A Phase 1 interventional study of Gadobutrol (Gadavist, BAY86-4875) in Magnetic Resonance Imaging, sponsored by Bayer. Completed at 9 sites in 3 countries. Open to participants aged Up to 2 Years. Per ClinicalTrials.gov, last updated 2020-12-16.
Sponsored by Bayer · Phase 1, Interventional, and Diagnostic
The main purpose of this study is to collect data on the way gadobutrol is taken into, moves around, and is eliminated from, the body of children aged 0 to less than 2 years. The study will also evaluate safety and tolerability, and efficacy of gadobutrol.
A maximum total amount of approximately 5 ml of blood will be needed for these analyses which will be drawn within 2-3 days.
Gadobutrol is a contrast agent used for enhancement of Magnetic Resonance Imaging (MRI), potentially allowing better visibility of tissues in the body. Children aged under 2 years scheduled for a routine contrast-enhanced MRI examination of any body region may take part in this study, in which case they will receive gadobutrol as contrast agent intravenously at the standard dose of 0.1 mmol/kg (0.1 ml/Kg) of body weight. Only subjects without renal insufficiency of any intensity (i.e. estimated Glomerular Filtration Rate \<80% of age adjusted normal value calculated based on the Schwartz formula) will be included in the trial.
The duration of this study as a whole is around 1 year and the total number of children to be enrolled is 50. A child will be expected to take part in the study for around 7 days.
Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Gadobutrol (Gadavist, BAY86-4875)
Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants \<2 years of age.
Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Infinity of Gadobutrol: Individual
AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC from time 0 (start of injection) to infinity was reported in micromole\*hour per liter (micromole\*h/L).
Time frame: Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol
Body Weight-Normalized Total Body Clearance (CL) of Gadobutrol From Plasma: Individual
Clearance is the volume of the fluid presented to the eliminating organ that is effectively completely cleared of drug per unit time and depends on the rate of elimination. CL of gadobutrol normalized for body weight, was reported in Liter per hour per kilogram (L/(h\*kg).
Time frame: Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol
Body Weight-Normalized Apparent Volume of Distribution at Steady State (Vss) of Gadobutrol in Plasma: Individual
Vss is an estimate of drug distribution independent of the elimination process and is proportional to the amount of drug in the body versus the drug plasma concentration at steady-state.
Time frame: Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol
Mean Residence Time (MRT) of Gadobutrol in Plasma: Individual
MRT is the average time that the molecules introduced into the body stay in the body. MRT of Gadobutrol is expressed in hours.
Time frame: Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol
Terminal Elimination Half-Life (t1/2) of Gadobutrol From Plasma: Individual
Half-life refers to the elimination of the drug, that is, the time it takes for the blood plasma concentration to reach half the concentration. Terminal elimination half-life of gadobutrol from plasma is expressed in hours and is derived from the terminal slope of the concentration versus time curve.
Time frame: Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol
Simulation of Plasma Concentration of Gadobutrol at 20 Minutes Post-Injection (C20)
Simulation is the use of the model to predict data other than observed data, in this case early Gadobutrol plasma concentration after intravenous injection. Plasma concentration serves as a surrogate for efficacy (signal and contrast enhancement) in MRI. C20 was simulated for virtual pediatric subjects with homogenous distribution over age. Simulated median (5th and 95th percentile in parenthesis) gadolinium plasma concentrations for a dose of 0.1 mmol/kg body weight were presented.
Time frame: 20 minutes post-injection
Simulation of Plasma Concentration of Gadobutrol at 30 Minutes Post-Injection (C30)
Simulation is the use of the model to predict data other than observed data, in this case early Gadobutrol plasma concentration after intravenous injection. Plasma concentration serves as a surrogate for efficacy (signal and contrast enhancement) in MRI. C30 was simulated for virtual pediatric subjects with homogenous distribution over age. Simulated median (5th and 95th percentile in parenthesis) gadolinium plasma concentrations for a dose of 0.1 mmol/kg body weight were presented.
Time frame: 30 minutes post-injection
Number of Subjects With Anatomical Area Evaluated
Subjects were referred for MRI of any body region. The primary anatomical area to be evaluated by MRI was assessed. Anatomical Area was recorded prior to gadobutrol injection for the unenhanced MRI procedure and after gadobutrol injection for the gadobutrol-enhanced MRI procedure. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Technical Adequacy for Diagnosis
The technical adequacy of the unenhanced image set and the combined unenhanced and enhanced image set was assessed based on the following 4 point scale: 1=Region visualized with artifacts compromising quality and interpretability of images, 2=Only partial evaluation of images possible, region not covered adequately anatomically, 3=Region visualized with artifacts, partially compromising image quality but evaluation and diagnosis still possible, 4=Region clearly visualized, excellent quality. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Technical Adequacy for Diagnosis by Body Region
The technical adequacy of the the unenhanced image set and the combined unenhanced and enhanced image set was assessed based 4-point scale and body region. Four-point scale: 1=Region visualized with artifacts compromising quality and interpretability of images, 2=Only partial evaluation of images possible, region not covered adequately anatomically, 3=Region visualized with artifacts, partially compromising image quality but evaluation and diagnosis still possible, 4=Region clearly visualized, excellent quality. Evaluation was done on pre-injection and combined images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects by Overall Contrast Quality
A qualitative assessment of the overall contrast using the following pre-defined 5-point scale: 1= None (for example, in case of a non-enhancing vessel), 2= Poor, 3= Moderate, 4= Good, 5= Excellent, was done. This parameter was assessed in the postcontrast MRI only, which is evaluated together with the unenhanced, this is why it is called combined. Data for combined MRI set was reported.
Time frame: Images were taken post-injection (within about 15 minutes)
Number of Subjects by Overall Contrast Quality by Body Region
A qualitative assessment of the overall contrast using the following pre-defined 5-point scale: 1= None (for example, in case of a non-enhancing vessel), 2= Poor, 3= Moderate, 4= Good, 5= Excellent, was done in the postcontrast MRI only, which is evaluated together with the unenhanced, this is why it is called combined. Data for combined MRI set was reported.
Time frame: Images were taken post-injection (within about 15 minutes)
Number of Subjects With Presence of Pathology
Presence of pathology was assessed for unenhanced and combined MRI sets and recorded as "yes/no". The number of lesions identified for each MRI set was recorded.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Presence of Pathology by Body Region
Presence of pathology was assessed for unenhanced and combined MRI sets and recorded as "yes/no". The number of lesions identified for each MRI set was recorded. Results per body region were reported.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Number of Lesions Detected
Presence of pathology included presence of lesions and was recorded as "yes/no". If "yes" the number of subjects with specified lists of lesions and body region was reported. Evaluation was done on pre- injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Number of Lesions Detected by Body Region
Presence of pathology included presence of lesions and was recorded as "yes/no". If "yes" the number of subjects with specified lists of lesions and body region was reported. Evaluation was done on pre- injection and combined (pre- and post-injection) images. Data of subjects with missing number of lesions or at least one lesion in unenhanced and combined MRI sets were reported.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Contrast Enhancement in Lesion or Vessel
The contrast-enhancement for each lesion or vessel was recorded on a 4-point scale: 1 = None, lesion or vessel is not enhanced; 2 = Moderate, lesion or vessel is weakly enhanced; 3 = Good, lesion or vessel is clearly enhanced; 4 = Excellent, lesion or vessel is clearly and brightly enhanced. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Contrast Enhancement in Lesion or Vessel by Body Region
The contrast-enhancement for each lesion or vessel was recorded on a 4-point scale: 1 = None, lesion or vessel is not enhanced; 2 = Moderate, lesion or vessel is weakly enhanced; 3 = Good, lesion or vessel is clearly enhanced; 4 = Excellent, lesion or vessel is clearly and brightly enhanced. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Border Delineation of Lesion of Vessel
The border delineation for each lesion or vessel was recorded on a 4-point scale: 1 = None, no or unclear delineation of the boundary between the lesion or vessel and the surrounding tissue; 2 = Moderate, some aspects of border delineation covered; 3 = Good, almost clear delineation, but not complete on relevant slices; 4 = Excellent, clear and complete delineation.Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Border Delineation of Lesion of Vessel by Body Region
The border delineation for each lesion or vessel was recorded on a 4-point scale: 1 = None, no or unclear delineation of the boundary between the lesion or vessel and the surrounding tissue; 2 = Moderate, some aspects of border delineation covered; 3 = Good, almost clear delineation, but not complete on relevant slices; 4 = Excellent, clear and complete delineation.The results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement
The degree of visualization of internal morphology and structure was recorded on a 3-point scale: 1= Poor, the structure and internal morphology of the lesion or vessel is poorly visible; 2 = Moderate, the structure and internal morphology of the lesion or vessel is visible but sufficient information cannot be obtained; 3 = Good, the structure and internal morphology of the lesion or vessel is sufficiently visible for diagnostic purposes.Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region
The degree of visualization of internal morphology and structure was recorded on a 3-point scale: 1 = Poor, the structure and internal morphology of the lesion or vessel is poorly visible; 2 = Moderate, the structure and internal morphology of the lesion or vessel is visible but sufficient information cannot be obtained; 3 = Good, the structure and internal morphology of the lesion or vessel is sufficiently visible for diagnostic purposes. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Diagnoses
The following diagnoses were reported for both the unenhanced MRI and the combined MRI image sets: Other diagnoses, No lesions/normal, Congenital disease/syndrome, Malignant lesion, Inflammation, Structural malformation, Benign lesion, and Vascular malformation. Evaluation was done on pre- injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Diagnoses by Body Region
The following diagnoses were reported for both the unenhanced MRI and the combined MRI image sets: Other diagnoses, No lesions/normal, Congenital disease/syndrome, Malignant lesion, Inflammation, Structural malformation, Benign lesion, and Vascular malformation. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Additional Diagnostic Gain
Additional diagnostic gain by the contrast-enhanced image set was assessed on a 3-point scale: scale 1 = Initial diagnosis unchanged, scale 2 = Initial diagnosis changed - improved, i.e. more specific, and scale 3 = Initial diagnosis changed -new diagnosis. Evaluation was done on combined (pre- and post- injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Additional Diagnostic Gain by Body Region
Additional diagnostic gain by the contrast-enhanced image set was assessed on a 3-point scale: scale 1 = Initial diagnosis unchanged, scale 2 = Initial diagnosis changed - improved, i.e. more specific, and scale 3 = Initial diagnosis changed -new diagnosis. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Confidence in Diagnosis
Diagnostic confidence based on the unenhanced MRI image sets and thereafter on the combined MRI image sets were assessed on a 3-point scale, as 1 = Not confident, 2 = Confident and 3 = Very confident. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Confidence in Diagnosis by Body Region
Diagnostic confidence based on the unenhanced MRI image sets and thereafter on the combined MRI image sets were assessed on a 3-point scale, as 3 = Very confident, 2 = Confident, and 1 = Not confident. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Final Diagnosis
The final diagnosis of the subjects was based on all clinical information available and was provided separately within 4 weeks after MRI. Evaluation was done on pre-injection and combined (pre- and post- injection) images.
Time frame: Up to 4 weeks post-injection
Number of Subjects With Final Diagnosis by Body Region
The final diagnosis of the subjects was based on all clinical information available and was provided separately within 4 weeks after MRI. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images. Only subjects with final diagnosis were reported.
Time frame: Up to 4 weeks post-injection
Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI
The analysis value for change in diagnosis was recorded as "yes/no". Evaluation was done on pre- injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI by Body Region
The analysis value for change in diagnosis was recorded as "yes/no". Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis
The analysis value for change in diagnosis was recorded as "yes/no". Evaluation was done on pre- injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis by Body Region
The analysis value for change in diagnosis was recorded as "yes/no". Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis
The analysis value for change in diagnosis was recorded as "yes/no". Evaluation was done on pre- injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis by Body Region
The analysis value for change in diagnosis was recorded as "yes/no". Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Change in Management From Unenhanced to Combined MRI
The subject management was indicated based on the unenhanced images alone. The analysis value for change in subject management was recorded as "yes/no". Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Change in Management From Unenhanced to Combined MRI by Body Region
The subject management was indicated based on the unenhanced images alone. The analysis value for change in subject management was recorded as "yes/no". Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Clinically Significant Abnormal Laboratory Values
Change in post-injection test values, such as resulting in a change in subject management or which were not the result of laboratory error and were considered clinically significant by the investigator was reported.
Time frame: Baseline (not exceeding 24 hours before Gadobutrol injection) up to 24 hours post injection
Estimated Glomerular Filtration Rate (eGFR) Prior to Gadobutrol Injection
eGFR was calculated based on the Schwartz formula with blood sampling for serum creatinine (Scr) not exceeding 14 days prior to gadobutrol injection. Otherwise, the eGFR was obtained from the original Schwartz formula: eGFR = k \* height / Scr where k = 0.45 in term newborn infants \< 1 year of age, and k = 0.55 in children up to 13 years of age. If Scr was measured by an enzymatic creatinine method that had been calibrated to be traceable to Isotope dilution mass spectroscopy (IDMS), the updated Schwartz formula was used: eGFR = 0.413\*height/Scr.
Time frame: Before gadobutrol injection
Number of Subjects With Drug Related Serious and Non- Serious Adverse Events
An Adverse Event (AE) was any untoward medical occurrence in a subject who received study drug. A Serious AE (SAE) was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly, or deemed significant for any other reason. The drug-relatedness of AEs was determined by the Investigator based on his/her clinical decision based on all available information, and was based on the question whether there was a "reasonable causal relationship" to the study treatment.
Time frame: From baseline to approximately 7 days after injection
Pediatric subjects who were less than (\<) 2 years of age, scheduled to undergo contrast-enhanced magnetic resonance imaging (MRI) for routine diagnostic purposes were included in the study and were recruited from 9 centres in Canada, Germany and United States of America.
| Milestone | Overall Study |
|---|---|
| Started | 44 |
| Completed | 44 |
| Not completed | 0 |
AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC from time 0 (start of injection) to infinity was reported in micromole\*hour per liter (micromole\*h/L).
| micromole*h/L | Overall Study |
|---|---|
| Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Infinity of Gadobutrol: Individual | 776 (544 to 1470) |
Clearance is the volume of the fluid presented to the eliminating organ that is effectively completely cleared of drug per unit time and depends on the rate of elimination. CL of gadobutrol normalized for body weight, was reported in Liter per hour per kilogram (L/(h\*kg).
| L/(h*kg) | Overall Study |
|---|---|
| Body Weight-Normalized Total Body Clearance (CL) of Gadobutrol From Plasma: Individual | 0.128 (0.0666 to 0.184) |
Vss is an estimate of drug distribution independent of the elimination process and is proportional to the amount of drug in the body versus the drug plasma concentration at steady-state.
| L/kg | Overall Study |
|---|---|
| Body Weight-Normalized Apparent Volume of Distribution at Steady State (Vss) of Gadobutrol in Plasma: Individual | 0.277 (0.236 to 0.409) |
MRT is the average time that the molecules introduced into the body stay in the body. MRT of Gadobutrol is expressed in hours.
| hours | Overall Study |
|---|---|
| Mean Residence Time (MRT) of Gadobutrol in Plasma: Individual | 2.18 (1.57 to 4.68) |
Half-life refers to the elimination of the drug, that is, the time it takes for the blood plasma concentration to reach half the concentration. Terminal elimination half-life of gadobutrol from plasma is expressed in hours and is derived from the terminal slope of the concentration versus time curve.
| hours | Overall Study |
|---|---|
| Terminal Elimination Half-Life (t1/2) of Gadobutrol From Plasma: Individual | 1.62 (1.16 to 3.37) |
Simulation is the use of the model to predict data other than observed data, in this case early Gadobutrol plasma concentration after intravenous injection. Plasma concentration serves as a surrogate for efficacy (signal and contrast enhancement) in MRI. C20 was simulated for virtual pediatric subjects with homogenous distribution over age. Simulated median (5th and 95th percentile in parenthesis) gadolinium plasma concentrations for a dose of 0.1 mmol/kg body weight were presented.
| micromole/L | Overall Study |
|---|---|
| Simulation of Plasma Concentration of Gadobutrol at 20 Minutes Post-Injection (C20) | 339 (230 to 456) |
Simulation is the use of the model to predict data other than observed data, in this case early Gadobutrol plasma concentration after intravenous injection. Plasma concentration serves as a surrogate for efficacy (signal and contrast enhancement) in MRI. C30 was simulated for virtual pediatric subjects with homogenous distribution over age. Simulated median (5th and 95th percentile in parenthesis) gadolinium plasma concentrations for a dose of 0.1 mmol/kg body weight were presented.
| micromole/L | Overall Study |
|---|---|
| Simulation of Plasma Concentration of Gadobutrol at 30 Minutes Post-Injection (C30) | 292 (194 to 394) |
Subjects were referred for MRI of any body region. The primary anatomical area to be evaluated by MRI was assessed. Anatomical Area was recorded prior to gadobutrol injection for the unenhanced MRI procedure and after gadobutrol injection for the gadobutrol-enhanced MRI procedure. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
| subjects | Unenhanced MRI Assessment | Combined MRI Assessment |
|---|---|---|
| Abdomen: Liver | 1 | 1 |
| Brain: Brain | 20 | 20 |
| Brain: Orbit and brain | 1 | 1 |
| Chest/thorax: Lung | 2 | 2 |
| Head/neck: Head | 3 | 3 |
| Head/neck: Neck | 1 | 1 |
| Head/neck: Skull base/mandible | 1 | 1 |
| Lymphatic system: Right arm | 1 | 1 |
| Pelvic area:Trochanter major, femur neck | 1 | 1 |
| Pelvic area: Testis | 1 | 1 |
| Retroperitoneal: Kidney | 6 | 6 |
| Retroperitoneal: Adrenal gland | 1 | 1 |
| Spine: Spinal cord | 4 | 4 |
| Spine: Lumbar spine | 1 | 1 |
The technical adequacy of the unenhanced image set and the combined unenhanced and enhanced image set was assessed based on the following 4 point scale: 1=Region visualized with artifacts compromising quality and interpretability of images, 2=Only partial evaluation of images possible, region not covered adequately anatomically, 3=Region visualized with artifacts, partially compromising image quality but evaluation and diagnosis still possible, 4=Region clearly visualized, excellent quality. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
| subjects | Unenhanced MRI Assessment | Combined MRI Assessment |
|---|---|---|
| Score = 1 | 0 | 0 |
| Score = 2 | 0 | 0 |
| Score = 3 | 4 | 3 |
| Score = 4 | 40 | 41 |
The technical adequacy of the the unenhanced image set and the combined unenhanced and enhanced image set was assessed based 4-point scale and body region. Four-point scale: 1=Region visualized with artifacts compromising quality and interpretability of images, 2=Only partial evaluation of images possible, region not covered adequately anatomically, 3=Region visualized with artifacts, partially compromising image quality but evaluation and diagnosis still possible, 4=Region clearly visualized, excellent quality. Evaluation was done on pre-injection and combined images.
| subjects | Unenhanced MRI Assessment | Combined MRI Assessment |
|---|---|---|
| Abdomen: Score 4 | 1 | 1 |
| Brain: Score 3 | 1 | 1 |
| Brain: Score 4 | 20 | 20 |
| Chest/thorax: Score 4 | 2 | 2 |
| Head/neck: Score 3 | 1 | 1 |
| Head/neck: Score 4 | 4 | 4 |
| Lymphatic system: Score 4 | 1 | 1 |
| Pelvic area: Score 4 | 2 | 2 |
| Retroperitoneal area: Score 4 | 7 | 7 |
| Spine: Score 3 | 2 | 1 |
| Spine: Score 4 | 3 | 4 |
A qualitative assessment of the overall contrast using the following pre-defined 5-point scale: 1= None (for example, in case of a non-enhancing vessel), 2= Poor, 3= Moderate, 4= Good, 5= Excellent, was done. This parameter was assessed in the postcontrast MRI only, which is evaluated together with the unenhanced, this is why it is called combined. Data for combined MRI set was reported.
| subjects | Combined MRI Assessment |
|---|---|
| None | 1 |
| Poor | 0 |
| Moderate | 0 |
| Good | 5 |
| Excellent | 38 |
A qualitative assessment of the overall contrast using the following pre-defined 5-point scale: 1= None (for example, in case of a non-enhancing vessel), 2= Poor, 3= Moderate, 4= Good, 5= Excellent, was done in the postcontrast MRI only, which is evaluated together with the unenhanced, this is why it is called combined. Data for combined MRI set was reported.
| subjects | Combined MRI Assessment |
|---|---|
| Abdomen: Excellent | 1 |
| Brain: Good | 2 |
| Brain: Excellent | 19 |
| Chest/Thorax: Good | 1 |
| Chest/Thorax: Excellent | 1 |
| Head/Neck: Excellent | 5 |
| Lymphatic system: Excellent | 1 |
| Pelvic area: Excellent | 2 |
| Retroperitoneal: None | 1 |
| Retroperitoneal: Good | 1 |
| Retroperitoneal: Excellent | 5 |
| Spine: Good | 1 |
| Spine: Excellent | 4 |
Presence of pathology was assessed for unenhanced and combined MRI sets and recorded as "yes/no". The number of lesions identified for each MRI set was recorded.
| subjects | Unenhanced MRI Assessment | Combined MRI Assessment |
|---|---|---|
| Yes | 33 | 33 |
| No | 11 | 11 |
Presence of pathology was assessed for unenhanced and combined MRI sets and recorded as "yes/no". The number of lesions identified for each MRI set was recorded. Results per body region were reported.
| subjects | Unenhanced MRI Assessment | Combined MRI Assessment |
|---|---|---|
| Abdomen: No | 0 | 0 |
| Abdomen: Yes | 1 | 1 |
| Brain: No | 10 | 10 |
| Brain: Yes | 11 | 11 |
| Chest/Thorax: No | 0 | 0 |
| Chest/Thorax: Yes | 2 | 2 |
| Head/Neck: No | 0 | 0 |
| Head/Neck: Yes | 5 | 5 |
| Lymphatic system: No | 0 | 0 |
| Lymphatic system: Yes | 1 | 1 |
| Pelvic area: No | 0 | 0 |
| Pelvic area: Yes | 2 | 2 |
| Retroperitoneal: No | 0 | 0 |
| Retroperitoneal: Yes | 7 | 7 |
| Spine: No | 1 | 1 |
| Spine: Yes | 4 | 4 |
Presence of pathology included presence of lesions and was recorded as "yes/no". If "yes" the number of subjects with specified lists of lesions and body region was reported. Evaluation was done on pre- injection and combined (pre- and post-injection) images.
| subjects | Unenhanced MRI Assessment | Combined MRI Assessment |
|---|---|---|
| Number of lesions=missing | 2 | 1 |
| Number of lesions=1 | 29 | 29 |
| Number of lesions=2 | 2 | 2 |
| Number of lesions=10 | 0 | 1 |
Presence of pathology included presence of lesions and was recorded as "yes/no". If "yes" the number of subjects with specified lists of lesions and body region was reported. Evaluation was done on pre- injection and combined (pre- and post-injection) images. Data of subjects with missing number of lesions or at least one lesion in unenhanced and combined MRI sets were reported.
| subjects | Unenhanced MRI Assessment | Combined MRI Assessment |
|---|---|---|
| Abdomen: Missing lesion | 1 | 1 |
| Brain: 1 lesion | 10 | 10 |
| Brain: 2 lesion | 1 | 1 |
| Chest/Thorax: 1 lesion | 2 | 2 |
| Head/Neck: Missing lesion | 1 | 0 |
| Head/Neck: 1 lesion | 4 | 4 |
| Head/Neck: 10 lesion | 0 | 1 |
| Lymphatic system: 1 lesion | 1 | 1 |
| Pelvic area: 1 lesion | 2 | 2 |
| Retroperitoneal: 1 lesion | 6 | 6 |
| Retroperitoneal: 2 lesion | 1 | 1 |
| Spine: 1 lesion | 4 | 4 |
The contrast-enhancement for each lesion or vessel was recorded on a 4-point scale: 1 = None, lesion or vessel is not enhanced; 2 = Moderate, lesion or vessel is weakly enhanced; 3 = Good, lesion or vessel is clearly enhanced; 4 = Excellent, lesion or vessel is clearly and brightly enhanced. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
| subjects | Unenhanced MRI Assessment | Combined MRI Assessment |
|---|---|---|
| None | 44 | 3 |
| Moderate | 0 | 0 |
| Good | 0 | 6 |
| Excellent | 0 | 35 |
The contrast-enhancement for each lesion or vessel was recorded on a 4-point scale: 1 = None, lesion or vessel is not enhanced; 2 = Moderate, lesion or vessel is weakly enhanced; 3 = Good, lesion or vessel is clearly enhanced; 4 = Excellent, lesion or vessel is clearly and brightly enhanced. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
| subjects | Unenhanced MRI Assessment | Combined MRI Assessment |
|---|---|---|
| Abdomen: None | 1 | 1 |
| Blood vessel: None | 2 | 0 |
| Blood vessel: Excellent | 0 | 2 |
| Brain: None | 19 | 0 |
| Brain: Good | 0 | 1 |
| Brain: Excellent | 0 | 18 |
| Chest/Thorax: None | 2 | 1 |
| Chest/Thorax: Good | 0 | 1 |
| Head/Neck: None | 5 | 0 |
| Head/Neck: Good | 0 | 1 |
| Head/Neck: Excellent | 0 | 4 |
| Lymphatic system: None | 1 | 0 |
| Lymphatic system: Excellent | 0 | 1 |
| Pelvic area: None | 2 | 0 |
| Pelvic area: Good | 0 | 2 |
| Retroperitoneal: None | 7 | 1 |
| Retroperitoneal: Excellent | 0 | 6 |
| Spine: None | 5 | 0 |
| Spine: Good | 0 | 1 |
| Spine: Excellent | 0 | 4 |
The border delineation for each lesion or vessel was recorded on a 4-point scale: 1 = None, no or unclear delineation of the boundary between the lesion or vessel and the surrounding tissue; 2 = Moderate, some aspects of border delineation covered; 3 = Good, almost clear delineation, but not complete on relevant slices; 4 = Excellent, clear and complete delineation.Evaluation was done on pre-injection and combined (pre- and post-injection) images.
| subjects | Unenhanced MRI Assessment | Combined MRI Assessment |
|---|---|---|
| None | 5 | 1 |
| Moderate | 6 | 0 |
| Good | 9 | 1 |
| Excellent | 24 | 42 |
The border delineation for each lesion or vessel was recorded on a 4-point scale: 1 = None, no or unclear delineation of the boundary between the lesion or vessel and the surrounding tissue; 2 = Moderate, some aspects of border delineation covered; 3 = Good, almost clear delineation, but not complete on relevant slices; 4 = Excellent, clear and complete delineation.The results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
| subjects | Unenhanced MRI Assessment | Combined MRI Assessment |
|---|---|---|
| Abdomen: Excellent | 1 | 1 |
| Blood vessel: Excellent | 2 | 2 |
| Brain: Moderate | 3 | 0 |
| Brain: Good | 6 | 0 |
| Brain: Excellent | 10 | 19 |
| Chest/Thorax: Good | 1 | 0 |
| Chest/Thorax: Excellent | 1 | 2 |
| Lymphatic system: Excellent | 1 | 1 |
| Pelvic area: Moderate | 1 | 0 |
| Pelvic area: Excellent | 1 | 2 |
| Retroperitoneal: None | 3 | 1 |
| Retroperitoneal: Excellent | 4 | 6 |
| Spine: None | 2 | 0 |
| Spine: Moderate | 2 | 0 |
| Spine: Excellent | 1 | 5 |
| Head/Neck: Good | 2 | 1 |
| Head/Neck: Excellent | 3 | 4 |
The degree of visualization of internal morphology and structure was recorded on a 3-point scale: 1= Poor, the structure and internal morphology of the lesion or vessel is poorly visible; 2 = Moderate, the structure and internal morphology of the lesion or vessel is visible but sufficient information cannot be obtained; 3 = Good, the structure and internal morphology of the lesion or vessel is sufficiently visible for diagnostic purposes.Evaluation was done on pre-injection and combined (pre- and post-injection) images.
| subjects | Unenhanced MRI Assessment | Combined MRI Assessment |
|---|---|---|
| Poor | 6 | 1 |
| Moderate | 11 | 0 |
| Good | 27 | 43 |
The degree of visualization of internal morphology and structure was recorded on a 3-point scale: 1 = Poor, the structure and internal morphology of the lesion or vessel is poorly visible; 2 = Moderate, the structure and internal morphology of the lesion or vessel is visible but sufficient information cannot be obtained; 3 = Good, the structure and internal morphology of the lesion or vessel is sufficiently visible for diagnostic purposes. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
| subjects | Unenhanced MRI Assessment | Combined MRI Assessment |
|---|---|---|
| Abdomen: Good | 1 | 1 |
| Blood vessel: Good | 2 | 2 |
| Brain: Poor | 1 | 0 |
| Brain: Moderate | 5 | 0 |
| Brain: Good | 13 | 19 |
| Chest/Thorax: Moderate | 1 | 0 |
| Chest/Thorax: Good | 1 | 2 |
| Head/Neck: Poor | 1 | 0 |
| Head/Neck: Good | 4 | 5 |
| Lymphatic system: Good | 1 | 1 |
| Pelvic area: Moderate | 2 | 0 |
| Pelvic area: Good | 0 | 2 |
| Retroperitoneal: Poor | 3 | 1 |
| Retroperitoneal: Good | 4 | 6 |
| Spine: Poor | 1 | 0 |
| Spine: Moderate | 3 | 0 |
| Spine: Good | 1 | 5 |
The following diagnoses were reported for both the unenhanced MRI and the combined MRI image sets: Other diagnoses, No lesions/normal, Congenital disease/syndrome, Malignant lesion, Inflammation, Structural malformation, Benign lesion, and Vascular malformation. Evaluation was done on pre- injection and combined (pre- and post-injection) images.
| subjects | Unenhanced MRI Assessment | Combined MRI Assessment |
|---|---|---|
| Benign lesion | 1 | 2 |
| Malignant lesion | 4 | 4 |
| Vascular malformation | 1 | 1 |
| Structural malformation | 2 | 2 |
| Inflammation | 2 | 3 |
| Congenital disease / syndrome | 6 | 8 |
| No lesion/Normal | 10 | 11 |
| Other | 18 | 13 |
The following diagnoses were reported for both the unenhanced MRI and the combined MRI image sets: Other diagnoses, No lesions/normal, Congenital disease/syndrome, Malignant lesion, Inflammation, Structural malformation, Benign lesion, and Vascular malformation. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
| subjects | Unenhanced MRI Assessment | Combined MRI Assessment |
|---|---|---|
| Abdomen: Other | 1 | 1 |
| Brain: Malignant lesion | 1 | 1 |
| Brain: Inflammation | 1 | 1 |
| Brain: Congenital disease/syndrome | 3 | 3 |
| Brain: No lesion/Normal | 9 | 10 |
| Brain: Other | 7 | 6 |
| Chest/Thorax: Structural malformation | 1 | 1 |
| Chest/Thorax: Other | 1 | 1 |
| Head/Neck: Benign lesion | 1 | 1 |
| Head/Neck: Malignant lesion | 1 | 1 |
| Head/Neck: Inflammation | 1 | 1 |
| Head/Neck: Other | 2 | 2 |
| Lymphatic system: Vascular malformation | 1 | 1 |
| Pelvic area: Benign lesion | 0 | 1 |
| Pelvic area: Inflammation | 0 | 1 |
| Pelvic area: Other | 2 | 0 |
| Retroperitoneal: Malignant lesion | 1 | 1 |
| Retroperitoneal: Congenital disease/syndrome | 3 | 5 |
| Retroperitoneal: Other | 3 | 1 |
| Spine: Malignant lesion | 1 | 1 |
| Spine: Structural malformation | 1 | 1 |
| Spine: No lesion/Normal | 1 | 1 |
| Spine: Other | 2 | 2 |
Additional diagnostic gain by the contrast-enhanced image set was assessed on a 3-point scale: scale 1 = Initial diagnosis unchanged, scale 2 = Initial diagnosis changed - improved, i.e. more specific, and scale 3 = Initial diagnosis changed -new diagnosis. Evaluation was done on combined (pre- and post- injection) images.
| subjects | Combined MRI Assessment |
|---|---|
| Scale 1 | 19 |
| Scale 2 | 24 |
| Scale 3 | 1 |
Additional diagnostic gain by the contrast-enhanced image set was assessed on a 3-point scale: scale 1 = Initial diagnosis unchanged, scale 2 = Initial diagnosis changed - improved, i.e. more specific, and scale 3 = Initial diagnosis changed -new diagnosis. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
| subjects | Combined MRI Assessment |
|---|---|
| Abdomen: Scale 2 | 1 |
| Brain: Scale 1 | 11 |
| Brain: Scale 2 | 9 |
| Brain: Scale 3 | 1 |
| Chest/Thorax: Scale 2 | 2 |
| Head/Neck: Scale 1 | 3 |
| Head/Neck: Scale 2 | 2 |
| Lymphatic system: Scale 2 | 1 |
| Pelvic area: Scale 2 | 2 |
| Retroperitoneal: Scale 1 | 3 |
| Retroperitoneal: Scale 2 | 4 |
| Spine: Scale 1 | 2 |
| Spine: Scale 2 | 3 |
Diagnostic confidence based on the unenhanced MRI image sets and thereafter on the combined MRI image sets were assessed on a 3-point scale, as 1 = Not confident, 2 = Confident and 3 = Very confident. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
| subjects | Unenhanced MRI Assessment | Combined MRI Assessment |
|---|---|---|
| Not confident | 6 | 1 |
| Confident | 14 | 3 |
| Very confident | 24 | 40 |
Diagnostic confidence based on the unenhanced MRI image sets and thereafter on the combined MRI image sets were assessed on a 3-point scale, as 3 = Very confident, 2 = Confident, and 1 = Not confident. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
| subjects | Unenhanced MRI Assessment | Combined MRI Assessment |
|---|---|---|
| Abdomen: Confident | 1 | 1 |
| Brain: Not confident | 1 | 0 |
| Brain: Confident | 8 | 0 |
| Brain: Very confident | 12 | 21 |
| Chest/Thorax: Confident | 1 | 0 |
| Chest/Thorax: Very confident | 1 | 2 |
| Head/Neck: Confident | 2 | 0 |
| Head/Neck: Very confident | 3 | 5 |
| Lymphatic system: Very confident | 1 | 1 |
| Pelvic area: Not confident | 2 | 0 |
| Pelvic area: Confident | 0 | 2 |
| Retroperitoneal: Not confident | 3 | 1 |
| Retroperitoneal: Very confident | 4 | 6 |
| Spine: Confident | 2 | 0 |
| Spine: Very confident | 3 | 5 |
The final diagnosis of the subjects was based on all clinical information available and was provided separately within 4 weeks after MRI. Evaluation was done on pre-injection and combined (pre- and post- injection) images.
| subjects | Overall Study |
|---|---|
| Other diagnoses | 24 |
| Congenital disease/syndrome | 6 |
| No lesions/normal | 6 |
| Malignant lesions | 4 |
| Benign lesions | 2 |
| Infectious disease | 1 |
| Structural malformation | 1 |
The final diagnosis of the subjects was based on all clinical information available and was provided separately within 4 weeks after MRI. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images. Only subjects with final diagnosis were reported.
| subjects | Overall Study |
|---|---|
| Abdomen: Other | 1 |
| Chest/ thorax: Congenital disease/syndrome | 3 |
| Chest/ thorax: Infectious disease | 1 |
| Chest/ thorax: Malignant lesion | 1 |
| Chest/ thorax: No lesion/Normal | 6 |
| Chest/ thorax: Other | 2 |
| Brain: Other | 10 |
| Head/neck: Benign lesion | 1 |
| Head/neck: Malignant lesion | 1 |
| Head/neck: Other | 3 |
| Lymphatic system: Other | 1 |
| Pelvic area: Benign lesion | 1 |
| Pelvic area: Other | 1 |
| Retroperitoneal: Congenital disease/syndrome | 3 |
| Retroperitoneal: Malignant lesion | 1 |
| Retroperitoneal: Other | 3 |
| Spine: Malignant lesion | 1 |
| Spine: Other | 3 |
| Spine: Structural malformation | 1 |
The analysis value for change in diagnosis was recorded as "yes/no". Evaluation was done on pre- injection and combined (pre- and post-injection) images.
| subjects | Overall Study |
|---|---|
| No | 39 |
| Yes | 5 |
The analysis value for change in diagnosis was recorded as "yes/no". Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
| subjects | Overall Study |
|---|---|
| Abdomen: No | 1 |
| Abdomen: Yes | 0 |
| Brain: No | 20 |
| Brain: Yes | 1 |
| Chest/Thorax: No | 2 |
| Chest/Thorax: Yes | 0 |
| Head/Neck: No | 5 |
| Head/Neck: Yes | 0 |
| Lymphatic system: No | 1 |
| Lymphatic system: Yes | 0 |
| Pelvic area: No | 0 |
| Pelvic area: Yes | 2 |
| Retroperitoneal: No | 5 |
| Retroperitoneal: Yes | 2 |
| Spine: No | 5 |
| Spine: Yes | 0 |
The analysis value for change in diagnosis was recorded as "yes/no". Evaluation was done on pre- injection and combined (pre- and post-injection) images.
| subjects | Overall Study |
|---|---|
| No | 33 |
| Yes | 11 |
The analysis value for change in diagnosis was recorded as "yes/no". Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
| subjects | Overall Study |
|---|---|
| Abdomen: No | 1 |
| Abdomen: Yes | 0 |
| Brain: No | 17 |
| Brain: Yes | 4 |
| Chest/Thorax: No | 1 |
| Chest/Thorax: Yes | 1 |
| Head/Neck: No | 4 |
| Head/Neck: Yes | 1 |
| Lymphatic system: No | 0 |
| Lymphatic system: Yes | 1 |
| Pelvic area: No | 1 |
| Pelvic area: Yes | 1 |
| Retroperitoneal: No | 5 |
| Retroperitoneal: Yes | 2 |
| Spine: No | 4 |
| Spine: Yes | 1 |
The analysis value for change in diagnosis was recorded as "yes/no". Evaluation was done on pre- injection and combined (pre- and post-injection) images.
| subjects | Overall Study |
|---|---|
| No | 32 |
| Yes | 12 |
The analysis value for change in diagnosis was recorded as "yes/no". Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
| subjects | Overall Study |
|---|---|
| Abdomen: No | 1 |
| Abdomen: Yes | 0 |
| Brain: No | 16 |
| Brain: Yes | 5 |
| Chest/Thorax: No | 1 |
| Chest/Thorax: Yes | 1 |
| Head/Neck: No | 4 |
| Head/Neck: Yes | 1 |
| Lymphatic system: No | 0 |
| Lymphatic system: Yes | 1 |
| Pelvic area: No | 1 |
| Pelvic area: Yes | 1 |
| Retroperitoneal: No | 5 |
| Retroperitoneal: Yes | 2 |
| Spine: No | 4 |
| Spine: Yes | 1 |
The subject management was indicated based on the unenhanced images alone. The analysis value for change in subject management was recorded as "yes/no". Evaluation was done on pre-injection and combined (pre- and post-injection) images.
| subjects | Overall Study |
|---|---|
| No | 36 |
| Yes | 8 |
The subject management was indicated based on the unenhanced images alone. The analysis value for change in subject management was recorded as "yes/no". Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
| subjects | Overall Study |
|---|---|
| Abdomen: No | 1 |
| Abdomen: Yes | 0 |
| Brain: No | 19 |
| Brain: Yes | 2 |
| Chest/Thorax: No | 2 |
| Chest/Thorax: Yes | 0 |
| Head/Neck: No | 5 |
| Head/Neck: Yes | 0 |
| Lymphatic system: No | 1 |
| Lymphatic system: Yes | 0 |
| Pelvic area: No | 0 |
| Pelvic area: Yes | 2 |
| Retroperitoneal: No | 3 |
| Retroperitoneal: Yes | 4 |
| Spine: No | 5 |
| Spine: Yes | 0 |
Change in post-injection test values, such as resulting in a change in subject management or which were not the result of laboratory error and were considered clinically significant by the investigator was reported.
| subjects | Overall Study |
|---|---|
| Number of Subjects With Clinically Significant Abnormal Laboratory Values | 0 |
eGFR was calculated based on the Schwartz formula with blood sampling for serum creatinine (Scr) not exceeding 14 days prior to gadobutrol injection. Otherwise, the eGFR was obtained from the original Schwartz formula: eGFR = k \* height / Scr where k = 0.45 in term newborn infants \< 1 year of age, and k = 0.55 in children up to 13 years of age. If Scr was measured by an enzymatic creatinine method that had been calibrated to be traceable to Isotope dilution mass spectroscopy (IDMS), the updated Schwartz formula was used: eGFR = 0.413\*height/Scr.
| milliliter/minute/1.73 square | Overall Study |
|---|---|
| < 1 month (n=5) | 61.8 ± 19.2 |
| 1 to < 2 months (n=4) | 91.7 ± 24.8 |
| 2 to < 6 months (n=9) | 136.3 ± 67.1 |
| 6 to < 12 months (n=11) | 115.2 ± 45.9 |
| 12 to < 24 months (n=15) | 150.4 ± 33.9 |
An Adverse Event (AE) was any untoward medical occurrence in a subject who received study drug. A Serious AE (SAE) was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly, or deemed significant for any other reason. The drug-relatedness of AEs was determined by the Investigator based on his/her clinical decision based on all available information, and was based on the question whether there was a "reasonable causal relationship" to the study treatment.
| subjects | Overall Study |
|---|---|
| Any study drug-related AE | 1 |
| Any study drug-related SAE | 0 |
Collected over From baseline to approximately 7 days after injection.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Overall Study | — | 3/44 (6.8%) | 17/44 (38.6%) |
| Event | Overall Study |
|---|---|
| Infected cystInfections and infestations | 1/44 |
| Subdural empyemaInfections and infestations | 1/44 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 1/44 |
| Event | Overall Study |
|---|---|
| PyrexiaGeneral disorders | 5/44 |
| CoughRespiratory, thoracic and mediastinal disorders | 5/44 |
| NasopharyngitisInfections and infestations | 3/44 |
| VomitingGastrointestinal disorders | 2/44 |
| RhinitisInfections and infestations | 2/44 |
| Abnormal faecesGastrointestinal disorders | 1/44 |
| ConstipationGastrointestinal disorders | 1/44 |
| Catheter site erythemaGeneral disorders | 1/44 |
| Rash pustularInfections and infestations | 1/44 |
| Body temperature increasedInvestigations | 1/44 |
| Age, Continuous(months) | Overall Study |
|---|---|
| Mean | 8.8 ± 7.1 |
| Age, Customized(Participants) | Overall Study |
|---|---|
| Newborns (0-27 days) | 5 |
| Infants and toddlers (28 days-23 months) | 39 |
| Sex: Female, Male(Participants) | Overall Study |
|---|---|
| Female | 18 |
| Male | 26 |
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