Trial Outcomes & Findings for Budesonide in Treating Patients With Lung Nodules at High Risk of Developing Lung Cancer (NCT NCT00321893)
NCT ID: NCT00321893
Last Updated: 2016-01-25
Results Overview
Lung nodules (nodule characteristics) in a person-specific analysis by Response Evaluation Criteria In Solid Tumors (RECIST) criteria using Computed Tomography (CT) detection: Persistent lung nodules detected at CT scan from previous year with 1 of following: longest diameter between 4\&5 mm. Nodules may be stable or grown from the previous year (\< 5 mm does not require additional diagnostic follow-up); longest diameter between 5.1\& 8mm. Nodules may be stable or grown from the previous year. If grown, doubling time should be \>1 year; longest diameter \> 8 mm with negative positron positron emission tomography (PET) scan, negative CT enhancement. Nodule should have grown with doubling time between 1\& 5 years; -longest diameter \>8mm, non solid or partially solid nodules, stable or grown with doubling time between 1\&5 years. Participants followed from baseline to 3 Years, follow up CT assessment planned at 12 months.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
225 participants
Primary outcome timeframe
Baseline assessment
Results posted on
2016-01-25
Participant Flow
Recruitment Period: April 2006 to July 2007. Participants were recruited in Milan, Italy at the European Institute of Oncology.
Of 225 participants registered, 23 participants were excluded from the trial before assignment to groups.
Participant milestones
| Measure |
Arm I: Budesonide
Inhaled Budesonide 800 micrograms (ug) twice daily for 1 year
|
Arm II: Placebo
Inhaled placebo twice daily for 1 year
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
101
|
|
Overall Study
COMPLETED
|
77
|
87
|
|
Overall Study
NOT COMPLETED
|
24
|
14
|
Reasons for withdrawal
| Measure |
Arm I: Budesonide
Inhaled Budesonide 800 micrograms (ug) twice daily for 1 year
|
Arm II: Placebo
Inhaled placebo twice daily for 1 year
|
|---|---|---|
|
Overall Study
Non-Compliance/Refusal
|
16
|
10
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Adverse Event
|
6
|
3
|
Baseline Characteristics
Budesonide in Treating Patients With Lung Nodules at High Risk of Developing Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm I: Budesonide
n=101 Participants
Inhaled Budesonide 800 ug twice daily for 1 year
|
Arm II: Placebo
n=101 Participants
Inhaled placebo twice daily for 1 year
|
Total
n=202 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
96 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Continuous
|
59 years
n=5 Participants
|
59 years
n=7 Participants
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
101 participants
n=5 Participants
|
101 participants
n=7 Participants
|
202 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline assessmentPopulation: Per person analysis in overall randomized study (202 participants) using identification (baseline) CT.
Lung nodules (nodule characteristics) in a person-specific analysis by Response Evaluation Criteria In Solid Tumors (RECIST) criteria using Computed Tomography (CT) detection: Persistent lung nodules detected at CT scan from previous year with 1 of following: longest diameter between 4\&5 mm. Nodules may be stable or grown from the previous year (\< 5 mm does not require additional diagnostic follow-up); longest diameter between 5.1\& 8mm. Nodules may be stable or grown from the previous year. If grown, doubling time should be \>1 year; longest diameter \> 8 mm with negative positron positron emission tomography (PET) scan, negative CT enhancement. Nodule should have grown with doubling time between 1\& 5 years; -longest diameter \>8mm, non solid or partially solid nodules, stable or grown with doubling time between 1\&5 years. Participants followed from baseline to 3 Years, follow up CT assessment planned at 12 months.
Outcome measures
| Measure |
Arm I: Budesonide
n=137 Lesions
Inhaled Budesonide 800 ug twice daily for 1 year
|
Arm II: Placebo
n=142 Lesions
Inhaled placebo twice daily for 1 year
|
|---|---|---|
|
Number CT- Detected Lung Nodules by Participant
Nonsolid
|
12 lung nodules
|
14 lung nodules
|
|
Number CT- Detected Lung Nodules by Participant
Partially Solid
|
26 lung nodules
|
19 lung nodules
|
|
Number CT- Detected Lung Nodules by Participant
Solid
|
99 lung nodules
|
109 lung nodules
|
PRIMARY outcome
Timeframe: Baseline assessmentPopulation: Per person analysis. Per person analysis in overall randomized study (202 participants) using identification (baseline) CT.
Lung nodules (nodule characteristics) in a person-specific analysis by Response Evaluation Criteria In Solid Tumors (RECIST) criteria using Computed Tomography (CT) detection. Nodule type categorized as: Nonsolid, Partially Solid, or Solid. Persistent lung nodules detected at CT scan from previous year with 1 of following: longest diameter between 4\&5 mm. Nodules may be stable or grown from the previous year (\< 5 mm does not require additional diagnostic follow-up); longest diameter between 5.1\& 8mm. Nodules may be stable or grown from the previous year. If grown, doubling time should be \>1 year; longest diameter \> 8 mm with negative positron positron emission tomography (PET) scan, negative CT enhancement. Nodule should have grown with doubling time between 1\& 5 years; -longest diameter \>8mm, non solid or partially solid nodules, stable or grown with doubling time between 1\&5 years
Outcome measures
| Measure |
Arm I: Budesonide
n=137 nodules
Inhaled Budesonide 800 ug twice daily for 1 year
|
Arm II: Placebo
n=142 nodules
Inhaled placebo twice daily for 1 year
|
|---|---|---|
|
Size of CT- Detected Lung Nodules by Participant
4-5 mm
|
94 lung nodules
|
100 lung nodules
|
|
Size of CT- Detected Lung Nodules by Participant
5-8 mm
|
40 lung nodules
|
42 lung nodules
|
|
Size of CT- Detected Lung Nodules by Participant
>8 mm
|
3 lung nodules
|
0 lung nodules
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: Per person analysis. Excluded from analysis were three participants in Arm I: Budesonide and one participant in Arm II: Placebo who refused the Computed Tomography (CT) scan.
For single nodules \>5 mm, clinical meaningful shrinkage of 30% or \> longest diameter (LD) considered treatment success after 1 year treatment; for \<5 mm, complete disappearance considered treatment success. Multiple lesions success is complete response (CR) or partial response (PR) according to RECIST while failure when progression disease (PD) or stable disease (SD). CR: disappearance all target \& non target lesions + no appearance new lesions; PR: CR for target lesions+incomplete/SD for non target lesions+no new lesions or PR (i.e., 30%\<sum LD target lesions) for target lesions + no PD for non target lesions + no appearance of new lesions; PD: PD (at least 20% \> sum LD of target lesions) for target lesions irrespective of response of non target lesions or PD for non target lesions irrespective of response for target lesions/or appearance new lesions irrespective of response of target/or non target lesions; SD: neither sufficient shrinkage for PR nor increase for PD.
Outcome measures
| Measure |
Arm I: Budesonide
n=98 Participants
Inhaled Budesonide 800 ug twice daily for 1 year
|
Arm II: Placebo
n=100 Participants
Inhaled placebo twice daily for 1 year
|
|---|---|---|
|
Number of Participant Overall Responses as Measured by RECIST Criteria at 12 Months
CR/PR
|
2 participants
|
1 participants
|
|
Number of Participant Overall Responses as Measured by RECIST Criteria at 12 Months
SD
|
88 participants
|
89 participants
|
|
Number of Participant Overall Responses as Measured by RECIST Criteria at 12 Months
PD
|
8 participants
|
10 participants
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: Per person analysis. Excluded from analysis were three participants in Arm I: Budesonide and one participant in Arm II: Placebo who refused the follow up Computed Tomography (CT) scan.
Number of participants with response according to RECIST criteria. For single nodules \> 5 mm, clinical meaningful shrinkage of 30% or \> of longest diameter (LD) considered treatment success after 1 year of treatment. For single nodules with LD \<5 mm, complete disappearance considered treatment success. In case of multiple lesions success of treatment is when complete response (CR) or partial response (PR) occurs according to RECIST criteria.
Outcome measures
| Measure |
Arm I: Budesonide
n=98 Participants
Inhaled Budesonide 800 ug twice daily for 1 year
|
Arm II: Placebo
n=100 Participants
Inhaled placebo twice daily for 1 year
|
|---|---|---|
|
Participant Overall Response (by Tumor Type Subsolid or Solid Tumor) as Measured by RECIST Criteria at 12 Months
Subsolid, CR/PR
|
2 participants
|
1 participants
|
|
Participant Overall Response (by Tumor Type Subsolid or Solid Tumor) as Measured by RECIST Criteria at 12 Months
Subsolid, SD
|
28 participants
|
26 participants
|
|
Participant Overall Response (by Tumor Type Subsolid or Solid Tumor) as Measured by RECIST Criteria at 12 Months
Subsolid, PD
|
3 participants
|
3 participants
|
|
Participant Overall Response (by Tumor Type Subsolid or Solid Tumor) as Measured by RECIST Criteria at 12 Months
Solid, CR/PR
|
0 participants
|
0 participants
|
|
Participant Overall Response (by Tumor Type Subsolid or Solid Tumor) as Measured by RECIST Criteria at 12 Months
Solid, SD
|
60 participants
|
63 participants
|
|
Participant Overall Response (by Tumor Type Subsolid or Solid Tumor) as Measured by RECIST Criteria at 12 Months
Solid, PD
|
5 participants
|
7 participants
|
Adverse Events
Arm I: Budesonide
Serious events: 5 serious events
Other events: 98 other events
Deaths: 0 deaths
Arm II: Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I: Budesonide
n=98 participants at risk
Inhaled Budesonide 800 ug twice daily for 1 year
|
Arm II: Placebo
n=101 participants at risk
Inhaled placebo twice daily for 1 year
|
|---|---|---|
|
Psychiatric disorders
Bipolar Affective Disorder
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Renal and urinary disorders
Left Ureter Non-Invasive Carcinoma
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Renal and urinary disorders
Prostate Cancer
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Vascular disorders
Surgery forArtery Stenosis Lower Limb
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Nervous system disorders
TIA
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
Other adverse events
| Measure |
Arm I: Budesonide
n=98 participants at risk
Inhaled Budesonide 800 ug twice daily for 1 year
|
Arm II: Placebo
n=101 participants at risk
Inhaled placebo twice daily for 1 year
|
|---|---|---|
|
Immune system disorders
Allergic Reaction
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Ankle Trauma
|
2.0%
2/98 • Number of events 2 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic Attack
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.1%
3/98 • Number of events 3 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Renal and urinary disorders
BPH
|
2.0%
2/98 • Number of events 2 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Infections and infestations
Bronchitis
|
8.2%
8/98 • Number of events 8 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Infections and infestations
Candida
|
6.1%
6/98 • Number of events 7 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
2.0%
2/98 • Number of events 2 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Cervical Arthrosis
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Cold
|
3.1%
3/98 • Number of events 4 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Gastrointestinal disorders
Colitis
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Adenoma Polyp
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Eye disorders
Conjunctival Hyperhemia
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Eye disorders
Conjunctivitis
|
1.0%
1/98 • Number of events 2 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Gastrointestinal disorders
Constipation
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
14/98 • Number of events 16 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.99%
1/101 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Cramps
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/98 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.99%
1/101 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Infections and infestations
Dental Abscess
|
7.1%
7/98 • Number of events 7 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Gastrointestinal disorders
Dental Implant
|
1.0%
1/98 • Number of events 2 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Surgical and medical procedures
Dental Surgery
|
2.0%
2/98 • Number of events 2 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Psychiatric disorders
Depression
|
2.0%
2/98 • Number of events 2 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Nervous system disorders
Diabetic Neuropathy
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Gastrointestinal disorders
Diarrhea
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Gastrointestinal disorders
Dry Mouth
|
5.1%
5/98 • Number of events 5 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Gastrointestinal disorders
Dyspepsia
|
2.0%
2/98 • Number of events 2 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.1%
6/98 • Number of events 7 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.99%
1/101 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Gastrointestinal disorders
Enteritis
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.0%
2/98 • Number of events 2 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Gastrointestinal disorders
Esophagitis
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Cardiac disorders
Extrasystoles
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
General disorders
Fatigue
|
4.1%
4/98 • Number of events 4 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
General disorders
Fever
|
3.1%
3/98 • Number of events 3 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
General disorders
Flu
|
7.1%
7/98 • Number of events 12 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Gastrointestinal disorders
Gastric Pain
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Gastrointestinal disorders
Gastric Pyrosis
|
3.1%
3/98 • Number of events 3 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Gastrointestinal disorders
Gastritis
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Gastrointestinal disorders
Gastroesophageal Reflux
|
2.0%
2/98 • Number of events 2 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Infections and infestations
Gingivitis
|
2.0%
2/98 • Number of events 2 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Gastrointestinal disorders
Glossitis
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Gout
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Hair Loss
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Nervous system disorders
Hands Paresthesia
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Nervous system disorders
Headache
|
4.1%
4/98 • Number of events 4 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Gastrointestinal disorders
Hemorroids
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Investigations
High ALT
|
4.1%
4/98 • Number of events 4 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Investigations
High AST
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Investigations
High Bilirubin
|
2.0%
2/98 • Number of events 2 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Investigations
High BUN
|
3.1%
3/98 • Number of events 3 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Metabolism and nutrition disorders
High Chloride
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Investigations
High Cholesterol
|
2.0%
2/98 • Number of events 2 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Investigations
High Creatinine
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Investigations
High Leukocites
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Metabolism and nutrition disorders
High Plasma Homocysteine
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Metabolism and nutrition disorders
High Potassium
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
12.2%
12/98 • Number of events 13 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Endocrine disorders
Hot Flashes
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.0%
1/98 • Number of events 2 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Vascular disorders
Hypertension
|
6.1%
6/98 • Number of events 6 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Gastrointestinal disorders
Inappetence
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Inflammatory Lung Lesion
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Insect Bite
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Psychiatric disorders
Insomnia
|
2.0%
2/98 • Number of events 2 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Intercostal Pain
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Knee Distorsion
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Knee Pain
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Knee Trauma
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Nervous system disorders
Lipothymia
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Nervous system disorders
Loss of Memory
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Endocrine disorders
Low Cortisol
|
15.3%
15/98 • Number of events 15 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Investigations
Low Hematocrit
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.99%
1/101 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Investigations
Low Hemoglobin
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Investigations
Low Platelets
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Low Voice
|
22.4%
22/98 • Number of events 24 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.99%
1/101 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung Flogistic Lesion
|
0.00%
0/98 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.99%
1/101 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Migratory Erythema
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Gastrointestinal disorders
Mucositis
|
4.1%
4/98 • Number of events 4 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Contracture
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Pain
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Gastrointestinal disorders
Nausea
|
4.1%
4/98 • Number of events 4 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Infections and infestations
Pap Test Positivity
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.99%
1/101 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Gastrointestinal disorders
Papilloma
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Gastrointestinal disorders
Periodonitis
|
1.0%
1/98 • Number of events 3 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Perleche
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Infections and infestations
Pharyngitis
|
3.1%
3/98 • Number of events 3 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngodynia
|
3.1%
3/98 • Number of events 3 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Vascular disorders
Phlebitis
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Renal and urinary disorders
Prostatitis
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Renal and urinary disorders
Renal Colic
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
General disorders
Retrosternal Weight
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.99%
1/101 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Immune system disorders
Rhinitis
|
2.0%
2/98 • Number of events 2 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Gastrointestinal disorders
Scialorrhea
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Nervous system disorders
Sciatic Neuralgia
|
2.0%
2/98 • Number of events 2 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Shoulder Dislocation
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
1.0%
1/98 • Number of events 2 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
4.1%
4/98 • Number of events 4 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Gastrointestinal disorders
Stipsis
|
2.0%
2/98 • Number of events 2 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Gastrointestinal disorders
Stomatitis
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Cardiac disorders
Superventricular Tachycardia
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Surgical and medical procedures
Surgery for a Periumbelical Lipoma
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Surgical and medical procedures
Surgery for Suspect Oral Leukoplakia
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Gastrointestinal disorders
Suspect Oral Luekoplakia
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Gastrointestinal disorders
Swallowing Difficulties
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Sweating
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Cardiac disorders
Tachycardia
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Gastrointestinal disorders
Taste Alteration
|
8.2%
8/98 • Number of events 8 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Gastrointestinal disorders
Teeth Pain
|
2.0%
2/98 • Number of events 2 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Gastrointestinal disorders
Teeth Sensitivity
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Renal and urinary disorders
Testis Cyst
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.99%
1/101 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Infections and infestations
Tonsillitis
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Infections and infestations
Tracheitis
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Renal and urinary disorders
Urine Frequency
|
2.0%
2/98 • Number of events 2 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Renal and urinary disorders
Urinary Retention
|
2.0%
2/98 • Number of events 2 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Infections and infestations
Urinary Tract Infection
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Renal and urinary disorders
Uterine Polyp
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Vascular disorders
Vessel Injury-Artery: Lower Extremity
|
2.0%
2/98 • Number of events 2 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Eye disorders
Visus Reduction
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
2/98 • Number of events 3 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Investigations
Weight Loss
|
2.0%
2/98 • Number of events 2 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
|
Infections and infestations
Wound Infection
|
1.0%
1/98 • Number of events 1 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
0.00%
0/101 • Adverse event collection at each visit from 3 month evaluation to month after follow up CT scan at 12 months, and with each visit. Overall active study period April 2006 to August 2008, 2 years and 4 months
|
Additional Information
Powel H. Brown, MD, PhD/Professor of Medicine and Cancer Prevention
University of Texas MD Anderson
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60