Trial Outcomes & Findings for Docetaxel & Oxaliplatin in Combination With Bevacizumab as First-Line Treatment in Subjects With Non-Small Cell Lung Cancer (NSCLC) (NCT NCT00356122)

Last Updated: 2011-10-17

Results Overview

PFS was defined as the interval from the date of registration to the earliest date of documented evidence of progressive disease, or the date of death due to any cause, whichever occurred first. Progressive disease occurred when the participant had at least a 20% increase in the sum of the longest diameter (LD) of target lesions, compared to the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

53 participants

Primary outcome timeframe

Baseline to PFS (up to 24 months after the first treatment)

Results posted on

2011-10-17

Participant Flow

The study was initiated in 18 sites in the United States, of which 14 sites enrolled a total of 85 participants.

Of the 85 participants screened for this study, 32 were screen-failures. 53 participants were registered to receive treatment in this study, however, one participant did not receive any study medication. All 53 participants entered the follow-up period, even if they discontinued treatment.

Participant milestones

Participant milestones
Measure	Docetaxel/Oxaliplatin/Bevacizumab Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of * 70 mg/m\^2 docetaxel intravenously on Day 1 for Cycles 1-6, * 100 mg/m\^2 oxaliplatin intravenously on Day 1 for Cycles 1-6, * 15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy.
TREATMENT STARTED	53
TREATMENT COMPLETED	8
TREATMENT NOT COMPLETED	45
FOLLOW-UP STARTED	53
FOLLOW-UP COMPLETED	12
FOLLOW-UP NOT COMPLETED	41

Reasons for withdrawal

Reasons for withdrawal
Measure	Docetaxel/Oxaliplatin/Bevacizumab Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of * 70 mg/m\^2 docetaxel intravenously on Day 1 for Cycles 1-6, * 100 mg/m\^2 oxaliplatin intravenously on Day 1 for Cycles 1-6, * 15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy.
TREATMENT Lack of Efficacy	26
TREATMENT Adverse Event	10
TREATMENT Subject's request	4
TREATMENT Other	4
TREATMENT Did not receive study medication	1
FOLLOW-UP Death	37
FOLLOW-UP Lost to Follow-up	2
FOLLOW-UP Other	2

Baseline Characteristics

Docetaxel & Oxaliplatin in Combination With Bevacizumab as First-Line Treatment in Subjects With Non-Small Cell Lung Cancer (NSCLC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Docetaxel/Oxaliplatin/Bevacizumab n=53 Participants Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of * 70 mg/m\^2 docetaxel intravenously on Day 1 for Cycles 1-6, * 100 mg/m\^2 oxaliplatin intravenously on Day 1 for Cycles 1-6, * 15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy.
Age Continuous	61.10 years STANDARD_DEVIATION 11.07 • n=5 Participants
Age, Customized <65 years	28 participants n=5 Participants
Age, Customized >=65 years	25 participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants
Weight	76.530 kilograms STANDARD_DEVIATION 17.793 • n=5 Participants
Height	169.80 Centimeters STANDARD_DEVIATION 9.57 • n=5 Participants
Body Surface Area (BSA)	1.875 Square meters STANDARD_DEVIATION 0.252 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to PFS (up to 24 months after the first treatment)

Population: All participants registered to receive study treatment

Outcome measures

Outcome measures
Measure	Docetaxel/Oxaliplatin/Bevacizumab n=53 Participants Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of * 70 mg/m\^2 docetaxel intravenously on Day 1 for Cycles 1-6, * 100 mg/m\^2 oxaliplatin intravenously on Day 1 for Cycles 1-6, * 15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy.
Progression-free Survival (PFS)	5.6 Months Interval 3.7 to 7.6

SECONDARY outcome

Timeframe: Baseline to CR or PR (up to 24 months after the first treatment)

Population: All participants registered to receive study treatment

Objective response rate is the percentage of participants with an objective response. Improvements in tumor measurements from baseline values were assigned a status of Complete Response (CR) or Partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST). Overall objective response was the sum of CR and PR. CR referred to the disappearance of all target lesions, and PR was at least 30% decrease in the sum of the longest diameter (LD) of target lesions, compared to the baseline sum LD. Responses were confirmed by repeat assessments within 4 to 6 weeks.

Outcome measures

Outcome measures
Measure	Docetaxel/Oxaliplatin/Bevacizumab n=53 Participants Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of * 70 mg/m\^2 docetaxel intravenously on Day 1 for Cycles 1-6, * 100 mg/m\^2 oxaliplatin intravenously on Day 1 for Cycles 1-6, * 15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy.
Objective Response Rate	30.2 Percentage of participants Interval 18.3 to 44.3

SECONDARY outcome

Timeframe: Baseline to treatment failure (up to 24 months after the first treatment)

Population: All participants registered to receive study treatment

Treatment failure was defined as an event which lead to the participant's withdrawal from the study treatment due to lack of efficacy, disease progression, adverse events, or due to a participant's request as recorded in the Case Report Form (CRF), death, or use of other anticancer therapy. TTF was assessed using Kaplan-Meier method, and the median TTF with 95% CIs was computed using the Brookmeyer and Crowley method.

Outcome measures

Outcome measures
Measure	Docetaxel/Oxaliplatin/Bevacizumab n=53 Participants Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of * 70 mg/m\^2 docetaxel intravenously on Day 1 for Cycles 1-6, * 100 mg/m\^2 oxaliplatin intravenously on Day 1 for Cycles 1-6, * 15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy.
Time-to-treatment Failure (TTF)	4.7 Months Interval 2.9 to 5.6

SECONDARY outcome

Timeframe: Baseline to OS (up to 24 months after the first treatment)

Population: All participants registered to receive study treatment

OS was measured from the date of registration to the date of death due to any cause, or to the date of last contact (for censored observations). OS was assessed by the Kaplan-Meier method and the estimates of median survival time with 95% CI are reported.

Outcome measures

Outcome measures
Measure	Docetaxel/Oxaliplatin/Bevacizumab n=53 Participants Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of * 70 mg/m\^2 docetaxel intravenously on Day 1 for Cycles 1-6, * 100 mg/m\^2 oxaliplatin intravenously on Day 1 for Cycles 1-6, * 15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy.
Overall Survival (OS)	14.0 Months Interval 9.9 to 16.9

SECONDARY outcome

Timeframe: From baseline up to 30 days after treatment discontinuation

Population: All participants who received at least one dose of study treatment

Treatment-related toxicities were serious and non-serious adverse events (AE) considered related to study treatment by the investigator. AEs were any unfavorable and unintended signs, symptoms, syndromes, or illnesses that developed or worsened during the observation period, and included abnormal results from diagnostic procedures. Serious AEs resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability or incapacity, appeared as a congenital anomaly or were considered medically important by the investigator.

Outcome measures

Outcome measures
Measure	Docetaxel/Oxaliplatin/Bevacizumab n=52 Participants Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of * 70 mg/m\^2 docetaxel intravenously on Day 1 for Cycles 1-6, * 100 mg/m\^2 oxaliplatin intravenously on Day 1 for Cycles 1-6, * 15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy.
Number of Participants With Treatment-related Toxicities At least one AE related to docetaxel	51 Participants
Number of Participants With Treatment-related Toxicities At least one AE related to oxaliplatin	50 Participants
Number of Participants With Treatment-related Toxicities At least one AE related to bevacizumab	43 Participants

Adverse Events

Docetaxel/Oxaliplatin/Bevacizumab

Serious events: 17 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Docetaxel/Oxaliplatin/Bevacizumab n=52 participants at risk Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of * 70 mg/m\^2 docetaxel intravenously on Day 1 for Cycles 1-6, * 100 mg/m\^2 oxaliplatin intravenously on Day 1 for Cycles 1-6, * 15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	3.8% 2/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Cardiac disorders SUPRAVENTRICULAR TACHYCARDIA	3.8% 2/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Cardiac disorders ATRIAL FIBRILLATION	1.9% 1/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Gastrointestinal disorders ABDOMINAL PAIN	5.8% 3/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Gastrointestinal disorders DIARRHOEA	3.8% 2/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Gastrointestinal disorders INTESTINAL PERFORATION	1.9% 1/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Gastrointestinal disorders LARGE INTESTINE PERFORATION	1.9% 1/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Gastrointestinal disorders VOMITING	1.9% 1/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
General disorders PYREXIA	1.9% 1/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Infections and infestations PNEUMONIA	7.7% 4/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Infections and infestations SEPSIS	3.8% 2/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Infections and infestations APPENDICITIS	1.9% 1/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Infections and infestations PSEUDOMONAL SEPSIS	1.9% 1/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Injury, poisoning and procedural complications WRONG DRUG ADMINISTERED	1.9% 1/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Metabolism and nutrition disorders DEHYDRATION	3.8% 2/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Metabolism and nutrition disorders HYPONATRAEMIA	1.9% 1/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Musculoskeletal and connective tissue disorders ARTHRALGIA	1.9% 1/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Musculoskeletal and connective tissue disorders PATHOLOGICAL FRACTURE	1.9% 1/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NON-SMALL CELL LUNG CANCER METASTATIC	1.9% 1/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Nervous system disorders SPINAL CORD COMPRESSION	1.9% 1/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Renal and urinary disorders RENAL FAILURE ACUTE	1.9% 1/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Respiratory, thoracic and mediastinal disorders OESOPHAGOBRONCHIAL FISTULA	1.9% 1/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Vascular disorders DEEP VEIN THROMBOSIS	1.9% 1/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.

Other adverse events

Other adverse events
Measure	Docetaxel/Oxaliplatin/Bevacizumab n=52 participants at risk Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of * 70 mg/m\^2 docetaxel intravenously on Day 1 for Cycles 1-6, * 100 mg/m\^2 oxaliplatin intravenously on Day 1 for Cycles 1-6, * 15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy.
Blood and lymphatic system disorders NEUTROPENIA	19.2% 10/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Blood and lymphatic system disorders LEUKOPENIA	13.5% 7/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Blood and lymphatic system disorders ANAEMIA	9.6% 5/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Gastrointestinal disorders DIARRHOEA	63.5% 33/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Gastrointestinal disorders NAUSEA	61.5% 32/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Gastrointestinal disorders VOMITING	40.4% 21/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Gastrointestinal disorders CONSTIPATION	25.0% 13/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Gastrointestinal disorders ABDOMINAL PAIN	19.2% 10/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Gastrointestinal disorders STOMATITIS	19.2% 10/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Gastrointestinal disorders ABDOMINAL DISTENSION	7.7% 4/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Gastrointestinal disorders HAEMORRHOIDS	7.7% 4/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Gastrointestinal disorders DYSPEPSIA	5.8% 3/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Gastrointestinal disorders DYSPHAGIA	5.8% 3/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
General disorders FATIGUE	71.2% 37/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
General disorders PYREXIA	23.1% 12/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
General disorders MUCOSAL INFLAMMATION	11.5% 6/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
General disorders CHILLS	7.7% 4/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
General disorders NON-CARDIAC CHEST PAIN	7.7% 4/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
General disorders ASTHENIA	5.8% 3/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Immune system disorders HYPERSENSITIVITY	9.6% 5/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Infections and infestations FUNGAL INFECTION	7.7% 4/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Infections and infestations URINARY TRACT INFECTION	5.8% 3/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Investigations WEIGHT DECREASED	21.2% 11/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Investigations HAEMOGLOBIN DECREASED	9.6% 5/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Investigations WHITE BLOOD CELL COUNT DECREASED	9.6% 5/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Investigations NEUTROPHIL COUNT DECREASED	7.7% 4/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Investigations BLOOD ALKALINE PHOSPHATASE INCREASED	5.8% 3/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Investigations BLOOD TRIGLYCERIDES INCREASED	5.8% 3/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Investigations PLATELET COUNT DECREASED	5.8% 3/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Metabolism and nutrition disorders ANOREXIA	28.8% 15/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Metabolism and nutrition disorders HYPERGLYCAEMIA	17.3% 9/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Metabolism and nutrition disorders HYPOALBUMINAEMIA	15.4% 8/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Metabolism and nutrition disorders DEHYDRATION	13.5% 7/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Metabolism and nutrition disorders HYPERKALAEMIA	9.6% 5/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Metabolism and nutrition disorders HYPOKALAEMIA	9.6% 5/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Metabolism and nutrition disorders HYPONATRAEMIA	7.7% 4/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Metabolism and nutrition disorders DECREASED APPETITE	5.8% 3/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Metabolism and nutrition disorders HYPERTRIGLYCERIDAEMIA	5.8% 3/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Metabolism and nutrition disorders HYPOCALCAEMIA	5.8% 3/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Musculoskeletal and connective tissue disorders ARTHRALGIA	13.5% 7/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Musculoskeletal and connective tissue disorders BACK PAIN	13.5% 7/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	13.5% 7/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Musculoskeletal and connective tissue disorders MYALGIA	7.7% 4/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	5.8% 3/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Nervous system disorders DYSGEUSIA	19.2% 10/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Nervous system disorders NEUROPATHY PERIPHERAL	19.2% 10/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	17.3% 9/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Nervous system disorders HEADACHE	13.5% 7/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Psychiatric disorders INSOMNIA	26.9% 14/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Psychiatric disorders DEPRESSION	11.5% 6/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Psychiatric disorders ANXIETY	9.6% 5/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Renal and urinary disorders PROTEINURIA	13.5% 7/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Respiratory, thoracic and mediastinal disorders COUGH	23.1% 12/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	17.3% 9/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	15.4% 8/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Respiratory, thoracic and mediastinal disorders HICCUPS	9.6% 5/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Respiratory, thoracic and mediastinal disorders RHINITIS ALLERGIC	9.6% 5/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Respiratory, thoracic and mediastinal disorders DYSPHONIA	7.7% 4/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Respiratory, thoracic and mediastinal disorders HAEMOPTYSIS	7.7% 4/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	5.8% 3/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Skin and subcutaneous tissue disorders ALOPECIA	46.2% 24/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Skin and subcutaneous tissue disorders RASH	9.6% 5/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Skin and subcutaneous tissue disorders NAIL DISORDER	7.7% 4/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Skin and subcutaneous tissue disorders NAIL DISCOLOURATION	5.8% 3/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.
Vascular disorders HYPERTENSION	19.2% 10/52 In the table below for 'other adverse events', the number of participants affected are participants who exhibited one or more of any adverse event.

Additional Information

Trial Transparency Team

Sanofi-Aventis

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigator shall have the right to independently publish study results from his site after a multicenter publication, or 12 months after the completion of the study by all sites. He must provide the sponsor a copy of any such publication derived from the study for review and comment at least 60 days in advance of any submission for publication. The Sponsor may request for the publication to be delayed for a limited time, not to exceed 90 days to preserve its proprietary rights.
Publication restrictions are in place

Restriction type: OTHER