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Trial record 22 of 195 for:    Oral Cancer | ( Map: Mexico )

Trial of Vinflunine Plus Capecitabine in Advanced Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01095003
Recruitment Status : Completed
First Posted : March 29, 2010
Results First Posted : September 13, 2019
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: Vinflunine plus Capecitabine
Drug: Capecitabine
Enrollment 770
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vinflunine Plus Capecitabine Capecitabine Single-agent
Hide Arm/Group Description

Vinflunine plus Capecitabine: Vinflunine 280mg/m² as a 20-minute i.v. infusion on day 1 of each cycle repeated every 3 weeks

Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks

Capecitabine: Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks
Period Title: Overall Study
Started 384 386
Completed 0 0
Not Completed 384 386
Arm/Group Title Capecitabine Single-agent Vinflunine Plus Capecitabine Total
Hide Arm/Group Description Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks

Vinflunine plus Capecitabine: Vinflunine 280mg/m² as a 20-minute i.v. infusion on day 1 of each cycle repeated every 3 weeks

Capecitabine: Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks

Total of all reporting groups
Overall Number of Baseline Participants 386 384 770
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 386 participants 384 participants 770 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
340
  88.1%
329
  85.7%
669
  86.9%
>=65 years
46
  11.9%
55
  14.3%
101
  13.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 386 participants 384 participants 770 participants
Female
386
 100.0%
384
 100.0%
770
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Progression Free Survival
Hide Description

PFS is defined as time from date of randomization to date of the first documentation of objective tumor progression (according to the Independent Response Review Committee (IRC) and based on RECIST version 1.1) or death due to any cause.

The PFS was primarily analysed in the Intent-to-treat (ITT) population. Patients lost to follow-up, or without a known record of progression or death at time of analysis had the progression-free survival censored at the date of last tumour assessment or the date of last contact of a follow-up showing no progression, whichever occurs last.

Time Frame Baseline up to 2 years 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Vinflunine Plus Capecitabine Capecitabine Single-agent
Hide Arm/Group Description:

Vinflunine plus Capecitabine: Vinflunine 280mg/m² as a 20-minute i.v. infusion on day 1 of each cycle repeated every 3 weeks

Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks

Capecitabine: Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks
Overall Number of Participants Analyzed 384 386
Median (95% Confidence Interval)
Unit of Measure: Months
5.6
(5.3 to 6.3)
4.3
(4.1 to 5.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vinflunine Plus Capecitabine, Capecitabine Single-agent
Comments The final analysis of progression free survival was conducted once the required number of events(615 progressions or deaths) was reached.using the IRC assessment of date of progressions following the blinded radiological and clinical review of data. Kaplan-Meier curves and life tables by treatment arm were provided.A stratified Cox proportional model was used to compare the two treatment arms
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0426
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.71 to 0.99
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival
Hide Description The overall survival (OS) was defined as the duration between the date of randomisation and the date of death from any cause. The OS analysis was performed in the ITT population and the eligible and per protocol populations once the required number of events (631 deaths) was observed Patients lost to follow-up, or without a known record of death at time of analysis had the OS censored at the date of last contact.
Time Frame Baseline upto 3 years 10 months
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Hide Analysis Population Description
ITT population
Arm/Group Title Vinflunine Plus Capecitabine Capecitabine Single-agent
Hide Arm/Group Description:

Vinflunine plus Capecitabine: Vinflunine 280mg/m² as a 20-minute i.v. infusion on day 1 of each cycle repeated every 3 weeks

Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks

Capecitabine: Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks
Overall Number of Participants Analyzed 384 386
Median (95% Confidence Interval)
Unit of Measure: Months
13.9
(11.9 to 15)
11.7
(10.8 to 13.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vinflunine Plus Capecitabine, Capecitabine Single-agent
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7657
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.83 to 1.15
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Overall Response Rate (ORR)
Hide Description ORR defined as documentation of complete or partial response that was subsequently confirmed to first documentation of disease progression or to death due to any cause, whichever occurred first.
Time Frame Baseline upto 2 years 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Vinflunine Plus Capecitabine Capecitabine Single-agent
Hide Arm/Group Description:

Vinflunine plus Capecitabine: Vinflunine 280mg/m² as a 20-minute i.v. infusion on day 1 of each cycle repeated every 3 weeks

Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks

Capecitabine: Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks
Overall Number of Participants Analyzed 384 386
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent
22.9
(18.8 to 27.5)
17.9
(14.2 to 22.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vinflunine Plus Capecitabine, Capecitabine Single-agent
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.103
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
4.Secondary Outcome
Title Disease Control Rate
Hide Description Disease control rate defined (DCR) as the sum of confirmed complete response, confirmed partial response and stabilisation rate.
Time Frame Baseline up to 2 years 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Vinflunine Plus Capecitabine Capecitabine Single-agent
Hide Arm/Group Description:

Vinflunine plus Capecitabine: Vinflunine 280mg/m² as a 20-minute i.v. infusion on day 1 of each cycle repeated every 3 weeks

Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks

Capecitabine: Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks
Overall Number of Participants Analyzed 384 386
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent
57.3
(52.2 to 62.3)
47.9
(42.9 to 53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vinflunine Plus Capecitabine, Capecitabine Single-agent
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0089
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
5.Secondary Outcome
Title Duration of Response
Hide Description Measured from the first time that measurement criteria were first met for objective response (documented CR or PR) until recurrence/progression or death whatever the cause.
Time Frame Baseline up to 2 years 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Vinflunine Plus Capecitabine Capecitabine Single-agent
Hide Arm/Group Description:

Patients received (in combination with capecitabine)

• Vinflunine at the dose of 280 mg/m² and as a 20-minute IV. infusion on day 1 of each cycle repeated every 3 weeks.

Vinflunine plus Capecitabine: Vinflunine 280mg/m² as a 20-minute i.v. infusion on day 1 of each cycle repeated every 3 weeks

Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks

Capecitabine at the dose of 825mg/m² per os twice per day each morning and each evening for 14 consecutive days beginning on day 1 of each cycle repeated every 3 weeks (self-administered).

Capecitabine: Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks

Overall Number of Participants Analyzed 384 386
Median (Full Range)
Unit of Measure: Months
57.3
(52.2 to 62.3)
47.9
(42.9 to 53)
Time Frame Adverse events (AEs) are reported from time of first dose of study treatment up to the end of study period (treatment period + follow-up period) up to 5 years 9 months.
Adverse Event Reporting Description AEs were collected from treated patients who received at least one dose of study treatment (383 patients in each arm). The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another. Specific AE tables were generated separately as per European format.
 
Arm/Group Title Vinflunine Plus Capecitabine Capecitabine Single-agent
Hide Arm/Group Description

Vinflunine plus Capecitabine: Vinflunine 280mg/m² as a 20-minute i.v. infusion on day 1 of each cycle repeated every 3 weeks

Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks

Capecitabine: Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks
All-Cause Mortality
Vinflunine Plus Capecitabine Capecitabine Single-agent
Affected / at Risk (%) Affected / at Risk (%)
Total   345/384 (89.84%)   348/386 (90.16%) 
Show Serious Adverse Events Hide Serious Adverse Events
Vinflunine Plus Capecitabine Capecitabine Single-agent
Affected / at Risk (%) Affected / at Risk (%)
Total   107/383 (27.94%)   85/383 (22.19%) 
Blood and lymphatic system disorders     
Anaemia  1  4/383 (1.04%)  3/383 (0.78%) 
Febrile neutropenia  1  7/383 (1.83%)  2/383 (0.52%) 
Haemoytique anaemia  1  0/383 (0.00%)  0/383 (0.00%) 
Leukopenia  1  1/383 (0.26%)  0/383 (0.00%) 
Neutropenia  1  6/383 (1.57%)  1/383 (0.26%) 
Thrombocytopenia  1  2/383 (0.52%)  1/383 (0.26%) 
Cardiac disorders     
Anginal pectoris  1  1/383 (0.26%)  0/383 (0.00%) 
Cardiomyopathy  1  0/383 (0.00%)  1/383 (0.26%) 
Ear and labyrinth disorders     
Ear pain  1  0/383 (0.00%)  1/383 (0.26%) 
Gastrointestinal disorders     
Abdominal distension  1  1/383 (0.26%)  0/383 (0.00%) 
Abdominal pain  1  6/383 (1.57%)  3/383 (0.78%) 
Abdominal pain upper  1  4/383 (1.04%)  0/383 (0.00%) 
Colitis  1  0/383 (0.00%)  1/383 (0.26%) 
Constipation  1  9/383 (2.35%)  0/383 (0.00%) 
Diarrhoea  1  4/383 (1.04%)  6/383 (1.57%) 
Gastritis  1  1/383 (0.26%)  0/383 (0.00%) 
Ileus paralytic  1  1/383 (0.26%)  0/383 (0.00%) 
Intestinal obstruction  1  6/383 (1.57%)  1/383 (0.26%) 
Nausea  1  3/383 (0.78%)  1/383 (0.26%) 
Reflux gastric  1  0/383 (0.00%)  1/383 (0.26%) 
Stomatitis  1  4/383 (1.04%)  1/383 (0.26%) 
Subileus  1  1/383 (0.26%)  0/383 (0.00%) 
Vomiting  1  6/383 (1.57%)  0/383 (0.00%) 
General disorders     
Asthenia  1  1/383 (0.26%)  0/383 (0.00%) 
Chest pain  1  3/383 (0.78%)  0/383 (0.00%) 
Condition aggravated  1  2/383 (0.52%)  6/383 (1.57%) 
Death  1  0/383 (0.00%)  2/383 (0.52%) 
Fatigue  1  2/383 (0.52%)  1/383 (0.26%) 
Injection site extravasation  1  1/383 (0.26%)  0/383 (0.00%) 
Mucosal inflammation  1  1/383 (0.26%)  0/383 (0.00%) 
Multi organ failure  1  0/383 (0.00%)  1/383 (0.26%) 
Pain  1  1/383 (0.26%)  0/383 (0.00%) 
Pyrexia  1  1/383 (0.26%)  1/383 (0.26%) 
Sudden death  1  1/383 (0.26%)  2/383 (0.52%) 
Hepatobiliary disorders     
Cholecytitis  1  1/383 (0.26%)  0/383 (0.00%) 
Cholecystetis acute  1  0/383 (0.00%)  1/383 (0.26%) 
Hepatic pain  1  1/383 (0.26%)  0/383 (0.00%) 
Hyperbilirubinemai  1  1/383 (0.26%)  3/383 (0.78%) 
Immune system disorders     
Hypersensitivity  1  0/383 (0.00%)  1/383 (0.26%) 
Infections and infestations     
Cellulitis  1  1/383 (0.26%)  0/383 (0.00%) 
Gastroenteritis  1  0/383 (0.00%)  1/383 (0.26%) 
Herpes Zoster  1  1/383 (0.26%)  0/383 (0.00%) 
Localised infection  1  1/383 (0.26%)  0/383 (0.00%) 
Lower respiaratory tract infection  1  1/383 (0.26%)  0/383 (0.00%) 
Neutropenic infection  1  1/383 (0.26%)  0/383 (0.00%) 
Neutropenic sepsis  1  1/383 (0.26%)  0/383 (0.00%) 
Pneumonia  1  3/383 (0.78%)  2/383 (0.52%) 
Pneumonia streptococcal  1  1/383 (0.26%)  0/383 (0.00%) 
Respiratory tract infection  1  0/383 (0.00%)  1/383 (0.26%) 
Sepsis  1  1/383 (0.26%)  0/383 (0.00%) 
Urinary tract infection  1  1/383 (0.26%)  0/383 (0.00%) 
Injury, poisoning and procedural complications     
Device occlusion  1  1/383 (0.26%)  0/383 (0.00%) 
Femur fracture  1  1/383 (0.26%)  1/383 (0.26%) 
Medication error  1  1/383 (0.26%)  0/383 (0.00%) 
Pneumothorax traumatic  1  1/383 (0.26%)  0/383 (0.00%) 
Wrist fracture  1  1/383 (0.26%)  0/383 (0.00%) 
Investigations     
ALAT increased  1  0/383 (0.00%)  1/383 (0.26%) 
ASTT increased  1  0/383 (0.00%)  1/383 (0.26%) 
Biopsy  1  1/383 (0.26%)  0/383 (0.00%) 
Metabolism and nutrition disorders     
Anorexia  1  1/383 (0.26%)  1/383 (0.26%) 
Dehydration  1  2/383 (0.52%)  1/383 (0.26%) 
Diabetes mellitus inadequate control  1  0/383 (0.00%)  1/383 (0.26%) 
Hyperglycaemia  1  1/383 (0.26%)  0/383 (0.00%) 
Hypoalbuminaemia  1  0/383 (0.00%)  1/383 (0.26%) 
Hypokaelemia  1  1/383 (0.26%)  0/383 (0.00%) 
Hyponatraemia  1  2/383 (0.52%)  0/383 (0.00%) 
Musculoskeletal and connective tissue disorders     
Bone pain  1  0/383 (0.00%)  2/383 (0.52%) 
Musculoskeletal chest pain  1  0/383 (0.00%)  1/383 (0.26%) 
Myalgia  1  1/383 (0.26%)  0/383 (0.00%) 
Pain in extremity  1  1/383 (0.26%)  0/383 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer pain  1  1/383 (0.26%)  0/383 (0.00%) 
Colon cancer  1  0/383 (0.00%)  1/383 (0.26%) 
Malignant neoplasmprogression  1  34/383 (8.88%)  32/383 (8.36%) 
Malignant pleural effusion  1  2/383 (0.52%)  0/383 (0.00%) 
Paraneoplastic syndrome  1  1/383 (0.26%)  0/383 (0.00%) 
Nervous system disorders     
Brachial plexopathy  1  1/383 (0.26%)  0/383 (0.00%) 
Cerebrovascular accident  1  2/383 (0.52%)  2/383 (0.52%) 
Coma  1  0/383 (0.00%)  1/383 (0.26%) 
Headache  1  1/383 (0.26%)  1/383 (0.26%) 
Hydrocephalus  1  0/383 (0.00%)  1/383 (0.26%) 
Intracranial pressure increased  1  1/383 (0.26%)  0/383 (0.00%) 
Subarachnoid haemorrrhage  1  0/383 (0.00%)  1/383 (0.26%) 
Vascular encephalopathy  1  0/383 (0.00%)  1/383 (0.26%) 
Psychiatric disorders     
Anxiety  1  1/383 (0.26%)  0/383 (0.00%) 
Reproductive system and breast disorders     
Dysfunctional uterine bleeding  1  0/383 (0.00%)  1/383 (0.26%) 
Respiratory, thoracic and mediastinal disorders     
Bronchospasm  1  0/383 (0.00%)  1/383 (0.26%) 
Dyspnoea  1  1/383 (0.26%)  5/383 (1.31%) 
Hydrothorax  1  0/383 (0.00%)  1/383 (0.26%) 
Pleuritic pain  1  1/383 (0.26%)  0/383 (0.00%) 
Pneumothorax  1  1/383 (0.26%)  0/383 (0.00%) 
Pulmonary Embolism  1  2/383 (0.52%)  3/383 (0.78%) 
PPES  1  0/383 (0.00%)  1/383 (0.26%) 
Surgical and medical procedures     
Anal fistula excision  1  0/383 (0.00%)  1/383 (0.26%) 
Bile duct stent insertion  1  0/383 (0.00%)  1/383 (0.26%) 
Central venous catherisation  1  2/383 (0.52%)  0/383 (0.00%) 
Haemorrhoid operation  1  0/383 (0.00%)  1/383 (0.26%) 
Surgery  1  1/383 (0.26%)  0/383 (0.00%) 
Vascular disorders     
Deep vein thrombosis  1  2/383 (0.52%)  1/383 (0.26%) 
Hypertensive crisis  1  1/383 (0.26%)  1/383 (0.26%) 
Lymphoedema  1  1/383 (0.26%)  0/383 (0.00%) 
Thrombophlebitis  1  1/383 (0.26%)  0/383 (0.00%) 
1
Term from vocabulary, MedDRA (12.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vinflunine Plus Capecitabine Capecitabine Single-agent
Affected / at Risk (%) Affected / at Risk (%)
Total   257/383 (67.10%)   262/383 (68.41%) 
Blood and lymphatic system disorders     
Neutropenia  1  73/383 (19.06%)  32/383 (8.36%) 
Cardiac disorders     
Cardiac disorders  1  28/383 (7.31%)  22/383 (5.74%) 
Eye disorders     
Eye disorders  1  23/383 (6.01%)  31/383 (8.09%) 
Gastrointestinal disorders     
Abdominal pain  1  119/383 (31.07%)  78/383 (20.37%) 
Abdominal pain upper  1  49/383 (12.79%)  21/383 (5.48%) 
Constipation  1  108/383 (28.20%)  30/383 (7.83%) 
Diarrhoea  1  86/383 (22.45%)  116/383 (30.29%) 
Nausea  1  123/383 (32.11%)  97/383 (25.33%) 
Stomatitis  1  88/383 (22.98%)  41/383 (10.70%) 
Vomiting  1  106/383 (27.68%)  62/383 (16.19%) 
General disorders     
Asthenia  1  66/383 (17.23%)  39/383 (10.18%) 
Fatigue  1  111/383 (28.98%)  92/383 (24.02%) 
Injection site reaction  1  63/383 (16.45%)  0/383 (0.00%) 
Oedema peripheral  1  21/383 (5.48%)  22/383 (5.74%) 
Pyrexia  1  46/383 (12.01%)  35/383 (9.14%) 
Hepatobiliary disorders     
Hepatobiliary disorders  1  29/383 (7.57%)  20/383 (5.22%) 
Infections and infestations     
Infections and infestations  1  95/383 (24.80%)  90/383 (23.50%) 
Investigations     
Weight decreased  1  113/383 (29.50%)  74/383 (19.32%) 
Weight increased  1  55/383 (14.36%)  48/383 (12.53%) 
Metabolism and nutrition disorders     
Anorexia  1  63/383 (16.45%)  37/383 (9.66%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  48/383 (12.53%)  14/383 (3.66%) 
Back pain  1  21/383 (5.48%)  25/383 (6.53%) 
Bone pain  1  39/383 (10.18%)  30/383 (7.83%) 
Musculoskeletal pain  1  20/383 (5.22%)  11/383 (2.87%) 
Myalgia  1  36/383 (9.40%)  5/383 (1.31%) 
Pain in extremity  1  37/383 (9.66%)  23/383 (6.01%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant neoplasm progression  1  34/383 (8.88%)  33/383 (8.62%) 
Nervous system disorders     
Dizziness  1  33/383 (8.62%)  23/383 (6.01%) 
Headache  1  59/383 (15.40%)  38/383 (9.92%) 
Peripheral sensory neuropathy  1  33/383 (8.62%)  19/383 (4.96%) 
Psychiatric disorders     
Insomnia  1  26/383 (6.79%)  14/383 (3.66%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  40/383 (10.44%)  34/383 (8.88%) 
Dyspnoea  1  52/383 (13.58%)  51/383 (13.32%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  42/383 (10.97%)  3/383 (0.78%) 
PPES  1  90/383 (23.50%)  180/383 (47.00%) 
Vascular disorders     
Vascular disorders  1  61/383 (15.93%)  28/383 (7.31%) 
1
Term from vocabulary, MedDRA (12.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Karim Keddad
Organization: Institut de Recherche Pierre Fabre
Phone: +33.5.34.50.61.69
EMail: Karim.keddad@pierre-fabre.com
Layout table for additonal information
Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT01095003     History of Changes
Other Study ID Numbers: L00070 IN 305 B0
2008-004171-21 ( EudraCT Number )
First Submitted: March 24, 2010
First Posted: March 29, 2010
Results First Submitted: May 27, 2019
Results First Posted: September 13, 2019
Last Update Posted: September 13, 2019