Server with XML interface to get trials
library(data.table)
#how to start where you left off last time
#save.image('nicePointB.RData')
#load('nicePointB.RData')
ctdata<-data.frame(NCT.Number=c('NCT01148511','NCT01810042','NCT00674323','NCT00473642'))
ctdata## NCT.Number
## 1 NCT01148511
## 2 NCT01810042
## 3 NCT00674323
## 4 NCT00473642We will start with a very simple loop
#--loop
i=2 #for testing purposes
for (i in 1:nrow(ctdata)) {
# for (i in 1:100) {
nct=as.character(ctdata$NCT.Number[i])
nct #will not be printed in the loop
url=sprintf('http://ClinicalTrials.gov/show/%s?resultsxml=true',nct)
print(url)
}## [1] "http://ClinicalTrials.gov/show/NCT01148511?resultsxml=true"
## [1] "http://ClinicalTrials.gov/show/NCT01810042?resultsxml=true"
## [1] "http://ClinicalTrials.gov/show/NCT00674323?resultsxml=true"
## [1] "http://ClinicalTrials.gov/show/NCT00473642?resultsxml=true"Going into the XML part
sample studies URLs
(use 2 spaces to truly make a new line in RMarkdown) (not used) first http://ClinicalTrials.gov/show/NCT01148511?resultsxml=true http://ClinicalTrials.gov/show/NCT01148511
library(XML)
#library(xml2) hadley-verse alternative
i=1 #for testing purposes
nct=as.character(ctdata$NCT.Number[i])
url=sprintf('http://ClinicalTrials.gov/show/%s?resultsxml=true',nct)
xml = xmlTreeParse(url,useInternalNode=TRUE)
xml## <?xml version="1.0" encoding="UTF-8"?>
## <clinical_study>
## <!-- This xml conforms to an XML Schema at:
## https://clinicaltrials.gov/ct2/html/images/info/public.xsd
## and an XML DTD at:
## https://clinicaltrials.gov/ct2/html/images/info/public.dtd -->
## <required_header>
## <download_date>ClinicalTrials.gov processed this data on November 09, 2015</download_date>
## <link_text>Link to the current ClinicalTrials.gov record.</link_text>
## <url>https://clinicaltrials.gov/show/NCT01148511</url>
## </required_header>
## <id_info>
## <org_study_id>CRFB002ATR01</org_study_id>
## <nct_id>NCT01148511</nct_id>
## </id_info>
## <brief_title>Comparison of Safety, Effectiveness and Quality of Life Outcomes Between Labeled Versus "Treat and Extend" Regimen in Turkish Patients With Choroidal Neovascularisation Due to Age-related Macular Degeneration (AMD)</brief_title>
## <acronym>SALUTE</acronym>
## <official_title>Comparison of Safety, Effectiveness, and Quality-of-life Outcomes Between Labeled Versus "Treat and Extend" Regimen in Turkish Patients With Choroidal Neovascularisation Due to AMD</official_title>
## <sponsors>
## <lead_sponsor>
## <agency>Novartis Pharmaceuticals</agency>
## <agency_class>Industry</agency_class>
## </lead_sponsor>
## </sponsors>
## <source>Novartis</source>
## <oversight_info>
## <authority>Turkey: Sisli Etfal Training and Research Hospital Clinical Research Ethics Committee</authority>
## <authority>Turkey: Uludag University Clinical Research Ethics Committee</authority>
## <authority>Turkey: Istanbul Bilim University Clinical Research Ethics Committee</authority>
## <authority>Turkey: Istanbul University Istanbul Medical Faculty Clinical Research Ethics Committee</authority>
## <authority>Turkey: Istanbul University CerrahpaÅa Medical Faculty Clinical Research Ethics Committee</authority>
## <authority>Turkey: Ankara University Clinical Research Ethics Committee</authority>
## <authority>Turkey: Ege University Clinical Research Ethics Committee</authority>
## <authority>Turkey: Dokuz Eylul University Clinical Research Ethics Committee</authority>
## <authority>Turkey: Cukurova University Clinical Research Ethics Committee</authority>
## <authority>Turkey: Konya Selcuk University Clinical Research Ethics Committee</authority>
## <authority>Turkey: Gazi University Clinical Research Ethics Committee</authority>
## <authority>Turkey: Osmangazi University Clinical Research Ethics Committee</authority>
## </oversight_info>
## <brief_summary>
## <textblock>
## The purpose of the study was to compare 2 treatment regimens for patients suffering from
## choroidal neovascularisation secondary to age-related macular degeneration (AMD). The first
## treatment regimen was the approved AMD treatment of 1 injection each month for 3 months and
## than re-treatment of patients who have a visual loss of more than 5 letters with monthly
## control (Treat and Observe). The second treatment regimen was 1 injection each month for 3
## months and than extending the control period if the macula is dry during the monthly control
## (Treat and Extend). If the "Treat and Extend" regimen is found effective and safe, the
## number of ranibizumab injections, the number of patient visits, the risk of adverse events
## due to the intravitreal injections, and policlinic occupation number could all be reduced.
## </textblock>
## </brief_summary>
## <overall_status>Completed</overall_status>
## <start_date>February 2010</start_date>
## <completion_date type="Actual">April 2012</completion_date>
## <primary_completion_date type="Actual">April 2012</primary_completion_date>
## <phase>Phase 4</phase>
## <study_type>Interventional</study_type>
## <study_design>Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment</study_design>
## <primary_outcome>
## <measure>Change in Best-Corrected Visual Acuity (logMAR) From Baseline to Month 12</measure>
## <time_frame>Baseline to Month 12</time_frame>
## <safety_issue>No</safety_issue>
## <description>Best corrected visual acuity (BCVA) was assessed in the study eye. BCVA measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there are 5 letters per line, the total score for a line on the logMAR chart represents a change of 0.1 log units. The formula for calculating the logMAR BCVA score is: 0.1 + logMAR value of the best line read - 0.02 x number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.</description>
## </primary_outcome>
## <primary_outcome>
## <measure>Change in Letter Count From Baseline to Month 12</measure>
## <time_frame>Baseline to Month 12</time_frame>
## <safety_issue>No</safety_issue>
## <description>Letter count was assessed in the study eye. Measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. A higher letter count score indicates better vision. A negative change score indicates improvement.</description>
## </primary_outcome>
## <secondary_outcome>
## <measure>Letter Count From Baseline to Month 12</measure>
## <time_frame>Baseline to Month 12</time_frame>
## <safety_issue>No</safety_issue>
## <description>Letter count was assessed in the study eye. Measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. Results are reported in various categories of change in letter count.</description>
## </secondary_outcome>
## <secondary_outcome>
## <measure>Number of Visits</measure>
## <time_frame>Baseline to Month 12</time_frame>
## <safety_issue>No</safety_issue>
## </secondary_outcome>
## <secondary_outcome>
## <measure>Follow-up Duration</measure>
## <time_frame>Baseline to Month 12</time_frame>
## <safety_issue>No</safety_issue>
## <description>Follow-up duration was defined as the number of days from Baseline to study discontinuation.</description>
## </secondary_outcome>
## <secondary_outcome>
## <measure>Change in Central Retinal Thickness From Baseline to Month 12</measure>
## <time_frame>Baseline to Month 12</time_frame>
## <safety_issue>No</safety_issue>
## <description>Retinal thickness was measured using Optical Coherence Tomography (OCT).</description>
## </secondary_outcome>
## <secondary_outcome>
## <measure>Quality of Life</measure>
## <time_frame>Visits 2, 6, 9, 12, and 15 (up to 12 months)</time_frame>
## <safety_issue>No</safety_issue>
## <description>The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure a patient's subjective assessment of vision-related quality of life at Visits 2, 6, 9, 12, and 15. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated poorer function.</description>
## </secondary_outcome>
## <number_of_arms>2</number_of_arms>
## <enrollment type="Actual">99</enrollment>
## <condition>Age-related Macular Degeneration</condition>
## <arm_group>
## <arm_group_label>Treat and Extend</arm_group_label>
## <arm_group_type>Experimental</arm_group_type>
## <description>Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.</description>
## </arm_group>
## <arm_group>
## <arm_group_label>Treat and Observe</arm_group_label>
## <arm_group_type>Active Comparator</arm_group_type>
## <description>Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.</description>
## </arm_group>
## <intervention>
## <intervention_type>Drug</intervention_type>
## <intervention_name>Ranibizumab 0.5 mg</intervention_name>
## <description>Ranibizumab was supplied as a sterile solution in sealed glass vials.</description>
## <arm_group_label>Treat and Extend</arm_group_label>
## <arm_group_label>Treat and Observe</arm_group_label>
## <other_name>Lucentis</other_name>
## </intervention>
## <eligibility>
## <criteria>
## <textblock>
## Inclusion Criteria:
##
## - Male or female patients over the age of 50.
##
## - Patients with primary, secondary, or recurrent subfoveal choroidal neovascularization
## (CNV) to AMD with classic, minimal classic, or occult lesions.
##
## - Patients with CNV area ⥠%50 of the total lesion.
##
## - Total lesion area ⤠12 disc areas for minimal classic/occult lesions and ⤠9 disc
## areas for the classic lesions.
##
## - Best-corrected visual acuity (BCVA) score between 73 and 34 letters in the study eye.
##
## Exclusion Criteria:
##
## - BCVA < 34 letters.
##
## - Patients using anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate,
## corticosteroids, or protein kinase C inhibitors, etc) or inclusion in another trial
## (for any eye).
##
## - Verteporphin, external radiational therapy, subfoveal focal laser photocoagulation,
## vitrectomy, or transpupillary thermotherapy application to the eye before the study.
##
## Other protocol-defined inclusion/exclusion criteria may apply.
## </textblock>
## </criteria>
## <gender>Both</gender>
## <minimum_age>50 Years</minimum_age>
## <maximum_age>N/A</maximum_age>
## <healthy_volunteers>No</healthy_volunteers>
## </eligibility>
## <overall_official>
## <last_name>Novartis Pharmaceuticals</last_name>
## <role>Study Director</role>
## <affiliation>Novartis Pharmaceuticals</affiliation>
## </overall_official>
## <location>
## <facility>
## <name>Novartis Investigative Site</name>
## <address>
## <city>Adana</city>
## <country>Turkey</country>
## </address>
## </facility>
## </location>
## <location>
## <facility>
## <name>Novartis Investigational Site</name>
## <address>
## <city>Ankara</city>
## <country>Turkey</country>
## </address>
## </facility>
## </location>
## <location>
## <facility>
## <name>Novartis Investigative Site</name>
## <address>
## <city>Ankara</city>
## <country>Turkey</country>
## </address>
## </facility>
## </location>
## <location>
## <facility>
## <name>Novartis Investigative Site</name>
## <address>
## <city>Bursa</city>
## <country>Turkey</country>
## </address>
## </facility>
## </location>
## <location>
## <facility>
## <name>Novartis Investigative Site</name>
## <address>
## <city>EskiÅehir</city>
## <country>Turkey</country>
## </address>
## </facility>
## </location>
## <location>
## <facility>
## <name>Novartis Investigative Site</name>
## <address>
## <city>Ä°stanbul</city>
## <country>Turkey</country>
## </address>
## </facility>
## </location>
## <location>
## <facility>
## <name>Novartis Investigative Site</name>
## <address>
## <city>Ä°zmir</city>
## <country>Turkey</country>
## </address>
## </facility>
## </location>
## <location>
## <facility>
## <name>Novartis Investigative Site</name>
## <address>
## <city>Konya</city>
## <country>Turkey</country>
## </address>
## </facility>
## </location>
## <location_countries>
## <country>Turkey</country>
## </location_countries>
## <verification_date>May 2013</verification_date>
## <lastchanged_date>May 23, 2013</lastchanged_date>
## <firstreceived_date>June 21, 2010</firstreceived_date>
## <firstreceived_results_date>April 2, 2013</firstreceived_results_date>
## <responsible_party>
## <responsible_party_type>Sponsor</responsible_party_type>
## </responsible_party>
## <keyword>Macula degeneration</keyword>
## <keyword>Ranibizumab</keyword>
## <keyword>Choroidal neovascularisation</keyword>
## <keyword>Treat and extend</keyword>
## <keyword>Treat and observe</keyword>
## <is_fda_regulated>No</is_fda_regulated>
## <has_expanded_access>No</has_expanded_access>
## <condition_browse>
## <!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
## <mesh_term>Choroidal Neovascularization</mesh_term>
## <mesh_term>Macular Degeneration</mesh_term>
## <mesh_term>Neovascularization, Pathologic</mesh_term>
## </condition_browse>
## <clinical_results>
## <participant_flow>
## <group_list>
## <group group_id="P1">
## <title>All Patients</title>
## <description>All 99 patients were exposed to study drug. 93 of the 99 patients were randomized into the Treat and Extend and the Treat and Observe treatment groups.</description>
## </group>
## <group group_id="P2">
## <title>Treat and Extend</title>
## <description>Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.</description>
## </group>
## <group group_id="P3">
## <title>Treat and Observe</title>
## <description>Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.</description>
## </group>
## </group_list>
## <period_list>
## <period>
## <title>Exposed to Study Drug</title>
## <milestone_list>
## <milestone>
## <title>STARTED</title>
## <participants_list>
## <participants group_id="P1" count="99"/>
## <participants group_id="P2" count="0">Patients were not randomized to this group until the Randomized Period.</participants>
## <participants group_id="P3" count="0">Patients were not randomized to this group until the Randomized Period.</participants>
## </participants_list>
## </milestone>
## <milestone>
## <title>COMPLETED</title>
## <participants_list>
## <participants group_id="P1" count="93"/>
## <participants group_id="P2" count="0"/>
## <participants group_id="P3" count="0"/>
## </participants_list>
## </milestone>
## <milestone>
## <title>NOT COMPLETED</title>
## <participants_list>
## <participants group_id="P1" count="6"/>
## <participants group_id="P2" count="0"/>
## <participants group_id="P3" count="0"/>
## </participants_list>
## </milestone>
## </milestone_list>
## <drop_withdraw_reason_list>
## <drop_withdraw_reason>
## <title>Protocol Violation</title>
## <participants_list>
## <participants group_id="P1" count="2"/>
## <participants group_id="P2" count="0"/>
## <participants group_id="P3" count="0"/>
## </participants_list>
## </drop_withdraw_reason>
## <drop_withdraw_reason>
## <title>Lost to Follow-up</title>
## <participants_list>
## <participants group_id="P1" count="4"/>
## <participants group_id="P2" count="0"/>
## <participants group_id="P3" count="0"/>
## </participants_list>
## </drop_withdraw_reason>
## </drop_withdraw_reason_list>
## </period>
## <period>
## <title>Randomized</title>
## <milestone_list>
## <milestone>
## <title>STARTED</title>
## <participants_list>
## <participants group_id="P1" count="0">All patients were randomized into the Treat and Extend and the Treat and Observe treatment groups.</participants>
## <participants group_id="P2" count="48"/>
## <participants group_id="P3" count="45"/>
## </participants_list>
## </milestone>
## <milestone>
## <title>COMPLETED</title>
## <participants_list>
## <participants group_id="P1" count="0"/>
## <participants group_id="P2" count="38"/>
## <participants group_id="P3" count="39"/>
## </participants_list>
## </milestone>
## <milestone>
## <title>NOT COMPLETED</title>
## <participants_list>
## <participants group_id="P1" count="0"/>
## <participants group_id="P2" count="10"/>
## <participants group_id="P3" count="6"/>
## </participants_list>
## </milestone>
## </milestone_list>
## <drop_withdraw_reason_list>
## <drop_withdraw_reason>
## <title>Adverse Event</title>
## <participants_list>
## <participants group_id="P1" count="0"/>
## <participants group_id="P2" count="1"/>
## <participants group_id="P3" count="0"/>
## </participants_list>
## </drop_withdraw_reason>
## <drop_withdraw_reason>
## <title>Protocol Violation</title>
## <participants_list>
## <participants group_id="P1" count="0"/>
## <participants group_id="P2" count="2"/>
## <participants group_id="P3" count="1"/>
## </participants_list>
## </drop_withdraw_reason>
## <drop_withdraw_reason>
## <title>Lost to Follow-up</title>
## <participants_list>
## <participants group_id="P1" count="0"/>
## <participants group_id="P2" count="1"/>
## <participants group_id="P3" count="1"/>
## </participants_list>
## </drop_withdraw_reason>
## <drop_withdraw_reason>
## <title>Consent withdrawal</title>
## <participants_list>
## <participants group_id="P1" count="0"/>
## <participants group_id="P2" count="5"/>
## <participants group_id="P3" count="3"/>
## </participants_list>
## </drop_withdraw_reason>
## <drop_withdraw_reason>
## <title>Not Specified</title>
## <participants_list>
## <participants group_id="P1" count="0"/>
## <participants group_id="P2" count="1"/>
## <participants group_id="P3" count="1"/>
## </participants_list>
## </drop_withdraw_reason>
## </drop_withdraw_reason_list>
## </period>
## </period_list>
## </participant_flow>
## <baseline>
## <population>Safety population: All patients who received study drug (n=99). Not all patients who received study drug were randomized into the 2 treatment groups (n=93) due to discontinuation from the study in the first Period of the study. Baseline Characteristics are only reported for the randomized (n=93) patients.</population>
## <group_list>
## <group group_id="B1">
## <title>Treat and Extend</title>
## <description>Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.</description>
## </group>
## <group group_id="B2">
## <title>Treat and Observe</title>
## <description>Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.</description>
## </group>
## <group group_id="B3">
## <title>Total</title>
## <description>Total of all reporting groups</description>
## </group>
## </group_list>
## <measure_list>
## <measure>
## <title>Number of Participants</title>
## <units>participants</units>
## <param>Number</param>
## <category_list>
## <category>
## <measurement_list>
## <measurement group_id="B1" value="48"/>
## <measurement group_id="B2" value="45"/>
## <measurement group_id="B3" value="93"/>
## </measurement_list>
## </category>
## </category_list>
## </measure>
## <measure>
## <title>Age</title>
## <units>years</units>
## <param>Mean</param>
## <dispersion>Standard Deviation</dispersion>
## <category_list>
## <category>
## <measurement_list>
## <measurement group_id="B1" value="70.8" spread="8.8"/>
## <measurement group_id="B2" value="71.1" spread="8.4"/>
## <measurement group_id="B3" value="70.9" spread="8.6"/>
## </measurement_list>
## </category>
## </category_list>
## </measure>
## <measure>
## <title>Gender</title>
## <units>participants</units>
## <param>Number</param>
## <category_list>
## <category>
## <sub_title>Female</sub_title>
## <measurement_list>
## <measurement group_id="B1" value="23"/>
## <measurement group_id="B2" value="20"/>
## <measurement group_id="B3" value="43"/>
## </measurement_list>
## </category>
## <category>
## <sub_title>Male</sub_title>
## <measurement_list>
## <measurement group_id="B1" value="25"/>
## <measurement group_id="B2" value="25"/>
## <measurement group_id="B3" value="50"/>
## </measurement_list>
## </category>
## </category_list>
## </measure>
## </measure_list>
## </baseline>
## <outcome_list>
## <outcome>
## <type>Primary</type>
## <title>Change in Best-Corrected Visual Acuity (logMAR) From Baseline to Month 12</title>
## <description>Best corrected visual acuity (BCVA) was assessed in the study eye. BCVA measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there are 5 letters per line, the total score for a line on the logMAR chart represents a change of 0.1 log units. The formula for calculating the logMAR BCVA score is: 0.1 + logMAR value of the best line read - 0.02 x number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.</description>
## <time_frame>Baseline to Month 12</time_frame>
## <safety_issue>No</safety_issue>
## <population>Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.</population>
## <group_list>
## <group group_id="O1">
## <title>Treat and Extend</title>
## <description>Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.</description>
## </group>
## <group group_id="O2">
## <title>Treat and Observe</title>
## <description>Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.</description>
## </group>
## </group_list>
## <measure_list>
## <measure>
## <title>Number of Participants</title>
## <units>participants</units>
## <param>Number</param>
## <category_list>
## <category>
## <measurement_list>
## <measurement group_id="O1" value="38"/>
## <measurement group_id="O2" value="39"/>
## </measurement_list>
## </category>
## </category_list>
## </measure>
## <measure>
## <title>Change in Best-Corrected Visual Acuity (logMAR) From Baseline to Month 12</title>
## <description>Best corrected visual acuity (BCVA) was assessed in the study eye. BCVA measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there are 5 letters per line, the total score for a line on the logMAR chart represents a change of 0.1 log units. The formula for calculating the logMAR BCVA score is: 0.1 + logMAR value of the best line read - 0.02 x number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.</description>
## <units>logMAR</units>
## <param>Median</param>
## <dispersion>Full Range</dispersion>
## <category_list>
## <category>
## <measurement_list>
## <measurement group_id="O1" value="-0.18" lower_limit="-0.88" upper_limit="0.76"/>
## <measurement group_id="O2" value="-0.12" lower_limit="-0.88" upper_limit="1.56"/>
## </measurement_list>
## </category>
## </category_list>
## </measure>
## </measure_list>
## </outcome>
## <outcome>
## <type>Primary</type>
## <title>Change in Letter Count From Baseline to Month 12</title>
## <description>Letter count was assessed in the study eye. Measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. A higher letter count score indicates better vision. A negative change score indicates improvement.</description>
## <time_frame>Baseline to Month 12</time_frame>
## <safety_issue>No</safety_issue>
## <population>Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.</population>
## <group_list>
## <group group_id="O1">
## <title>Treat and Extend</title>
## <description>Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.</description>
## </group>
## <group group_id="O2">
## <title>Treat and Observe</title>
## <description>Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.</description>
## </group>
## </group_list>
## <measure_list>
## <measure>
## <title>Number of Participants</title>
## <units>participants</units>
## <param>Number</param>
## <category_list>
## <category>
## <measurement_list>
## <measurement group_id="O1" value="38"/>
## <measurement group_id="O2" value="39"/>
## </measurement_list>
## </category>
## </category_list>
## </measure>
## <measure>
## <title>Change in Letter Count From Baseline to Month 12</title>
## <description>Letter count was assessed in the study eye. Measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. A higher letter count score indicates better vision. A negative change score indicates improvement.</description>
## <units>Letters</units>
## <param>Median</param>
## <dispersion>Full Range</dispersion>
## <category_list>
## <category>
## <measurement_list>
## <measurement group_id="O1" value="-9" lower_limit="-44" upper_limit="38"/>
## <measurement group_id="O2" value="-6" lower_limit="-44" upper_limit="78"/>
## </measurement_list>
## </category>
## </category_list>
## </measure>
## </measure_list>
## </outcome>
## <outcome>
## <type>Secondary</type>
## <title>Letter Count From Baseline to Month 12</title>
## <description>Letter count was assessed in the study eye. Measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. Results are reported in various categories of change in letter count.</description>
## <time_frame>Baseline to Month 12</time_frame>
## <safety_issue>No</safety_issue>
## <population>Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.</population>
## <group_list>
## <group group_id="O1">
## <title>Treat and Extend</title>
## <description>Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.</description>
## </group>
## <group group_id="O2">
## <title>Treat and Observe</title>
## <description>Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.</description>
## </group>
## </group_list>
## <measure_list>
## <measure>
## <title>Number of Participants</title>
## <units>participants</units>
## <param>Number</param>
## <category_list>
## <category>
## <measurement_list>
## <measurement group_id="O1" value="38"/>
## <measurement group_id="O2" value="39"/>
## </measurement_list>
## </category>
## </category_list>
## </measure>
## <measure>
## <title>Letter Count From Baseline to Month 12</title>
## <description>Letter count was assessed in the study eye. Measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. Results are reported in various categories of change in letter count.</description>
## <units>Percentage of patients</units>
## <param>Number</param>
## <category_list>
## <category>
## <sub_title>< 35 letters</sub_title>
## <measurement_list>
## <measurement group_id="O1" value="7.9"/>
## <measurement group_id="O2" value="7.7"/>
## </measurement_list>
## </category>
## <category>
## <sub_title>⥠35 letters</sub_title>
## <measurement_list>
## <measurement group_id="O1" value="92.1"/>
## <measurement group_id="O2" value="92.3"/>
## </measurement_list>
## </category>
## <category>
## <sub_title>loss > 15 letters</sub_title>
## <measurement_list>
## <measurement group_id="O1" value="10.5"/>
## <measurement group_id="O2" value="10.3"/>
## </measurement_list>
## </category>
## <category>
## <sub_title>loss ⤠15 letters or gained letter</sub_title>
## <measurement_list>
## <measurement group_id="O1" value="89.5"/>
## <measurement group_id="O2" value="89.7"/>
## </measurement_list>
## </category>
## <category>
## <sub_title>loss ⥠30 letters</sub_title>
## <measurement_list>
## <measurement group_id="O1" value="2.6"/>
## <measurement group_id="O2" value="5.1"/>
## </measurement_list>
## </category>
## <category>
## <sub_title>loss < 30 letters or gained letter</sub_title>
## <measurement_list>
## <measurement group_id="O1" value="97.4"/>
## <measurement group_id="O2" value="94.9"/>
## </measurement_list>
## </category>
## <category>
## <sub_title>gain ⥠0 letter</sub_title>
## <measurement_list>
## <measurement group_id="O1" value="76.3"/>
## <measurement group_id="O2" value="61.5"/>
## </measurement_list>
## </category>
## <category>
## <sub_title>Loss</sub_title>
## <measurement_list>
## <measurement group_id="O1" value="23.7"/>
## <measurement group_id="O2" value="38.5"/>
## </measurement_list>
## </category>
## <category>
## <sub_title>gain ⥠15 letter</sub_title>
## <measurement_list>
## <measurement group_id="O1" value="34.2"/>
## <measurement group_id="O2" value="23.1"/>
## </measurement_list>
## </category>
## <category>
## <sub_title>gain < 15 letters or loss</sub_title>
## <measurement_list>
## <measurement group_id="O1" value="65.8"/>
## <measurement group_id="O2" value="76.9"/>
## </measurement_list>
## </category>
## </category_list>
## </measure>
## </measure_list>
## </outcome>
## <outcome>
## <type>Secondary</type>
## <title>Number of Visits</title>
## <time_frame>Baseline to Month 12</time_frame>
## <safety_issue>No</safety_issue>
## <population>Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.</population>
## <group_list>
## <group group_id="O1">
## <title>Treat and Extend</title>
## <description>Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.</description>
## </group>
## <group group_id="O2">
## <title>Treat and Observe</title>
## <description>Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.</description>
## </group>
## </group_list>
## <measure_list>
## <measure>
## <title>Number of Participants</title>
## <units>participants</units>
## <param>Number</param>
## <category_list>
## <category>
## <measurement_list>
## <measurement group_id="O1" value="38"/>
## <measurement group_id="O2" value="39"/>
## </measurement_list>
## </category>
## </category_list>
## </measure>
## <measure>
## <title>Number of Visits</title>
## <units>Visits</units>
## <param>Median</param>
## <dispersion>Full Range</dispersion>
## <category_list>
## <category>
## <measurement_list>
## <measurement group_id="O1" value="12.0" lower_limit="10.0" upper_limit="15.0"/>
## <measurement group_id="O2" value="15.0" lower_limit="12.0" upper_limit="15.0"/>
## </measurement_list>
## </category>
## </category_list>
## </measure>
## </measure_list>
## </outcome>
## <outcome>
## <type>Secondary</type>
## <title>Follow-up Duration</title>
## <description>Follow-up duration was defined as the number of days from Baseline to study discontinuation.</description>
## <time_frame>Baseline to Month 12</time_frame>
## <safety_issue>No</safety_issue>
## <population>Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.</population>
## <group_list>
## <group group_id="O1">
## <title>Treat and Extend</title>
## <description>Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.</description>
## </group>
## <group group_id="O2">
## <title>Treat and Observe</title>
## <description>Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.</description>
## </group>
## </group_list>
## <measure_list>
## <measure>
## <title>Number of Participants</title>
## <units>participants</units>
## <param>Number</param>
## <category_list>
## <category>
## <measurement_list>
## <measurement group_id="O1" value="38"/>
## <measurement group_id="O2" value="39"/>
## </measurement_list>
## </category>
## </category_list>
## </measure>
## <measure>
## <title>Follow-up Duration</title>
## <description>Follow-up duration was defined as the number of days from Baseline to study discontinuation.</description>
## <units>Days</units>
## <param>Mean</param>
## <dispersion>Full Range</dispersion>
## <category_list>
## <category>
## <measurement_list>
## <measurement group_id="O1" value="364.5" lower_limit="310.0" upper_limit="396.0"/>
## <measurement group_id="O2" value="366.0" lower_limit="320.0" upper_limit="386.0"/>
## </measurement_list>
## </category>
## </category_list>
## </measure>
## </measure_list>
## </outcome>
## <outcome>
## <type>Secondary</type>
## <title>Change in Central Retinal Thickness From Baseline to Month 12</title>
## <description>Retinal thickness was measured using Optical Coherence Tomography (OCT).</description>
## <time_frame>Baseline to Month 12</time_frame>
## <safety_issue>No</safety_issue>
## <population>Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.</population>
## <group_list>
## <group group_id="O1">
## <title>Treat and Extend</title>
## <description>Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.</description>
## </group>
## <group group_id="O2">
## <title>Treat and Observe</title>
## <description>Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.</description>
## </group>
## </group_list>
## <measure_list>
## <measure>
## <title>Number of Participants</title>
## <units>participants</units>
## <param>Number</param>
## <category_list>
## <category>
## <measurement_list>
## <measurement group_id="O1" value="38"/>
## <measurement group_id="O2" value="39"/>
## </measurement_list>
## </category>
## </category_list>
## </measure>
## <measure>
## <title>Change in Central Retinal Thickness From Baseline to Month 12</title>
## <description>Retinal thickness was measured using Optical Coherence Tomography (OCT).</description>
## <units>µm</units>
## <param>Median</param>
## <dispersion>Full Range</dispersion>
## <category_list>
## <category>
## <measurement_list>
## <measurement group_id="O1" value="88.5" lower_limit="-190.0" upper_limit="584.0"/>
## <measurement group_id="O2" value="61.0" lower_limit="-470.0" upper_limit="500.0"/>
## </measurement_list>
## </category>
## </category_list>
## </measure>
## </measure_list>
## </outcome>
## <outcome>
## <type>Secondary</type>
## <title>Quality of Life</title>
## <description>The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure a patientâs subjective assessment of vision-related quality of life at Visits 2, 6, 9, 12, and 15. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated poorer function.</description>
## <time_frame>Visits 2, 6, 9, 12, and 15 (up to 12 months)</time_frame>
## <safety_issue>No</safety_issue>
## <population>Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.</population>
## <group_list>
## <group group_id="O1">
## <title>Treat and Extend</title>
## <description>Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.</description>
## </group>
## <group group_id="O2">
## <title>Treat and Observe</title>
## <description>Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.</description>
## </group>
## </group_list>
## <measure_list>
## <measure>
## <title>Number of Participants</title>
## <units>participants</units>
## <param>Number</param>
## <category_list>
## <category>
## <measurement_list>
## <measurement group_id="O1" value="27"/>
## <measurement group_id="O2" value="30"/>
## </measurement_list>
## </category>
## </category_list>
## </measure>
## <measure>
## <title>Quality of Life</title>
## <description>The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure a patientâs subjective assessment of vision-related quality of life at Visits 2, 6, 9, 12, and 15. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated poorer function.</description>
## <units>Units on a scale</units>
## <param>Median</param>
## <dispersion>Full Range</dispersion>
## <category_list>
## <category>
## <sub_title>Visit 2</sub_title>
## <measurement_list>
## <measurement group_id="O1" value="70.0" lower_limit="57.0" upper_limit="87.0"/>
## <measurement group_id="O2" value="73.0" lower_limit="62.0" upper_limit="89.0"/>
## </measurement_list>
## </category>
## <category>
## <sub_title>Visit 6</sub_title>
## <measurement_list>
## <measurement group_id="O1" value="71.0" lower_limit="65.0" upper_limit="83.0"/>
## <measurement group_id="O2" value="69.5" lower_limit="60.0" upper_limit="79.0"/>
## </measurement_list>
## </category>
## <category>
## <sub_title>Visit 9</sub_title>
## <measurement_list>
## <measurement group_id="O1" value="69.0" lower_limit="63.0" upper_limit="80.0"/>
## <measurement group_id="O2" value="72.5" lower_limit="62.0" upper_limit="92.0"/>
## </measurement_list>
## </category>
## <category>
## <sub_title>Visit 12</sub_title>
## <measurement_list>
## <measurement group_id="O1" value="72.0" lower_limit="64.0" upper_limit="84.0"/>
## <measurement group_id="O2" value="71.0" lower_limit="60.0" upper_limit="91.0"/>
## </measurement_list>
## </category>
## <category>
## <sub_title>Visit 15</sub_title>
## <measurement_list>
## <measurement group_id="O1" value="69.0" lower_limit="64.0" upper_limit="80.0"/>
## <measurement group_id="O2" value="70.5" lower_limit="57.0" upper_limit="85.0"/>
## </measurement_list>
## </category>
## </category_list>
## </measure>
## </measure_list>
## </outcome>
## </outcome_list>
## <reported_events>
## <desc>Safety population: All patients who received study drug.</desc>
## <group_list>
## <group group_id="E1">
## <title>Treat and Extend</title>
## <description>Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.</description>
## </group>
## <group group_id="E2">
## <title>Treat and Observe</title>
## <description>Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.</description>
## </group>
## <group group_id="E3">
## <title>Before Randomization</title>
## <description>These 6 patients were exposed to study drug but discontinued from the study prior to randomization.</description>
## </group>
## </group_list>
## <serious_events>
## <default_vocab>MedDRA</default_vocab>
## <default_assessment>Systematic Assessment</default_assessment>
## <category_list>
## <category>
## <title>Total</title>
## <event_list>
## <event>
## <sub_title>Total, serious adverse events</sub_title>
## <counts group_id="E1" subjects_affected="5" subjects_at_risk="48"/>
## <counts group_id="E2" subjects_affected="3" subjects_at_risk="45"/>
## <counts group_id="E3" subjects_affected="2" subjects_at_risk="6"/>
## </event>
## </event_list>
## </category>
## <category>
## <title>Cardiac disorders</title>
## <event_list>
## <event>
## <sub_title>Arrhythmia</sub_title>
## <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
## <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
## <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
## </event>
## <event>
## <sub_title>Mitral valve incompetence</sub_title>
## <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
## <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
## <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
## </event>
## </event_list>
## </category>
## <category>
## <title>Gastrointestinal disorders</title>
## <event_list>
## <event>
## <sub_title>Diarrhea</sub_title>
## <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
## <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
## <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
## </event>
## </event_list>
## </category>
## <category>
## <title>Musculoskeletal and connective tissue disorders</title>
## <event_list>
## <event>
## <sub_title>Lower and upper limb fracture</sub_title>
## <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
## <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
## <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
## </event>
## </event_list>
## </category>
## <category>
## <title>Psychiatric disorders</title>
## <event_list>
## <event>
## <sub_title>Aphasia Syncope</sub_title>
## <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
## <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
## <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
## </event>
## </event_list>
## </category>
## <category>
## <title>Renal and urinary disorders</title>
## <event_list>
## <event>
## <sub_title>Azotemia</sub_title>
## <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
## <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
## <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
## </event>
## </event_list>
## </category>
## <category>
## <title>Respiratory, thoracic and mediastinal disorders</title>
## <event_list>
## <event>
## <sub_title>Asthma</sub_title>
## <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
## <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
## <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
## </event>
## </event_list>
## </category>
## <category>
## <title>Skin and subcutaneous tissue disorders</title>
## <event_list>
## <event>
## <sub_title>Herpes zoster</sub_title>
## <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
## <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
## <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
## </event>
## </event_list>
## </category>
## <category>
## <title>Surgical and medical procedures</title>
## <event_list>
## <event>
## <sub_title>Vascular graft</sub_title>
## <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
## <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
## <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
## </event>
## </event_list>
## </category>
## </category_list>
## </serious_events>
## <other_events>
## <frequency_threshold>5</frequency_threshold>
## <default_vocab>MedDRA</default_vocab>
## <default_assessment>Systematic Assessment</default_assessment>
## <category_list>
## <category>
## <title>Total</title>
## <event_list>
## <event>
## <sub_title>Total, other adverse events</sub_title>
## <counts group_id="E1" subjects_affected="10" subjects_at_risk="48"/>
## <counts group_id="E2" subjects_affected="8" subjects_at_risk="45"/>
## <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
## </event>
## </event_list>
## </category>
## <category>
## <title>Eye disorders</title>
## <event_list>
## <event>
## <sub_title>Adenoviral conjunctivitis</sub_title>
## <counts group_id="E1" subjects_affected="2" subjects_at_risk="48"/>
## <counts group_id="E2" subjects_affected="3" subjects_at_risk="45"/>
## <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
## </event>
## </event_list>
## </category>
## <category>
## <title>Respiratory, thoracic and mediastinal disorders</title>
## <event_list>
## <event>
## <sub_title>Influenza</sub_title>
## <counts group_id="E1" subjects_affected="8" subjects_at_risk="48"/>
## <counts group_id="E2" subjects_affected="5" subjects_at_risk="45"/>
## <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
## </event>
## </event_list>
## </category>
## <category>
## <title>Vascular disorders</title>
## <event_list>
## <event>
## <sub_title>Hypertension</sub_title>
## <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
## <counts group_id="E2" subjects_affected="2" subjects_at_risk="45"/>
## <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
## </event>
## </event_list>
## </category>
## </category_list>
## </other_events>
## </reported_events>
## <certain_agreements>
## <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
## <restrictive_agreement>The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.</restrictive_agreement>
## </certain_agreements>
## <point_of_contact>
## <name_or_title>Study Director</name_or_title>
## <organization>Novartis Pharmaceuticals</organization>
## <phone>862 778-8300</phone>
## </point_of_contact>
## </clinical_results>
## </clinical_study>
## xpath='//brief_summary/textblock'
#trick to print and assign at the same time
(ns <- getNodeSet(xml, xpath))## [[1]]
## <textblock>
## The purpose of the study was to compare 2 treatment regimens for patients suffering from
## choroidal neovascularisation secondary to age-related macular degeneration (AMD). The first
## treatment regimen was the approved AMD treatment of 1 injection each month for 3 months and
## than re-treatment of patients who have a visual loss of more than 5 letters with monthly
## control (Treat and Observe). The second treatment regimen was 1 injection each month for 3
## months and than extending the control period if the macula is dry during the monthly control
## (Treat and Extend). If the "Treat and Extend" regimen is found effective and safe, the
## number of ranibizumab injections, the number of patient visits, the risk of adverse events
## due to the intravitreal injections, and policlinic occupation number could all be reduced.
## </textblock>
##
## attr(,"class")
## [1] "XMLNodeSet" #sapply works on a list and returns a vector
#xml version of that function does that for a XML object
briefSummary<-xmlSApply(ns,xmlValue)
cat(briefSummary)##
## The purpose of the study was to compare 2 treatment regimens for patients suffering from
## choroidal neovascularisation secondary to age-related macular degeneration (AMD). The first
## treatment regimen was the approved AMD treatment of 1 injection each month for 3 months and
## than re-treatment of patients who have a visual loss of more than 5 letters with monthly
## control (Treat and Observe). The second treatment regimen was 1 injection each month for 3
## months and than extending the control period if the macula is dry during the monthly control
## (Treat and Extend). If the "Treat and Extend" regimen is found effective and safe, the
## number of ranibizumab injections, the number of patient visits, the risk of adverse events
## due to the intravitreal injections, and policlinic occupation number could all be reduced.
## #put it into clipboard for simple pasting
cat(briefSummary,file='clipboard') #loop
for (i in 1:nrow(ctdata)) {
# for (i in 1:100) {
nct=as.character(ctdata$NCT.Number[i]); nct
url=sprintf('http://ClinicalTrials.gov/show/%s?resultsxml=true',nct)
print(url)
#read the XML from internet
xml = xmlTreeParse(url,useInternalNode=TRUE)
ctdata[i,'brief_summary']<-xmlSApply(getNodeSet(xml,'//brief_summary/textblock'),xmlValue)
}## [1] "http://ClinicalTrials.gov/show/NCT01148511?resultsxml=true"
## [1] "http://ClinicalTrials.gov/show/NCT01810042?resultsxml=true"
## [1] "http://ClinicalTrials.gov/show/NCT00674323?resultsxml=true"
## [1] "http://ClinicalTrials.gov/show/NCT00473642?resultsxml=true" str(ctdata)## 'data.frame': 4 obs. of 2 variables:
## $ NCT.Number : Factor w/ 4 levels "NCT00473642",..: 3 4 2 1
## $ brief_summary: chr "\n The purpose of the study was to compare 2 treatment regimens for patients suffering from\n choroidal neovascularis"| __truncated__ "\n Exudative age-related macular degeneration (ARMD) is complicated by choroidal\n neovascularization (CNV). Although"| __truncated__ "\n This study aims to compare the efficacy of ranibizumab and verteporfin PDT combination\n treatment and verteporfin"| __truncated__ "\n In this pilot study the researchers will evaluate the safety and efficacy of 50% reduced\n fluence PDT combination"| __truncated__ library(dplyr)##
## Attaching package: 'dplyr'
##
## The following objects are masked from 'package:data.table':
##
## between, last
##
## The following objects are masked from 'package:stats':
##
## filter, lag
##
## The following objects are masked from 'package:base':
##
## intersect, setdiff, setequal, union glimpse(ctdata)## Observations: 4
## Variables: 2
## $ NCT.Number (fctr) NCT01148511, NCT01810042, NCT00674323, NCT00473642
## $ brief_summary (chr) "\n The purpose of the study was to compare... #this will be too long
ctdata$brief_summary## [1] "\n The purpose of the study was to compare 2 treatment regimens for patients suffering from\n choroidal neovascularisation secondary to age-related macular degeneration (AMD). The first\n treatment regimen was the approved AMD treatment of 1 injection each month for 3 months and\n than re-treatment of patients who have a visual loss of more than 5 letters with monthly\n control (Treat and Observe). The second treatment regimen was 1 injection each month for 3\n months and than extending the control period if the macula is dry during the monthly control\n (Treat and Extend). If the \"Treat and Extend\" regimen is found effective and safe, the\n number of ranibizumab injections, the number of patient visits, the risk of adverse events\n due to the intravitreal injections, and policlinic occupation number could all be reduced.\n "
## [2] "\n Exudative age-related macular degeneration (ARMD) is complicated by choroidal\n neovascularization (CNV). Although anti-vascular endothelial growth factor treatment is the\n gold standard treatment, recurrence is the main limitation of the treatment. The changes of\n the CNV vascular structure is expected to provide information regarding recurrence. In the\n eyes that the vascular structure is clearly seen in indocyanine green angiography (ICGA),\n the vascular changes after ranibizumab injections will be investigated prospectively.\n "
## [3] "\n This study aims to compare the efficacy of ranibizumab and verteporfin PDT combination\n treatment and verteporfin PDT monotherapy vs.ranibizumab monotherapy alone in achieving\n complete regression of polyps in patients with symptomatic macular polypoidal choroidal\n vasculopathy.\n "
## [4] "\n In this pilot study the researchers will evaluate the safety and efficacy of 50% reduced\n fluence PDT combination therapy with ranibizumab. The researchers hope to gain information\n regarding the use of reduced fluence PDT combination therapy. The information gained from\n this pilot study may prompt further definitive studies comparing the safety and efficacy of\n both standard fluence PDT combination therapy, reduced fluence PDT combination therapy, and\n ranibizumab monotherapy.\n\n The study will compare the use of combination therapy with ranibizumab and verteporfin PDT\n to ranibizumab alone in patients with exudative age-related macular degeneration (AMD). All\n patients will receive three consecutive monthly treatments with ranibizumab. Patients will\n be randomized 1:1:1 to 3 groups. Patients randomized to group 1 will receive only\n ranibizumab. Patients randomized to group 2 will also receive one treatment with reduced\n fluence (50% fluence) verteporfin PDT at day 0. Patients randomized to group 3 will also\n receive one treatment with standard fluence verteporfin PDT. All patients will also be\n evaluated for possible retreatment with ranibizumab and verteporfin PDT according to\n established criteria. Thirty patients will be recruited from one U.S. sites. Randomization\n will occur at the time of entry into the study. Follow-up will continue until month 12 (from\n day 0) in all subjects.\n " #better view
library(pander);panderOptions('table.split.table', Inf);options(knitr.table.format = 'pandoc');panderOptions("table.alignment.default", "left")
pander(ctdata)| NCT.Number | brief_summary |
|---|---|
| NCT01148511 | The purpose of the study was to compare 2 treatment regimens for patients suffering from choroidal neovascularisation secondary to age-related macular degeneration (AMD). The first treatment regimen was the approved AMD treatment of 1 injection each month for 3 months and than re-treatment of patients who have a visual loss of more than 5 letters with monthly control (Treat and Observe). The second treatment regimen was 1 injection each month for 3 months and than extending the control period if the macula is dry during the monthly control (Treat and Extend). If the “Treat and Extend” regimen is found effective and safe, the number of ranibizumab injections, the number of patient visits, the risk of adverse events due to the intravitreal injections, and policlinic occupation number could all be reduced. |
| NCT01810042 | Exudative age-related macular degeneration (ARMD) is complicated by choroidal neovascularization (CNV). Although anti-vascular endothelial growth factor treatment is the gold standard treatment, recurrence is the main limitation of the treatment. The changes of the CNV vascular structure is expected to provide information regarding recurrence. In the eyes that the vascular structure is clearly seen in indocyanine green angiography (ICGA), the vascular changes after ranibizumab injections will be investigated prospectively. |
| NCT00674323 | This study aims to compare the efficacy of ranibizumab and verteporfin PDT combination treatment and verteporfin PDT monotherapy vs.ranibizumab monotherapy alone in achieving complete regression of polyps in patients with symptomatic macular polypoidal choroidal vasculopathy. |
| NCT00473642 | In this pilot study the researchers will evaluate the safety and efficacy of 50% reduced fluence PDT combination therapy with ranibizumab. The researchers hope to gain information regarding the use of reduced fluence PDT combination therapy. The information gained from this pilot study may prompt further definitive studies comparing the safety and efficacy of both standard fluence PDT combination therapy, reduced fluence PDT combination therapy, and ranibizumab monotherapy. The study will compare the use of combination therapy with ranibizumab and verteporfin PDT to ranibizumab alone in patients with exudative age-related macular degeneration (AMD). All patients will receive three consecutive monthly treatments with ranibizumab. Patients will be randomized 1:1:1 to 3 groups. Patients randomized to group 1 will receive only ranibizumab. Patients randomized to group 2 will also receive one treatment with reduced fluence (50% fluence) verteporfin PDT at day 0. Patients randomized to group 3 will also receive one treatment with standard fluence verteporfin PDT. All patients will also be evaluated for possible retreatment with ranibizumab and verteporfin PDT according to established criteria. Thirty patients will be recruited from one U.S. sites. Randomization will occur at the time of entry into the study. Follow-up will continue until month 12 (from day 0) in all subjects. |
#export for later
write.csv(ctdata,file='ctdata.csv')
#make the data shorter
library(stringr)
ctdata$brief_summary<-str_sub(ctdata$brief_summary,1,45)
ctdata ## NCT.Number brief_summary
## 1 NCT01148511 \n The purpose of the study was to compar
## 2 NCT01810042 \n Exudative age-related macular degenera
## 3 NCT00674323 \n This study aims to compare the efficac
## 4 NCT00473642 \n In this pilot study the researchers wi xpath='/clinical_study/clinical_results/reported_events/group_list/group'
#trick to print and assign at the same time
(ns <- getNodeSet(xml, xpath))## [[1]]
## <group group_id="E1">
## <title>Standard Fluence PDT</title>
## <description>Standard Fluence Photodynamic Therapy combined with ranibizumab</description>
## </group>
##
## [[2]]
## <group group_id="E2">
## <title>50% Fluence PDT</title>
## <description>Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab</description>
## </group>
##
## [[3]]
## <group group_id="E3">
## <title>Ranibizumab</title>
## <description>Ranibizumab monotherapy</description>
## </group>
##
## attr(,"class")
## [1] "XMLNodeSet" #convert to data frame (not always works)
df <- xmlToDataFrame(nodes=ns)
#nicer output of a data.frame in r markdown report
pander(df)| title | description |
|---|---|
| Standard Fluence PDT | Standard Fluence Photodynamic Therapy combined with ranibizumab |
| 50% Fluence PDT | Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab |
| Ranibizumab | Ranibizumab monotherapy |
Here we domonstrate a more complex example, parsing to data frame is harder
xpath='/clinical_study/clinical_results/reported_events/serious_events/category_list/category/event_list/event/sub_title'
#trick to print and assign at the same time
(ns <- getNodeSet(xml, xpath))## [[1]]
## <sub_title>Total, serious adverse events</sub_title>
##
## [[2]]
## <sub_title>ACUTE MYOCARDIAL INFARCTION</sub_title>
##
## [[3]]
## <sub_title>cardiopulmonary arrest</sub_title>
##
## attr(,"class")
## [1] "XMLNodeSet" ns## [[1]]
## <sub_title>Total, serious adverse events</sub_title>
##
## [[2]]
## <sub_title>ACUTE MYOCARDIAL INFARCTION</sub_title>
##
## [[3]]
## <sub_title>cardiopulmonary arrest</sub_title>
##
## attr(,"class")
## [1] "XMLNodeSet" df <- xmlToDataFrame(nodes=ns)
#serious events
df## text
## 1 Total, serious adverse events
## 2 ACUTE MYOCARDIAL INFARCTION
## 3 cardiopulmonary arrest nrow(df)## [1] 3 if (nrow(df)>0) {
print('do something fancy here')
xpath='/clinical_study/clinical_results/reported_events/serious_events/category_list/category/event_list/event'
#trick to print and assign at the same time
length(ns)
ns <- getNodeSet(xml, xpath)
ns
} #end of if for several AEs## [1] "do something fancy here"## [[1]]
## <event>
## <sub_title>Total, serious adverse events</sub_title>
## <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
## <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
## <counts group_id="E3" subjects_affected="2" subjects_at_risk="10"/>
## </event>
##
## [[2]]
## <event>
## <sub_title>ACUTE MYOCARDIAL INFARCTION</sub_title>
## <description>greater than 2 months after last ranibizumab</description>
## <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
## <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
## <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
## </event>
##
## [[3]]
## <event>
## <sub_title>cardiopulmonary arrest</sub_title>
## <description>following hip fracture and complications greater than 2 months after ranibizumab</description>
## <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
## <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
## <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
## </event>
##
## attr(,"class")
## [1] "XMLNodeSet" #url of the trial we are experimenting with
url## [1] "http://ClinicalTrials.gov/show/NCT00473642?resultsxml=true" #in R markdown - inline use of R I could write: This is the URL: `r url` that we usedThis is the URL: http://ClinicalTrials.gov/show/NCT00473642?resultsxml=true that we used