Trial Outcomes & Findings for Multicenter Evaluation of Docetaxel, Gemcitabine, and Bevacizumab Combination Followed by Bevacizumab Alone in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NCT NCT00378573)

NCT ID: NCT00378573

Last Updated: 2010-01-26

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 17 participants
• Primary outcome timeframe: 1 year post-registration
• Results posted on: 2010-01-26

Participant Flow

Participant milestones

Measure	Docetaxel, Gemcitabine and Bevacizumab Combination therapy administered as follows: gemcitabine 1000 mg/m2 IV over 0.5 hour on Days 1 and 8; docetaxel 75 mg/m2 IV over 1 hour on Day 8; and bevacizumab 15 mg/kg IV on Day 1. Maintenance bevacizumab therapy was administered as 15 mg/kg IV on Day 1.
Treatment Period STARTED	17
Treatment Period COMPLETED	0
Treatment Period NOT COMPLETED	17
Follow-up STARTED	17
Follow-up COMPLETED	3
Follow-up NOT COMPLETED	14

Reasons for withdrawal

Measure	Docetaxel, Gemcitabine and Bevacizumab Combination therapy administered as follows: gemcitabine 1000 mg/m2 IV over 0.5 hour on Days 1 and 8; docetaxel 75 mg/m2 IV over 1 hour on Day 8; and bevacizumab 15 mg/kg IV on Day 1. Maintenance bevacizumab therapy was administered as 15 mg/kg IV on Day 1.
Treatment Period Adverse Event	9
Treatment Period Physician Decision	1
Treatment Period Withdrawal by Subject	2
Treatment Period Disease Progression	4
Treatment Period Sponsor decision to close study	1
Follow-up Death	12
Follow-up Lost to Follow-up	1
Follow-up Withdrawal by Subject	1

Baseline Characteristics

Multicenter Evaluation of Docetaxel, Gemcitabine, and Bevacizumab Combination Followed by Bevacizumab Alone in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Measure	Docetaxel, Gemcitabine and Bevacizumab n=17 Participants Combination therapy administered as follows: gemcitabine 1000 mg/m2 IV over 0.5 hour on Days 1 and 8; docetaxel 75 mg/m2 IV over 1 hour on Day 8; and bevacizumab 15 mg/kg IV on Day 1. Maintenance bevacizumab therapy was administered as 15 mg/kg IV on Day 1.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age Continuous	64.1 years STANDARD_DEVIATION 11.74 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment USA	17 Participants n=5 Participants
Disease Stage at 1st diagnosis IA	0 Participants n=5 Participants
Disease Stage at 1st diagnosis IB	0 Participants n=5 Participants
Disease Stage at 1st diagnosis IIA	0 Participants n=5 Participants
Disease Stage at 1st diagnosis IIB	1 Participants n=5 Participants
Disease Stage at 1st diagnosis IIIA	0 Participants n=5 Participants
Disease Stage at 1st diagnosis IIIB	2 Participants n=5 Participants
Disease Stage at 1st diagnosis IV	14 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - Fully Active	7 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 1 - Ambulatory, Restricted Activity	8 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 2 - Ambulatory, No Work Activities	2 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 3 - Limited Self Care, Partly Confined To Bed	0 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 4 - Completely Disabled, No Self Care	0 Participants n=5 Participants
Histopathological Grade G1 (well differentiated)	1 Participants n=5 Participants
Histopathological Grade G2 (moderately differentiated)	3 Participants n=5 Participants
Histopathological Grade G3 (poorly differentiated)	3 Participants n=5 Participants
Histopathological Grade G4 (undifferentiated)	1 Participants n=5 Participants
Histopathological Grade Unknown	9 Participants n=5 Participants
Tumor Histology Adenocarcinoma	15 Participants n=5 Participants
Tumor Histology Bronchoalveolar Cell	1 Participants n=5 Participants
Tumor Histology Large Cell	1 Participants n=5 Participants
Body Surface Area (BSA)	1.766 m² STANDARD_DEVIATION 0.1737 • n=5 Participants
Weight	68.22 kg STANDARD_DEVIATION 12.648 • n=5 Participants

PRIMARY outcome

Timeframe: 1 year post-registration

Population: Due to early termination of the study only 17/90 subjects enrolled. Efficacy analysis of Progression Free Survival and Overall Survival were not performed. Efficacy results limited to a descriptive summary of best overall response for each subject.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year from start of treatment

Population: Due to early termination of the study only 17/90 subjects enrolled. Efficacy analysis of Progression Free Survival and Overall Survival were not performed. Efficacy results limited to a descriptive summary of best overall response for each subject.

Complete response is defined as disappearance of all target and nontarget lesions identified and reported at baseline (at or within 4 weeks before the beginning of treatment) by image-based evaluations such as computerized tomography (CT) or magnetic resonance imaging (MRI).

Partial response is defined as persistence of one or more nontarget lesions and at least 30 percent decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.

Outcome measures

Measure	Docetaxel, Gemcitabine and Bevacizumab n=17 Participants Combination therapy administered as follows: gemcitabine 1000 mg/m2 IV over 0.5 hour on Days 1 and 8; docetaxel 75 mg/m2 IV over 1 hour on Day 8; and bevacizumab 15 mg/kg IV on Day 1. Maintenance bevacizumab therapy was administered as 15 mg/kg IV on Day 1.
Objective Response Rate (Complete Response [CR] Plus Partial Response [PR]) Using Response Evaluation Criteria in Solid Tumors (RECIST) Complete Response	0 Participants
Objective Response Rate (Complete Response [CR] Plus Partial Response [PR]) Using Response Evaluation Criteria in Solid Tumors (RECIST) Confirmed Partial Response	6 Participants
Objective Response Rate (Complete Response [CR] Plus Partial Response [PR]) Using Response Evaluation Criteria in Solid Tumors (RECIST) Unconfirmed Partial Response	1 Participants
Objective Response Rate (Complete Response [CR] Plus Partial Response [PR]) Using Response Evaluation Criteria in Solid Tumors (RECIST) Stable Disease	2 Participants
Objective Response Rate (Complete Response [CR] Plus Partial Response [PR]) Using Response Evaluation Criteria in Solid Tumors (RECIST) Progressive Disease	7 Participants
Objective Response Rate (Complete Response [CR] Plus Partial Response [PR]) Using Response Evaluation Criteria in Solid Tumors (RECIST) Not Evaluable	1 Participants

SECONDARY outcome

Timeframe: 2 years post-registration

Population: Due to early termination of the study only 17/90 subjects enrolled. Efficacy analysis of Progression Free Survival and Overall Survival were not performed. Efficacy results limited to a descriptive summary of best overall response for each subject.

Survival is defined as the time from the date of registration to the study to the date of death.

Outcome measures

Outcome data not reported

Adverse Events

Docetaxel, Gemcitabine and Bevacizumab

Serious events: 9 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Measure	Docetaxel, Gemcitabine and Bevacizumab n=17 participants at risk Combination therapy administered as follows: gemcitabine 1000 mg/m2 IV over 0.5 hour on Days 1 and 8; docetaxel 75 mg/m2 IV over 1 hour on Day 8; and bevacizumab 15 mg/kg IV on Day 1. Maintenance bevacizumab therapy was administered as 15 mg/kg IV on Day 1.
Gastrointestinal disorders Intestinal Perforation	11.8% 2/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Gastrointestinal disorders Dysphagia	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Gastrointestinal disorders Gastrointestinal Perforation	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Gastrointestinal disorders Vomiting	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Vascular disorders Deep Vein Thrombosis	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Vascular disorders Hypertensive Crisis	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Vascular disorders Jugular Vein Thrombosis	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Cardiac disorders Atrial Fibrilation	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Cardiac disorders Cardiac Failure Congestive	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Small Cell Lung Cancer	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Small Cell Lung Cancer Metastatic	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Respiratory, thoracic and mediastinal disorders Haemoptysis	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Respiratory, thoracic and mediastinal disorders Interstitial Lung Disease	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Blood and lymphatic system disorders Febrile Neutropenia	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Infections and infestations Lobar Pneumonia	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Investigations Weight Decreased	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Musculoskeletal and connective tissue disorders Arthralgia	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug

Other adverse events

Measure	Docetaxel, Gemcitabine and Bevacizumab n=17 participants at risk Combination therapy administered as follows: gemcitabine 1000 mg/m2 IV over 0.5 hour on Days 1 and 8; docetaxel 75 mg/m2 IV over 1 hour on Day 8; and bevacizumab 15 mg/kg IV on Day 1. Maintenance bevacizumab therapy was administered as 15 mg/kg IV on Day 1.
General disorders Fatigue	52.9% 9/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
General disorders Oedema Peripheral	47.1% 8/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
General disorders Mucosal inflammation	41.2% 7/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
General disorders Asthenia	23.5% 4/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
General disorders Chills	17.6% 3/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
General disorders Pyrexia	17.6% 3/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
General disorders Non-Cardiac Chest Pain	11.8% 2/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
General disorders Catheter Site Pain	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
General disorders Infusion Related Reaction	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
General disorders Infusion Site Inflammation	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
General disorders Injection Site Reaction	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Gastrointestinal disorders Diarrhoea	41.2% 7/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Gastrointestinal disorders Constipation	35.3% 6/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Gastrointestinal disorders Nausea	35.3% 6/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Gastrointestinal disorders Stomatitis	23.5% 4/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Gastrointestinal disorders Dry Mouth	11.8% 2/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Gastrointestinal disorders Vomiting	11.8% 2/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Gastrointestinal disorders Abdominal Discomfort	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Gastrointestinal disorders Abdominal Pain	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Gastrointestinal disorders Dysphagia	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Gastrointestinal disorders Proctalgia	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Gastrointestinal disorders Rectal Harmorrhage	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Gastrointestinal disorders Tongue Ulceration	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Respiratory, thoracic and mediastinal disorders Cough	47.1% 8/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Respiratory, thoracic and mediastinal disorders Dysphonia	17.6% 3/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Respiratory, thoracic and mediastinal disorders Dyspnoea	17.6% 3/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Respiratory, thoracic and mediastinal disorders Epistaxis	17.6% 3/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	11.8% 2/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Respiratory, thoracic and mediastinal disorders Atelectasis	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Respiratory, thoracic and mediastinal disorders Bronchitis Chronic	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Respiratory, thoracic and mediastinal disorders Hiccup	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Respiratory, thoracic and mediastinal disorders Nasal Ulcer	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal Pain	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Respiratory, thoracic and mediastinal disorders Sinus Congestion	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Blood and lymphatic system disorders Anaemia	47.1% 8/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Blood and lymphatic system disorders Neutropenia	17.6% 3/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Blood and lymphatic system disorders Thrombocytopenia	17.6% 3/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Blood and lymphatic system disorders Leukopenia	11.8% 2/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Blood and lymphatic system disorders Bone Marrow Failure	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Blood and lymphatic system disorders Febrile Neutropenia	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Blood and lymphatic system disorders Granulocytopenia	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Metabolism and nutrition disorders Anorexia	23.5% 4/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Metabolism and nutrition disorders Hypokalaemia	17.6% 3/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Metabolism and nutrition disorders Dehydration	11.8% 2/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Metabolism and nutrition disorders Hyponatraemia	11.8% 2/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Metabolism and nutrition disorders Fluid Overload	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Metabolism and nutrition disorders Hyperglycaemia	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Metabolism and nutrition disorders Hypomagnesaemia	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Musculoskeletal and connective tissue disorders Pain in Extremity	17.6% 3/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Musculoskeletal and connective tissue disorders Back Pain	11.8% 2/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Musculoskeletal and connective tissue disorders Arthralgia	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Musculoskeletal and connective tissue disorders Muscular Weakness	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Musculoskeletal and connective tissue disorders Muskuloskeletal Chest Pain	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Musculoskeletal and connective tissue disorders Myalgia	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Skin and subcutaneous tissue disorders Alopecia	23.5% 4/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Skin and subcutaneous tissue disorders Rash	23.5% 4/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Skin and subcutaneous tissue disorders Decubitus Ulcer	11.8% 2/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Skin and subcutaneous tissue disorders Dry Skin	11.8% 2/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Skin and subcutaneous tissue disorders Erythema	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Skin and subcutaneous tissue disorders Nail Discoloration	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Skin and subcutaneous tissue disorders Petechiae	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Skin and subcutaneous tissue disorders Pruritus	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Skin and subcutaneous tissue disorders Skin Exfoliation	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Skin and subcutaneous tissue disorders Skin Hyperpigmentation	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Infections and infestations Bronchitis	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Infections and infestations Candidiasis	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Infections and infestations Catheter Related Infection	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Infections and infestations Catheter Site infection	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Infections and infestations Cellulitis	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Infections and infestations Lobar Pneumonia	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Infections and infestations Oesophageal Candidiasis	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Infections and infestations Pneumonia	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Infections and infestations Staphylococcal Infection	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Infections and infestations Upper Respiratory Tract Infection	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Infections and infestations Urinary Tract Infection	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Nervous system disorders Dizziness	17.6% 3/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Nervous system disorders Hypoaesthesia	11.8% 2/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Nervous system disorders Dysgeusia	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Nervous system disorders Headache	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Nervous system disorders Paraesthesia	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Nervous system disorders Syncope	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Psychiatric disorders Anxiety	11.8% 2/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Psychiatric disorders Depression	11.8% 2/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Psychiatric disorders Insomnia	11.8% 2/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Psychiatric disorders Delusion	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Injury, poisoning and procedural complications Excoriation	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Injury, poisoning and procedural complications Insision Site Complication	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Injury, poisoning and procedural complications Procedural Pain	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Injury, poisoning and procedural complications Radiation Oesophagitis	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Injury, poisoning and procedural complications Wound Dehiscence	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Investigations Weight Decreased	11.8% 2/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Investigations Haemoglobin Decreased	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Investigations Neutrophil Count Decreased	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Cardiac disorders Atrial Fibrilation	11.8% 2/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Cardiac disorders Atrial Flutter	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Cardiac disorders Supraventricular Tachycardia	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Vascular disorders Deep Vein Thrombosis	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Vascular disorders Phlebitis Superficial	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Eye disorders Diplopia	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Immune system disorders Drug Hypersensitivity	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug
Renal and urinary disorders Urinary Retention	5.9% 1/17 • Adverse Events were collected from time of subject consent until 30 days after the completion of the last dose of study drug

Additional Information

Medical Affairs study director

sanofi-aventis

Email: publicregistryUSMA@sanofi-aventis.com

Results disclosure agreements

• Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
• Publication restrictions are in place

Restriction type: OTHER