and the need for hospital care.

Outcome measures

Measure	Trastuzumab Emtansine n=70 Participants 3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Percentage of Participants With Drug-Induced Liver Injury Meeting Hy's Law Criteria	0 Percentage of Participants

SECONDARY outcome

Timeframe: From cycle 1 up to approximately 3 years

Population: Safety Population included all enrolled participants who received at least one dose of study medication.

Outcome measures

Measure	Trastuzumab Emtansine n=70 Participants 3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Percentage of Participants With Congestive Heart Failure	0 Percetnage of Participants

SECONDARY outcome

Timeframe: From baseline to every three cycles of treatment up to Cycle 39 Day 1, and at the 2-days post-treatment, safety follow-up visits 1 and 3

Population: Safety Population included all enrolled participants who received at least one dose of study medication.

Outcome measures

Measure	Trastuzumab Emtansine n=70 Participants 3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Change in Left Ventricular Ejection Fraction (LVEF) as Measured by Echocardiogram Baseline	59.49 Percentage of LVEF Standard Deviation 3.33
Change in Left Ventricular Ejection Fraction (LVEF) as Measured by Echocardiogram Cycle 03 Day 1	0.08 Percentage of LVEF Standard Deviation 3.26
Change in Left Ventricular Ejection Fraction (LVEF) as Measured by Echocardiogram Cycle 06 Day 1	0.20 Percentage of LVEF Standard Deviation 4.50
Change in Left Ventricular Ejection Fraction (LVEF) as Measured by Echocardiogram Cycle 09 Day 1	0.23 Percentage of LVEF Standard Deviation 3.76
Change in Left Ventricular Ejection Fraction (LVEF) as Measured by Echocardiogram Cycle 12 Day 1	0.06 Percentage of LVEF Standard Deviation 4.24
Change in Left Ventricular Ejection Fraction (LVEF) as Measured by Echocardiogram Cycle 15 Day 1	0.38 Percentage of LVEF Standard Deviation 4.40
Change in Left Ventricular Ejection Fraction (LVEF) as Measured by Echocardiogram Cycle 18 Day 1	0.15 Percentage of LVEF Standard Deviation 5.98
Change in Left Ventricular Ejection Fraction (LVEF) as Measured by Echocardiogram Cycle 21 Day 1	2.50 Percentage of LVEF Standard Deviation 3.78
Change in Left Ventricular Ejection Fraction (LVEF) as Measured by Echocardiogram Cycle 24 Day 1	0.23 Percentage of LVEF Standard Deviation 2.89
Change in Left Ventricular Ejection Fraction (LVEF) as Measured by Echocardiogram Cycle 27 Day 1	-0.60 Percentage of LVEF Standard Deviation 3.86
Change in Left Ventricular Ejection Fraction (LVEF) as Measured by Echocardiogram Cycle 30 Day 1	-0.17 Percentage of LVEF Standard Deviation 1.33
Change in Left Ventricular Ejection Fraction (LVEF) as Measured by Echocardiogram Cycle 33 Day 1	-1.20 Percentage of LVEF Standard Deviation 2.39
Change in Left Ventricular Ejection Fraction (LVEF) as Measured by Echocardiogram Cycle 36 Day 1	0 Percentage of LVEF Standard Deviation NA The standard deviation couldn't be calculated from one participant
Change in Left Ventricular Ejection Fraction (LVEF) as Measured by Echocardiogram Cycle 39 Day 1	0 Percentage of LVEF Standard Deviation NA The standard deviation couldn't be calculated from one participant
Change in Left Ventricular Ejection Fraction (LVEF) as Measured by Echocardiogram Safety Follow-Up 1	1.28 Percentage of LVEF Standard Deviation 3.80
Change in Left Ventricular Ejection Fraction (LVEF) as Measured by Echocardiogram Safety Follow-Up 3	1.38 Percentage of LVEF Standard Deviation 4.00

SECONDARY outcome

Timeframe: From cycle 1 up to approximately 3 years

Population: ITT population included all participants enrolled in the study.

ORR was based on the best (confirmed) overall response (BOR). ORR was defined as the number (%) of participants with confirmed complete response (CR) or partial response (PR) where the confirmation was performed no less than 4 weeks after the criteria for response were first met.

Outcome measures

Measure	Trastuzumab Emtansine n=70 Participants 3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Overall Response Rate (ORR)	16 Participants

SECONDARY outcome

Timeframe: From cycle 1 up to approximately 3 years

Population: ITT population included all participants enrolled in the study.

PFS was defined as the time from the date of enrollment until the date of first documented progression of disease or the date of death (by any cause in the absence of progression) whichever occurred first.

Outcome measures

Measure	Trastuzumab Emtansine n=70 Participants 3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Progression-Free Survival (PFS)	14.0 Months Interval 8.0 to 17.0

SECONDARY outcome

Timeframe: From cycle 1 up to approximately 3 years

Population: ITT population included all participants enrolled in the study.

Overall survival was defined as the time from the date of enrollment until the date of death due to any cause. Participants not known to have died at the time of final analysis were censored based on the last recorded date on which the subject was known to be alive.

Outcome measures

Measure	Trastuzumab Emtansine n=70 Participants 3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Overall Survival (OS)	NA Months Interval 25.0 to The median duration of OS was not estimable since the OS was not achieved.

Adverse Events

Trastuzumab Emtansine

Serious events: 28 serious events

Other events: 51 other events

Deaths: 12 deaths

Serious adverse events

Measure	Trastuzumab Emtansine n=70 participants at risk 3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Blood and lymphatic system disorders THROMBOCYTOPENIA	5.7% 4/70 • Number of events 4 • From cycle 1 up to approximately 3 years
Cardiac disorders CARDIAC ARREST	1.4% 1/70 • Number of events 1 • From cycle 1 up to approximately 3 years
Cardiac disorders CARDIO-RESPIRATORY ARREST	1.4% 1/70 • Number of events 1 • From cycle 1 up to approximately 3 years
Eye disorders CATARACT	1.4% 1/70 • Number of events 1 • From cycle 1 up to approximately 3 years
Eye disorders VISION BLURRED	1.4% 1/70 • Number of events 1 • From cycle 1 up to approximately 3 years
Gastrointestinal disorders ABDOMINAL PAIN	1.4% 1/70 • Number of events 1 • From cycle 1 up to approximately 3 years
General disorders DEATH	5.7% 4/70 • Number of events 4 • From cycle 1 up to approximately 3 years
General disorders PYREXIA	1.4% 1/70 • Number of events 1 • From cycle 1 up to approximately 3 years
Infections and infestations URINARY TRACT INFECTION	1.4% 1/70 • Number of events 1 • From cycle 1 up to approximately 3 years
Injury, poisoning and procedural complications FRACTURE DISPLACEMENT	1.4% 1/70 • Number of events 1 • From cycle 1 up to approximately 3 years
Injury, poisoning and procedural complications SUBDURAL HAEMATOMA	1.4% 1/70 • Number of events 2 • From cycle 1 up to approximately 3 years
Investigations BLOOD CREATININE INCREASED	1.4% 1/70 • Number of events 1 • From cycle 1 up to approximately 3 years
Metabolism and nutrition disorders CACHEXIA	1.4% 1/70 • Number of events 1 • From cycle 1 up to approximately 3 years
Metabolism and nutrition disorders DIABETES MELLITUS INADEQUATE CONTROL	1.4% 1/70 • Number of events 1 • From cycle 1 up to approximately 3 years
Metabolism and nutrition disorders HYPERCALCAEMIA	1.4% 1/70 • Number of events 1 • From cycle 1 up to approximately 3 years
Metabolism and nutrition disorders HYPERGLYCAEMIA	1.4% 1/70 • Number of events 1 • From cycle 1 up to approximately 3 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTATIC NEOPLASM	1.4% 1/70 • Number of events 1 • From cycle 1 up to approximately 3 years
Nervous system disorders GENERALISED TONIC-CLONIC SEIZURE	2.9% 2/70 • Number of events 2 • From cycle 1 up to approximately 3 years
Nervous system disorders HYDROCEPHALUS	2.9% 2/70 • Number of events 2 • From cycle 1 up to approximately 3 years
Nervous system disorders SEIZURE	2.9% 2/70 • Number of events 2 • From cycle 1 up to approximately 3 years
Renal and urinary disorders ACUTE KIDNEY INJURY	2.9% 2/70 • Number of events 2 • From cycle 1 up to approximately 3 years
Reproductive system and breast disorders MENORRHAGIA	1.4% 1/70 • Number of events 1 • From cycle 1 up to approximately 3 years
Respiratory, thoracic and mediastinal disorders DYSPNOEA	2.9% 2/70 • Number of events 2 • From cycle 1 up to approximately 3 years
Respiratory, thoracic and mediastinal disorders EPISTAXIS	2.9% 2/70 • Number of events 2 • From cycle 1 up to approximately 3 years
Vascular disorders HYPOTENSION	1.4% 1/70 • Number of events 1 • From cycle 1 up to approximately 3 years

Other adverse events

Measure	Trastuzumab Emtansine n=70 participants at risk 3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.
Blood and lymphatic system disorders ANAEMIA	15.7% 11/70 • Number of events 11 • From cycle 1 up to approximately 3 years
Blood and lymphatic system disorders THROMBOCYTOPENIA	8.6% 6/70 • Number of events 11 • From cycle 1 up to approximately 3 years
Gastrointestinal disorders ABDOMINAL PAIN	8.6% 6/70 • Number of events 7 • From cycle 1 up to approximately 3 years
Gastrointestinal disorders DIARRHOEA	7.1% 5/70 • Number of events 7 • From cycle 1 up to approximately 3 years
Gastrointestinal disorders VOMITING	5.7% 4/70 • Number of events 4 • From cycle 1 up to approximately 3 years
General disorders ASTHENIA	11.4% 8/70 • Number of events 9 • From cycle 1 up to approximately 3 years
General disorders PAIN	11.4% 8/70 • Number of events 8 • From cycle 1 up to approximately 3 years
General disorders PYREXIA	27.1% 19/70 • Number of events 28 • From cycle 1 up to approximately 3 years
Investigations ALANINE AMINOTRANSFERASE INCREASED	7.1% 5/70 • Number of events 5 • From cycle 1 up to approximately 3 years
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	8.6% 6/70 • Number of events 8 • From cycle 1 up to approximately 3 years
Investigations HAEMOGLOBIN DECREASED	5.7% 4/70 • Number of events 9 • From cycle 1 up to approximately 3 years
Investigations PLATELET COUNT DECREASED	10.0% 7/70 • Number of events 9 • From cycle 1 up to approximately 3 years
Metabolism and nutrition disorders DECREASED APPETITE	5.7% 4/70 • Number of events 4 • From cycle 1 up to approximately 3 years
Metabolism and nutrition disorders HYPOMAGNESAEMIA	5.7% 4/70 • Number of events 4 • From cycle 1 up to approximately 3 years
Musculoskeletal and connective tissue disorders BACK PAIN	5.7% 4/70 • Number of events 8 • From cycle 1 up to approximately 3 years
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	5.7% 4/70 • Number of events 5 • From cycle 1 up to approximately 3 years
Nervous system disorders DIZZINESS	7.1% 5/70 • Number of events 7 • From cycle 1 up to approximately 3 years
Nervous system disorders HEADACHE	15.7% 11/70 • Number of events 13 • From cycle 1 up to approximately 3 years
Nervous system disorders NEUROPATHY PERIPHERAL	7.1% 5/70 • Number of events 5 • From cycle 1 up to approximately 3 years
Respiratory, thoracic and mediastinal disorders COUGH	11.4% 8/70 • Number of events 9 • From cycle 1 up to approximately 3 years
Respiratory, thoracic and mediastinal disorders EPISTAXIS	15.7% 11/70 • Number of events 14 • From cycle 1 up to approximately 3 years

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: genentech@druginfo.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER