Trial Outcomes & Findings for Pediatric Catheter-related Thrombosis Imaging Study (NCT NCT01137578)

Last Updated: 2014-12-15

Results Overview

One set of 3 diagnostic imaging procedures (US, MRI with contrast, and MRI without contrast) was performed for all cohorts. Imaging was performed on Visit 1, which in Cohort A was Day 40 ± 20 days from Day 0, the placement of the central venous catheter (CVC), or if possible within 72 hours after a CVC was removed or lost; Visit 1 in Cohort B was within 7 days of initiation of symptoms of a CVC-related deep vein thromboembolism (DVT) or within 7 days of an incidental diagnosis of CVC-related DVT by radiographic imaging. Cohort C participants had an ultrasound done within 48 hours of the performance of the MRI, which was scheduled for a clinical reason. Note: participants completing each MRI procedure (with contrast or without contrast) could be different participants.

Recruitment status

COMPLETED

Study phase

Target enrollment

151 participants

Primary outcome timeframe

Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C).

Results posted on

2014-12-15

Participant Flow

Study initiated: 28 February 2011; Study Completed: 10 May 2013. Patients with central venous catheter (CVC) in-place or planned were enrolled. The Study was diagnostic for venous thromboembolism (VTE) and was non-therapeutic.

151 participants enrolled; 134 had at least one study-related diagnostic imaging procedure completed or partially completed; 17 enrolled but not identified to a cohort and no study-related imaging procedures performed: Adverse event (2), withdrew consent (1), lost to follow up (1), poor/non-compliance (1), no longer met criteria (3), other (9).

Participant milestones

Participant milestones
Measure	Cohort A Cohort A included pediatric participants (full-term newborns to \<18 years) in which a CVC was recently placed and who were asymptomatic for CVC-related deep vein thrombosis (DVT). Imaging procedures occurred on Day 40 ± 20 days relative to catheter placement (Day 0) and included: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered 'state-of-the-art' or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used for MRI with contrast. No sedation or anesthesia was to be allowed. Participants who developed symptoms of VTE prior to imaging should have been switched to Cohort B.	Cohort B Cohort B included pediatric participants (full-term newborns to \<18 years) with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT based on radiographic imaging performed for other clinical reasons. Diagnostic imaging procedures, US and MRI (with and without gadolinium contrast enhancement) were to be done within 48 hours of each other or, for those with therapeutic anticoagulation, within 24 hours. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT.	Sub-Study Cohort C A Sub-study with additional cohort C was initiated to collect diagnostic imaging procedures for the detection of CVC-related DVT in a population \< 18 years of age who had a CVC in place and who were scheduled to undergo a contrast enhanced MRI in any part of their body as part of their clinical care and who allowed the diagnostic imaging procedure to include the area around the CVC. Participants who developed symptoms of VTE prior to imaging should have been switched to Cohort B.
Overall Study STARTED	77	14	43
Overall Study COMPLETED	61	12	37
Overall Study NOT COMPLETED	16	2	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort A Cohort A included pediatric participants (full-term newborns to \<18 years) in which a CVC was recently placed and who were asymptomatic for CVC-related deep vein thrombosis (DVT). Imaging procedures occurred on Day 40 ± 20 days relative to catheter placement (Day 0) and included: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered 'state-of-the-art' or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used for MRI with contrast. No sedation or anesthesia was to be allowed. Participants who developed symptoms of VTE prior to imaging should have been switched to Cohort B.	Cohort B Cohort B included pediatric participants (full-term newborns to \<18 years) with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT based on radiographic imaging performed for other clinical reasons. Diagnostic imaging procedures, US and MRI (with and without gadolinium contrast enhancement) were to be done within 48 hours of each other or, for those with therapeutic anticoagulation, within 24 hours. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT.	Sub-Study Cohort C A Sub-study with additional cohort C was initiated to collect diagnostic imaging procedures for the detection of CVC-related DVT in a population \< 18 years of age who had a CVC in place and who were scheduled to undergo a contrast enhanced MRI in any part of their body as part of their clinical care and who allowed the diagnostic imaging procedure to include the area around the CVC. Participants who developed symptoms of VTE prior to imaging should have been switched to Cohort B.
Overall Study Participant requested to Discontinue	3	0	0
Overall Study Withdrawal by Subject	1	0	0
Overall Study Other	12	2	6

Baseline Characteristics

Pediatric Catheter-related Thrombosis Imaging Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Imaged Participants n=134 Participants Baseline parameters for all participants in Cohorts A, B, and C: Pediatric participants (full-term newborns to \<18 years) in which a CVC was to be placed or who had a CVC in place. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related deep vein thrombosis (DVT) or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
Age, Continuous	9.9 years STANDARD_DEVIATION 4.89 • n=5 Participants
Age, Customized Less than (<) 2 years	7 participants n=5 Participants
Age, Customized Between 2 years and <12 years	64 participants n=5 Participants
Age, Customized Between 12 years and <18 years	63 participants n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants
Sex: Female, Male Male	78 Participants n=5 Participants
Race/Ethnicity, Customized White	117 participants n=5 Participants
Race/Ethnicity, Customized Black/African American	7 participants n=5 Participants
Race/Ethnicity, Customized Asian	3 participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska native	3 participants n=5 Participants
Race/Ethnicity, Customized Other	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C).

Population: The imaged population included all enrolled participants who had at least 1 study-related diagnostic imaging procedure.

Outcome measures

Outcome measures
Measure	All Imaged Participants n=134 Participants All participants in Cohorts A, B, and C who had at least 1 radiographic procedure: Pediatric participants (full-term newborns to \<18 years) in which a CVC was to be placed or who had a CVC in place. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related deep vein thrombosis (DVT) or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).	Cohort A 2Years to <12Years Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered 'state-of-the-art' or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.	Cohort A 12Years to <18Years Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered 'state-of-the-art' or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.	Cohort B Newborn to <2Years Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.	Cohort B 2Years to <12Years Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.	Cohort B 12Years to <18Years Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.	Cohort C Newborn to <2Years Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.	Cohort C 2Years to <12Years Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.	Cohort C 12Years to <18Years Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
Total Number of Participants Who Completed the Study-Related Ultrasound (US) and Magnetic Resonance Imaging (MRI) With and Without Contrast Completed Ultrasound	133 participants	—	—	—	—	—	—	—	—
Total Number of Participants Who Completed the Study-Related Ultrasound (US) and Magnetic Resonance Imaging (MRI) With and Without Contrast Completed the MRI with Contrast	113 participants	—	—	—	—	—	—	—	—
Total Number of Participants Who Completed the Study-Related Ultrasound (US) and Magnetic Resonance Imaging (MRI) With and Without Contrast Completed the MRI without Contrast	113 participants	—	—	—	—	—	—	—	—
Total Number of Participants Who Completed the Study-Related Ultrasound (US) and Magnetic Resonance Imaging (MRI) With and Without Contrast Completed All 3 Imaging Procedures	110 participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Population: The imaged population included all enrolled participants who had at least 1 study-related diagnostic imaging procedure.

Imaging was performed on Visit 1 which was defined for Cohort A as: Day 40 ± 20 days from Day 0, the placement of the central venous catheter (CVC), or if possible within 72 hours after a CVC was removed or lost; Visit 1 defined for Cohort B: within 7 days of initiation of symptoms of a CVC-related deep vein thromboembolism (DVT) or within 7 days of an incidental diagnosis of CVC-related DVT by radiographic imaging. Cohort C participants had an ultrasound done within 48 hours of the performance of the MRI. All 3 imaging procedures, ultrasound, MRI with contrast, MRI without contrast were to be performed on all participants, regardless of the cohort.

Outcome measures

Outcome measures
Measure	All Imaged Participants n=2 Participants All participants in Cohorts A, B, and C who had at least 1 radiographic procedure: Pediatric participants (full-term newborns to \<18 years) in which a CVC was to be placed or who had a CVC in place. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related deep vein thrombosis (DVT) or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).	Cohort A 2Years to <12Years n=30 Participants Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered 'state-of-the-art' or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.	Cohort A 12Years to <18Years n=45 Participants Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered 'state-of-the-art' or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.	Cohort B Newborn to <2Years n=1 Participants Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.	Cohort B 2Years to <12Years n=6 Participants Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.	Cohort B 12Years to <18Years n=7 Participants Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.	Cohort C Newborn to <2Years n=4 Participants Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.	Cohort C 2Years to <12Years n=28 Participants Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.	Cohort C 12Years to <18Years n=11 Participants Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group US and MRI with contrast Completed	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants
Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group US and MRI without contrast Completed	0 participants	0 participants	1 participants	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants
Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group MRI with and without contrast Completed	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants
Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group All 3 Imaging Procedures Completed	1 participants	22 participants	38 participants	1 participants	5 participants	6 participants	3 participants	24 participants	10 participants
Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group Only Ultrasound Completed	1 participants	7 participants	6 participants	0 participants	1 participants	0 participants	1 participants	3 participants	0 participants
Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group Only MRI with contrast Completed	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group Only MRI without contrast Completed	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

PRIMARY outcome

Population: The imaged population included all participants who had at least 1 study-related diagnostic imaging procedure.

One set of diagnostic imaging procedures (US and MRI) was to be performed for all cohorts The MRI consisted of MRI venous imaging without contrast enhancement and MRI venous imaging with contrast enhancement.

Outcome measures

Outcome measures
Measure	All Imaged Participants n=32 Participants All participants in Cohorts A, B, and C who had at least 1 radiographic procedure: Pediatric participants (full-term newborns to \<18 years) in which a CVC was to be placed or who had a CVC in place. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related deep vein thrombosis (DVT) or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).	Cohort A 2Years to <12Years n=45 Participants Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered 'state-of-the-art' or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.	Cohort A 12Years to <18Years n=7 Participants Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered 'state-of-the-art' or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.	Cohort B Newborn to <2Years n=7 Participants Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.	Cohort B 2Years to <12Years n=32 Participants Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.	Cohort B 12Years to <18Years n=11 Participants Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.	Cohort C Newborn to <2Years Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.	Cohort C 2Years to <12Years Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.	Cohort C 12Years to <18Years Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
Number of Participants Who Required Sedation/Anesthesia With the Study-Related Radiographic Procedures, by Cohort and Age Required Sedation for MRI	0 participants	0 participants	1 participants	0 participants	17 participants	0 participants	—	—	—
Number of Participants Who Required Sedation/Anesthesia With the Study-Related Radiographic Procedures, by Cohort and Age Required Sedation for US	0 participants	0 participants	0 participants	0 participants	3 participants	0 participants	—	—	—

PRIMARY outcome

Population: Participants had at least 1 radiographic procedure performed but were unable to complete a either an Ultrasound (neither bilateral or unilateral, or could complete only a unilateral US) and/or unable to complete an MRI with contrast and/or unable to complete an MRI without contrast.

Bilateral US was attempted but if it could not be completed, a unilateral US was accepted for analysis. Participants who did not complete the MRI procedure with contrast could be different participants from those who did not complete the MRI procedure without contrast. Primary reasons for non-completion of imaging included: technical, investigator decision, child refused, parent refused, child missed appointment, difficulties with anesthesia/sedation, child unable to lie still, problems with contrast administration, and other reasons. Other reasons could include: late to appointment and unable to perform MRI due to time constraints; logistical reasons, parent agreed to only ultrasound at time of consent, schedule delay, equipment not available, difficulty putting patient in correct position. Due to the small numbers of participants in some cohorts, these data were more meaningful with all cohorts grouped together for the total imaged population.

Outcome measures

Outcome measures
Measure	All Imaged Participants n=1 Participants All participants in Cohorts A, B, and C who had at least 1 radiographic procedure: Pediatric participants (full-term newborns to \<18 years) in which a CVC was to be placed or who had a CVC in place. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related deep vein thrombosis (DVT) or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).	Cohort A 2Years to <12Years n=9 Participants Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered 'state-of-the-art' or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.	Cohort A 12Years to <18Years n=21 Participants Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered 'state-of-the-art' or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.	Cohort B Newborn to <2Years n=21 Participants Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.	Cohort B 2Years to <12Years Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.	Cohort B 12Years to <18Years Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.	Cohort C Newborn to <2Years Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.	Cohort C 2Years to <12Years Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.	Cohort C 12Years to <18Years Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast Problems with Contrast Administration	0 participants	0 participants	0 participants	1 participants	—	—	—	—	—
Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast Investigator Decision	0 participants	4 participants	2 participants	1 participants	—	—	—	—	—
Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast Child Refused Procedure	0 participants	0 participants	2 participants	3 participants	—	—	—	—	—
Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast Parent Refused Procedure	0 participants	0 participants	5 participants	5 participants	—	—	—	—	—
Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast Difficulties with Anesthesia/Sedation	0 participants	0 participants	3 participants	3 participants	—	—	—	—	—
Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast Child Unable to Lie Still	0 participants	0 participants	1 participants	2 participants	—	—	—	—	—
Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast Missed Appointment	1 participants	0 participants	0 participants	0 participants	—	—	—	—	—
Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast Parent or Child Refused to Continue US	0 participants	2 participants	0 participants	0 participants	—	—	—	—	—
Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast Other reasons	0 participants	3 participants	8 participants	6 participants	—	—	—	—	—

PRIMARY outcome

Population: The imaged population included all enrolled participants who had at least one study-related diagnostic imaging procedure. n=number of adjudicated images

MRI with contrast (c) and without (w/o) contrast (c) enhancement were performed and a US was done within 48 hours of the MRI. Once detected, the DVT was adjudicated and confirmed by an independent central adjudication Committee (ICAC) consisting of experienced physicians not involved in the study and blinded to each participant's identity and clinical course. Participants were considered positive for DVT if at least one of the radiographic procedures was positive. Cohort A: Day 0=day of catheter placement; Day 40 (± 20 days)=day of imaging procedures at Visit 1, or if possible within 72 hours after a CVC is removed or lost. Cohort B Visit 1: within 7 days of initiation of symptoms of a CVC-related DVT (symptoms include but were not limited to: redness, pain/tenderness, swelling, presence of subcutaneous collaterals, catheter occlusion, and the presence of catheter related infection) or within 7 days of an incidental diagnosis of CVC-related DVT by radiographic imaging.

Outcome measures

Outcome measures
Measure	All Imaged Participants n=2 Participants All participants in Cohorts A, B, and C who had at least 1 radiographic procedure: Pediatric participants (full-term newborns to \<18 years) in which a CVC was to be placed or who had a CVC in place. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related deep vein thrombosis (DVT) or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).	Cohort A 2Years to <12Years n=30 Participants Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered 'state-of-the-art' or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.	Cohort A 12Years to <18Years n=45 Participants Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered 'state-of-the-art' or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.	Cohort B Newborn to <2Years n=1 Participants Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.	Cohort B 2Years to <12Years n=6 Participants Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.	Cohort B 12Years to <18Years n=7 Participants Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.	Cohort C Newborn to <2Years n=4 Participants Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.	Cohort C 2Years to <12Years n=28 Participants Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.	Cohort C 12Years to <18Years n=11 Participants Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
Number of Participants With an Adjudicated Deep Vein Thrombosis (DVT) Detected By a Study-Related Ultrasound (US) and/or MRI, By Cohort and Age Group DVTs (n=2,30,45,1,6,7,4,28,11)	1 participants	2 participants	4 participants	1 participants	2 participants	5 participants	0 participants	4 participants	3 participants
Number of Participants With an Adjudicated Deep Vein Thrombosis (DVT) Detected By a Study-Related Ultrasound (US) and/or MRI, By Cohort and Age Group Diagnosis by US(n=2,30,45,1,6,7,4,28,11)	1 participants	2 participants	4 participants	1 participants	2 participants	4 participants	0 participants	3 participants	2 participants
Number of Participants With an Adjudicated Deep Vein Thrombosis (DVT) Detected By a Study-Related Ultrasound (US) and/or MRI, By Cohort and Age Group Diagnosis by MRI w/o c (n=2,30,45,1,6,7,4,27,11)	0 participants	1 participants	2 participants	1 participants	1 participants	3 participants	0 participants	1 participants	1 participants
Number of Participants With an Adjudicated Deep Vein Thrombosis (DVT) Detected By a Study-Related Ultrasound (US) and/or MRI, By Cohort and Age Group Diagnosis by MRI with c (n=2,30,45,1,6,6,4,28,11)	0 participants	1 participants	2 participants	1 participants	1 participants	2 participants	0 participants	0 participants	2 participants

PRIMARY outcome

Population: n=participants with an adjudicated DVT identified by a study-related adjudicated radiographic procedure.

Adjudication was by an Independent Central Adjudication Committee (ICAC) consisting of experienced physicians not involved in the study and blinded to each participant's identity and clinical course. One set of 3 study-related diagnostic imaging procedures (US, MRI with contrast, and MRI without contrast) was performed. Participants were considered positive for DVT if at least one of the radiographic procedures was positive.

Outcome measures

Outcome measures
Measure	All Imaged Participants n=22 Participants All participants in Cohorts A, B, and C who had at least 1 radiographic procedure: Pediatric participants (full-term newborns to \<18 years) in which a CVC was to be placed or who had a CVC in place. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related deep vein thrombosis (DVT) or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).	Cohort A 2Years to <12Years Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered 'state-of-the-art' or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.	Cohort A 12Years to <18Years Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered 'state-of-the-art' or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.	Cohort B Newborn to <2Years Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.	Cohort B 2Years to <12Years Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.	Cohort B 12Years to <18Years Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.	Cohort C Newborn to <2Years Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.	Cohort C 2Years to <12Years Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.	Cohort C 12Years to <18Years Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
All Participants With an Adjudicated Deep Vein Thromboembolism (DVT) By Study-Related Radiographic Procedures That Diagnosed the DVT Ultrasound (n=22)	19 participants	—	—	—	—	—	—	—	—
All Participants With an Adjudicated Deep Vein Thromboembolism (DVT) By Study-Related Radiographic Procedures That Diagnosed the DVT MRI with Contrast (n=20)	9 participants	—	—	—	—	—	—	—	—
All Participants With an Adjudicated Deep Vein Thromboembolism (DVT) By Study-Related Radiographic Procedures That Diagnosed the DVT MRI without Contrast (n=21)	10 participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Population: All participants who had an adjudicated DVT identified by at lest one study-related radiographic procedure.

Adjudication was by an ICAC consisting of experienced physicians not involved in the study and blinded to each participant's identity and clinical course. One set of Study-related diagnostic imaging procedures (US, MRI with contrast, and MRI without contrast) was performed for all cohorts. Participants were considered positive for DVT if at least one of the radiographic procedures was positive.

Outcome measures

Outcome measures
Measure	All Imaged Participants n=22 Participants All participants in Cohorts A, B, and C who had at least 1 radiographic procedure: Pediatric participants (full-term newborns to \<18 years) in which a CVC was to be placed or who had a CVC in place. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related deep vein thrombosis (DVT) or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).	Cohort A 2Years to <12Years Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered 'state-of-the-art' or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.	Cohort A 12Years to <18Years Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered 'state-of-the-art' or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.	Cohort B Newborn to <2Years Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.	Cohort B 2Years to <12Years Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.	Cohort B 12Years to <18Years Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.	Cohort C Newborn to <2Years Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.	Cohort C 2Years to <12Years Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.	Cohort C 12Years to <18Years Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
Number of All Participants Identified With Adjudicated DVT Categorized By Presence or Absence of Symptoms at Enrollment Symptoms at Enrollment; Adjudicated DVT	8 Participants	—	—	—	—	—	—	—	—
Number of All Participants Identified With Adjudicated DVT Categorized By Presence or Absence of Symptoms at Enrollment Asymptomatic at Enrollment, Adjudicated DVT	14 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Enrollment up to Visit 1 plus 30 days (up to approximately 90 days)

Population: The imaged population included all enrolled participants who had at least one study-related diagnostic imaging procedure.

Signs and symptoms of PE include shortness of breath, pleuritic pain, cough, orthopnea, wheezing, and may have associated signs and symptoms of DVT. In the event a PE was detected while undergoing the study MRI or other imaging procedure required for care of an underlying condition, and the participant did not manifest any signs and/or symptoms of a PE, the event was considered an asymptomatic PE. The participant was managed and further investigated according to the investigator's standard of care. All diagnostic imaging procedures performed, such as contrast-enhanced computer tomography (CT) pulmonary angiogram, nuclear ventilation perfusion lung scan (V/Q scan), were submitted for adjudication as a suspected PE.

Outcome measures

Outcome measures
Measure	All Imaged Participants n=77 Participants All participants in Cohorts A, B, and C who had at least 1 radiographic procedure: Pediatric participants (full-term newborns to \<18 years) in which a CVC was to be placed or who had a CVC in place. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related deep vein thrombosis (DVT) or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).	Cohort A 2Years to <12Years n=14 Participants Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered 'state-of-the-art' or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.	Cohort A 12Years to <18Years n=43 Participants Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered 'state-of-the-art' or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.	Cohort B Newborn to <2Years Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.	Cohort B 2Years to <12Years Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.	Cohort B 12Years to <18Years Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.	Cohort C Newborn to <2Years Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.	Cohort C 2Years to <12Years Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.	Cohort C 12Years to <18Years Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
Number of Participants With Adjudicated Pulmonary Embolism (PE) Events (Symptomatic or Asymptomatic) Identified During the Study	0 participants	0 participants	0 participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Enrollment up to last US or MRI plus 30 days (up to approximately 90 days)

Population: The imaged population included all enrolled participants who had at least one study-related diagnostic imaging procedure.

Death as an endpoint in a participant with an adjudicated venous thromboembolism (DVT or PE) was summarized, regardless of the cause of the death. The VTE was adjudicated by a blinded central independent adjudication committee.

Outcome measures

Outcome measures
Measure	All Imaged Participants n=77 Participants All participants in Cohorts A, B, and C who had at least 1 radiographic procedure: Pediatric participants (full-term newborns to \<18 years) in which a CVC was to be placed or who had a CVC in place. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related deep vein thrombosis (DVT) or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).	Cohort A 2Years to <12Years n=14 Participants Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered 'state-of-the-art' or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.	Cohort A 12Years to <18Years n=43 Participants Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered 'state-of-the-art' or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.	Cohort B Newborn to <2Years Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.	Cohort B 2Years to <12Years Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.	Cohort B 12Years to <18Years Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.	Cohort C Newborn to <2Years Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.	Cohort C 2Years to <12Years Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.	Cohort C 12Years to <18Years Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
Number of Deaths Which Occurred During the Study Death related to study procedures	0 participants	0 participants	0 participants	—	—	—	—	—	—
Number of Deaths Which Occurred During the Study Death due to any cause	0 participants	1 participants	0 participants	—	—	—	—	—	—

Adverse Events

All Imaged Participants

Serious events: 25 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Imaged Participants n=134 participants at risk All participants in Cohorts A, B, and C who had at least 1 radiographic procedure: Pediatric participants (full-term newborns to \<18 years) in which a CVC was to be placed or who had a CVC in place. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related deep vein thrombosis (DVT) or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
General disorders Device deployment issue	0.75% 1/134 • Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C). Study initiated February 2011 and Last Patient, Last Visit was May 2013.
Injury, poisoning and procedural complications Subdural haematoma	0.75% 1/134 • Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C). Study initiated February 2011 and Last Patient, Last Visit was May 2013.
Vascular disorders Thrombosis	1.5% 2/134 • Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C). Study initiated February 2011 and Last Patient, Last Visit was May 2013.
Vascular disorders Deep vein thrombosis	0.75% 1/134 • Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C). Study initiated February 2011 and Last Patient, Last Visit was May 2013.
General disorders Medical device complication	0.75% 1/134 • Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C). Study initiated February 2011 and Last Patient, Last Visit was May 2013.
Renal and urinary disorders Renal impairment	0.75% 1/134 • Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C). Study initiated February 2011 and Last Patient, Last Visit was May 2013.
Cardiac disorders Ventricular tachycardia	0.75% 1/134 • Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C). Study initiated February 2011 and Last Patient, Last Visit was May 2013.
General disorders Extravasation	0.75% 1/134 • Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C). Study initiated February 2011 and Last Patient, Last Visit was May 2013.
Blood and lymphatic system disorders Anaemia	0.75% 1/134 • Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C). Study initiated February 2011 and Last Patient, Last Visit was May 2013.
Vascular disorders Jugular vein thrombosis	2.2% 3/134 • Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C). Study initiated February 2011 and Last Patient, Last Visit was May 2013.
Gastrointestinal disorders Pancreatitis acute	0.75% 1/134 • Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C). Study initiated February 2011 and Last Patient, Last Visit was May 2013.
Infections and infestations Skin infection	0.75% 1/134 • Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C). Study initiated February 2011 and Last Patient, Last Visit was May 2013.
General disorders Asthenia	0.75% 1/134 • Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C). Study initiated February 2011 and Last Patient, Last Visit was May 2013.
Infections and infestations Cellulitis	0.75% 1/134 • Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C). Study initiated February 2011 and Last Patient, Last Visit was May 2013.
Vascular disorders Embolism	0.75% 1/134 • Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C). Study initiated February 2011 and Last Patient, Last Visit was May 2013.
General disorders General physical health deterioration	0.75% 1/134 • Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C). Study initiated February 2011 and Last Patient, Last Visit was May 2013.
General disorders Mucosal inflammation	0.75% 1/134 • Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C). Study initiated February 2011 and Last Patient, Last Visit was May 2013.
Infections and infestations Pneumonia	1.5% 2/134 • Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C). Study initiated February 2011 and Last Patient, Last Visit was May 2013.
Infections and infestations Trichosporon infection	0.75% 1/134 • Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C). Study initiated February 2011 and Last Patient, Last Visit was May 2013.
Blood and lymphatic system disorders Febrile neutropenia	5.2% 7/134 • Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C). Study initiated February 2011 and Last Patient, Last Visit was May 2013.
General disorders Thrombosis in device	2.2% 3/134 • Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C). Study initiated February 2011 and Last Patient, Last Visit was May 2013.
Vascular disorders Venous occlusion	0.75% 1/134 • Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C). Study initiated February 2011 and Last Patient, Last Visit was May 2013.
Investigations Platelet count decreased	0.75% 1/134 • Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C). Study initiated February 2011 and Last Patient, Last Visit was May 2013.
Gastrointestinal disorders Proctalgia	0.75% 1/134 • Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C). Study initiated February 2011 and Last Patient, Last Visit was May 2013.
General disorders Pyrexia	2.2% 3/134 • Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C). Study initiated February 2011 and Last Patient, Last Visit was May 2013.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.75% 1/134 • Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C). Study initiated February 2011 and Last Patient, Last Visit was May 2013.

Other adverse events

Other adverse events
Measure	All Imaged Participants n=134 participants at risk All participants in Cohorts A, B, and C who had at least 1 radiographic procedure: Pediatric participants (full-term newborns to \<18 years) in which a CVC was to be placed or who had a CVC in place. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related deep vein thrombosis (DVT) or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
Gastrointestinal disorders Nausea	5.2% 7/134 • Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C). Study initiated February 2011 and Last Patient, Last Visit was May 2013.
Gastrointestinal disorders Vomiting	8.2% 11/134 • Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C). Study initiated February 2011 and Last Patient, Last Visit was May 2013.

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Publication restrictions are in place

Restriction type: OTHER