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A Study of Trastuzumab Emtansine in Comparison With Treatment of Physician's Choice in Participants With HER2-positive Breast Cancer Who Have Received at Least Two Prior Regimens of HER2-directed Therapy (TH3RESA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01419197
First received: August 16, 2011
Last updated: August 17, 2016
Last verified: August 2016
Results First Received: February 7, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Trastuzumab emtansine
Drug: Treatment of physician's choice

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 602 patients were randomized to the study (404 to receive Trastuzumab Emtansine and 198 to receive Treatment of Physician’s Choice).

Reporting Groups
  Description
Trastuzumab Emtansine Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
Treatment of Physician’s Choice Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and human epidermal growth factor receptor 2 (HER2)-directed therapy.

Participant Flow:   Overall Study
    Trastuzumab Emtansine   Treatment of Physician’s Choice
STARTED   404   198 
Switched to Trastuzumab Emtansine   0   94 
COMPLETED   0   0 
NOT COMPLETED   404   198 
Death                247                122 
Physician Decision                4                4 
Non-compliance                3                1 
Withdrawal by Subject                33                32 
Study Completed by Sponsor                103                34 
Reason Not Specified                0                1 
Lost to Follow-up                14                4 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomized population: All participants who were randomized to the study.

Reporting Groups
  Description
Trastuzumab Emtansine Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
Treatment of Physician’s Choice Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
Total Total of all reporting groups

Baseline Measures
   Trastuzumab Emtansine   Treatment of Physician’s Choice   Total 
Overall Participants Analyzed 
[Units: Participants]
 404   198   602 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.3  (10.4)   54.3  (10.8)   53.6  (10.5) 
Gender 
[Units: Participants]
     
Female   401   197   598 
Male   3   1   4 


  Outcome Measures
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1.  Primary:   Progression-free Survival   [ Time Frame: Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years) ]

2.  Primary:   Overall Survival   [ Time Frame: Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years) ]

3.  Secondary:   Percentage of Participants With an Objective Response   [ Time Frame: Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years) ]

4.  Secondary:   Duration of the Objective Response   [ Time Frame: Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years) ]

5.  Secondary:   6-month and 1-year Survival   [ Time Frame: Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years) ]

6.  Secondary:   Time to Pain Symptom Progression   [ Time Frame: Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years) ]

7.  Secondary:   Change From Baseline in the EORTC QLQ-BM22 Pain Score on Day 1 of Each Cycle   [ Time Frame: Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years) ]

8.  Secondary:   Overall Survival (Final Analysis)   [ Time Frame: Baseline to the clinical cut-off date of 13 Feb 2015 (up to 4 years) ]

9.  Secondary:   6-month and 1-year Survival (Final Analysis)   [ Time Frame: Baseline to the clinical cut-off date of 13 Feb 2015 (up to 4 years) ]


  Serious Adverse Events
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Time Frame Adverse events were collected from treatment initiation until 30 days following the last administration of study drug or study discontinuation on 31 August 2015 (up to approximately 4 years).
Additional Description Safety population: All participants who received any amount of planned study treatment, according to treatment actually received. Data for participants in the Treatment of Physicians Choice (TPC) arm who switched treatment to receive trastuzumab emtansine (TE) following disease progression on TPC are presented separately. Median treatment duration of trastuzumab emtansine: 5.2 months (range 0.03-40.7),TPC: 2.7 months (range 0.03-31.0) and TE - Post TPC Treatment Switch: 4.5 months (range 1-43).

Reporting Groups
  Description
Trastuzumab Emtansine Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
Treatment of Physician’s Choice (TPC) Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
Trastuzumab Emtansine - Post TPC Treatment Switch Participants, who switched treatment in the Treatment of Physician's Choice arm to trastuzumab emtansine, were administered trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.

Serious Adverse Events
    Trastuzumab Emtansine   Treatment of Physician’s Choice (TPC)   Trastuzumab Emtansine - Post TPC Treatment Switch
Total, serious adverse events       
# participants affected / at risk   102/403 (25.31%)   41/184 (22.28%)   19/94 (20.21%) 
Blood and lymphatic system disorders       
Anaemia † 1       
# participants affected / at risk   1/403 (0.25%)   2/184 (1.09%)   1/94 (1.06%) 
Febrile neutropenia † 1       
# participants affected / at risk   1/403 (0.25%)   7/184 (3.80%)   0/94 (0.00%) 
Granulocytopenia † 1       
# participants affected / at risk   0/403 (0.00%)   1/184 (0.54%)   0/94 (0.00%) 
Neutropenia † 1       
# participants affected / at risk   1/403 (0.25%)   2/184 (1.09%)   0/94 (0.00%) 
Thrombocytopenia † 1       
# participants affected / at risk   1/403 (0.25%)   1/184 (0.54%)   0/94 (0.00%) 
Cardiac disorders       
Cardiac failure † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Ear and labyrinth disorders       
Vertigo † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Endocrine disorders       
Hypercalcaemia of malignancy † 1       
# participants affected / at risk   0/403 (0.00%)   1/184 (0.54%)   0/94 (0.00%) 
Eye disorders       
Vision blurred † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Gastrointestinal disorders       
Abdominal discomfort † 1       
# participants affected / at risk   0/403 (0.00%)   1/184 (0.54%)   0/94 (0.00%) 
Abdominal pain † 1       
# participants affected / at risk   4/403 (0.99%)   3/184 (1.63%)   1/94 (1.06%) 
Abdominal pain upper † 1       
# participants affected / at risk   0/403 (0.00%)   1/184 (0.54%)   0/94 (0.00%) 
Abdominal wall haematoma † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Colitis † 1       
# participants affected / at risk   2/403 (0.50%)   0/184 (0.00%)   0/94 (0.00%) 
Diarrhoea † 1       
# participants affected / at risk   2/403 (0.50%)   1/184 (0.54%)   0/94 (0.00%) 
Gastric haemorrhage † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Ileus † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Nausea † 1       
# participants affected / at risk   0/403 (0.00%)   2/184 (1.09%)   0/94 (0.00%) 
Obstruction gastric † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Pancreatitis † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Proctitis Haemorrhagic † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Small intestinal obstruction † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Upper gastrointestinal haemorrhage † 1       
# participants affected / at risk   0/403 (0.00%)   1/184 (0.54%)   1/94 (1.06%) 
Vomiting † 1       
# participants affected / at risk   2/403 (0.50%)   2/184 (1.09%)   0/94 (0.00%) 
General disorders       
Adverse drug reaction † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Asthenia † 1       
# participants affected / at risk   3/403 (0.74%)   0/184 (0.00%)   0/94 (0.00%) 
Death † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Device occlusion † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Fatigue † 1       
# participants affected / at risk   1/403 (0.25%)   1/184 (0.54%)   0/94 (0.00%) 
General physical health deterioration † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Malaise † 1       
# participants affected / at risk   2/403 (0.50%)   0/184 (0.00%)   0/94 (0.00%) 
Non-cardiac chest pain † 1       
# participants affected / at risk   0/403 (0.00%)   1/184 (0.54%)   0/94 (0.00%) 
Oedema peripheral † 1       
# participants affected / at risk   2/403 (0.50%)   2/184 (1.09%)   0/94 (0.00%) 
Pain † 1       
# participants affected / at risk   0/403 (0.00%)   1/184 (0.54%)   0/94 (0.00%) 
Pyrexia † 1       
# participants affected / at risk   7/403 (1.74%)   2/184 (1.09%)   1/94 (1.06%) 
Vessel puncture site haemorrhage † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Hepatobiliary disorders       
Bile duct obstruction † 1       
# participants affected / at risk   1/403 (0.25%)   1/184 (0.54%)   0/94 (0.00%) 
Cholangitis † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Cholecystitis † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Nodular regenerative hyperplasia † 1       
# participants affected / at risk   3/403 (0.74%)   0/184 (0.00%)   0/94 (0.00%) 
Hepatotoxicity † 1       
# participants affected / at risk   0/403 (0.00%)   0/184 (0.00%)   1/94 (1.06%) 
Immune system disorders       
Drug hypersensitivity † 1       
# participants affected / at risk   0/403 (0.00%)   1/184 (0.54%)   0/94 (0.00%) 
Hypersensitivity † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   1/94 (1.06%) 
Infections and infestations       
Appendicitis † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Bronchopneumonia † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Cellulitis † 1       
# participants affected / at risk   2/403 (0.50%)   4/184 (2.17%)   1/94 (1.06%) 
Clostridium bacteraemia † 1       
# participants affected / at risk   0/403 (0.00%)   1/184 (0.54%)   0/94 (0.00%) 
Device related infection † 1       
# participants affected / at risk   1/403 (0.25%)   1/184 (0.54%)   0/94 (0.00%) 
Device related sepsis † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Gastroenteritis † 1       
# participants affected / at risk   2/403 (0.50%)   0/184 (0.00%)   0/94 (0.00%) 
Infected fistula † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Infection † 1       
# participants affected / at risk   2/403 (0.50%)   0/184 (0.00%)   0/94 (0.00%) 
Infectious colitis † 1       
# participants affected / at risk   0/403 (0.00%)   1/184 (0.54%)   0/94 (0.00%) 
Lung infection † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   1/94 (1.06%) 
Lymphangitis † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Mastitis † 1       
# participants affected / at risk   0/403 (0.00%)   1/184 (0.54%)   0/94 (0.00%) 
Neutropenic sepsis † 1       
# participants affected / at risk   0/403 (0.00%)   1/184 (0.54%)   0/94 (0.00%) 
Pharyngotonsillitis † 1       
# participants affected / at risk   0/403 (0.00%)   1/184 (0.54%)   0/94 (0.00%) 
Pneumonia † 1       
# participants affected / at risk   5/403 (1.24%)   0/184 (0.00%)   1/94 (1.06%) 
Postoperative wound infection † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Sepsis † 1       
# participants affected / at risk   3/403 (0.74%)   0/184 (0.00%)   0/94 (0.00%) 
Sinusitis † 1       
# participants affected / at risk   1/403 (0.25%)   1/184 (0.54%)   0/94 (0.00%) 
Tracheitis † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Upper respiratory tract infection † 1       
# participants affected / at risk   2/403 (0.50%)   0/184 (0.00%)   0/94 (0.00%) 
Urinary tract infection † 1       
# participants affected / at risk   4/403 (0.99%)   0/184 (0.00%)   0/94 (0.00%) 
Urosepsis † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Viral upper respiratory tract infection † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Wound infection † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Abdominal infection † 1       
# participants affected / at risk   0/403 (0.00%)   0/184 (0.00%)   1/94 (1.06%) 
Abscess † 1       
# participants affected / at risk   0/403 (0.00%)   0/184 (0.00%)   1/94 (1.06%) 
Biliary tract infection † 1       
# participants affected / at risk   0/403 (0.00%)   0/184 (0.00%)   1/94 (1.06%) 
Injury, poisoning and procedural complications       
Fall † 1       
# participants affected / at risk   2/403 (0.50%)   0/184 (0.00%)   0/94 (0.00%) 
Femoral neck fracture † 1       
# participants affected / at risk   2/403 (0.50%)   0/184 (0.00%)   0/94 (0.00%) 
Femur fracture † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Infusion related reaction † 1       
# participants affected / at risk   1/403 (0.25%)   1/184 (0.54%)   0/94 (0.00%) 
Sternal fracture † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Subdural haematoma † 1       
# participants affected / at risk   2/403 (0.50%)   0/184 (0.00%)   0/94 (0.00%) 
Subdural haemorrhage † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Thoracic vertebral fracture † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Traumatic intracranial haemorrhage † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Wound decomposition † 1       
# participants affected / at risk   0/403 (0.00%)   1/184 (0.54%)   0/94 (0.00%) 
Wound haemorrhage † 1       
# participants affected / at risk   1/403 (0.25%)   1/184 (0.54%)   0/94 (0.00%) 
Toxicity to various agents † 1       
# participants affected / at risk   0/403 (0.00%)   0/184 (0.00%)   1/94 (1.06%) 
Upper limb fracture † 1       
# participants affected / at risk   0/403 (0.00%)   0/184 (0.00%)   1/94 (1.06%) 
Investigations       
Transaminases increased † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
White blood cell count decreased † 1       
# participants affected / at risk   0/403 (0.00%)   1/184 (0.54%)   0/94 (0.00%) 
Metabolism and nutrition disorders       
Decreased appetite † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   1/94 (1.06%) 
Dehydration † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Hypercalcaemia † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Hyperglycaemia † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Hypokalaemia † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Hyponatraemia † 1       
# participants affected / at risk   4/403 (0.99%)   0/184 (0.00%)   0/94 (0.00%) 
Hypophagia † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Malnutrition † 1       
# participants affected / at risk   0/403 (0.00%)   1/184 (0.54%)   0/94 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Back pain † 1       
# participants affected / at risk   2/403 (0.50%)   0/184 (0.00%)   0/94 (0.00%) 
Bone pain † 1       
# participants affected / at risk   0/403 (0.00%)   1/184 (0.54%)   0/94 (0.00%) 
Muscle haemorrhage † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Musculoskeletal chest pain † 1       
# participants affected / at risk   1/403 (0.25%)   1/184 (0.54%)   0/94 (0.00%) 
Myalgia † 1       
# participants affected / at risk   0/403 (0.00%)   1/184 (0.54%)   0/94 (0.00%) 
Spinal pain † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Muscular weakness † 1       
# participants affected / at risk   0/403 (0.00%)   0/184 (0.00%)   1/94 (1.06%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Rectal adenocarcinoma † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Tumour haemorrhage † 1       
# participants affected / at risk   2/403 (0.50%)   0/184 (0.00%)   0/94 (0.00%) 
Tumor pain † 1       
# participants affected / at risk   0/403 (0.00%)   1/184 (0.54%)   0/94 (0.00%) 
Tumour necrosis † 1       
# participants affected / at risk   0/403 (0.00%)   0/184 (0.00%)   1/94 (1.06%) 
Nervous system disorders       
Ataxia † 1       
# participants affected / at risk   1/403 (0.25%)   1/184 (0.54%)   0/94 (0.00%) 
Brain oedema † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Cerebral haematoma † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Cerebral haemorrhage † 1       
# participants affected / at risk   2/403 (0.50%)   0/184 (0.00%)   0/94 (0.00%) 
Cognitive disorder † 1       
# participants affected / at risk   0/403 (0.00%)   1/184 (0.54%)   0/94 (0.00%) 
Depressed level of consciousness † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Dizziness † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Haemorrhage intracranial † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Hepatic encephalopathy † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Loss of consciousness † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Paraesthesia † 1       
# participants affected / at risk   0/403 (0.00%)   1/184 (0.54%)   0/94 (0.00%) 
Paraparesis † 1       
# participants affected / at risk   0/403 (0.00%)   1/184 (0.54%)   0/94 (0.00%) 
Seizure † 1       
# participants affected / at risk   5/403 (1.24%)   0/184 (0.00%)   1/94 (1.06%) 
Somnolence † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Subarachnoid haemorrhage † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Transient ischaemic attack † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Visual field defect † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Epilepsy † 1       
# participants affected / at risk   0/403 (0.00%)   0/184 (0.00%)   1/94 (1.06%) 
Hemiplegia † 1       
# participants affected / at risk   0/403 (0.00%)   0/184 (0.00%)   1/94 (1.06%) 
Psychiatric disorders       
Confusional state † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Renal and urinary disorders       
Haematuria † 1       
# participants affected / at risk   1/403 (0.25%)   1/184 (0.54%)   0/94 (0.00%) 
Reproductive system and breast disorders       
Vaginal haemorrhage † 1       
# participants affected / at risk   2/403 (0.50%)   0/184 (0.00%)   0/94 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea † 1       
# participants affected / at risk   6/403 (1.49%)   5/184 (2.72%)   2/94 (2.13%) 
Epistaxis † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Haemoptysis † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Non-cardiogenic pulmonary oedema † 1       
# participants affected / at risk   0/403 (0.00%)   1/184 (0.54%)   0/94 (0.00%) 
Obliterative bronchiolitis † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Pleural effusion † 1       
# participants affected / at risk   3/403 (0.74%)   2/184 (1.09%)   0/94 (0.00%) 
Pleuritic pain † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Pneumonia aspiration † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Pneumonitis † 1       
# participants affected / at risk   2/403 (0.50%)   1/184 (0.54%)   0/94 (0.00%) 
Pneumothorax † 1       
# participants affected / at risk   1/403 (0.25%)   1/184 (0.54%)   0/94 (0.00%) 
Pulmonary embolism † 1       
# participants affected / at risk   1/403 (0.25%)   2/184 (1.09%)   1/94 (1.06%) 
Respiratory failure † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Pulmonary Fibrosis † 1       
# participants affected / at risk   0/403 (0.00%)   0/184 (0.00%)   1/94 (1.06%) 
Vascular disorders       
Deep vein thrombosis † 1       
# participants affected / at risk   2/403 (0.50%)   0/184 (0.00%)   0/94 (0.00%) 
Embolism † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Embolism venous † 1       
# participants affected / at risk   0/403 (0.00%)   1/184 (0.54%)   0/94 (0.00%) 
Hypertensive crisis † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Hypotension † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Lymphoedema † 1       
# participants affected / at risk   0/403 (0.00%)   1/184 (0.54%)   1/94 (1.06%) 
Superior vena cava syndrome † 1       
# participants affected / at risk   1/403 (0.25%)   0/184 (0.00%)   0/94 (0.00%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (16.0)




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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800 821-8590


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01419197     History of Changes
Other Study ID Numbers: TDM4997g
BO25734 ( Other Identifier: Hoffmann-La Roche )
2011-000509-29 ( EudraCT Number )
Study First Received: August 16, 2011
Results First Received: February 7, 2014
Last Updated: August 17, 2016
Health Authority: United States: Food and Drug Administration