Trial Outcomes & Findings for Study to Find the Appropriate Dose of a New Gadolinium-based Contrast Agent (GBCA) for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Brain and/or Spinal Cord Conditions (NCT NCT04307186)
NCT ID: NCT04307186
Last Updated: 2023-11-15
Results Overview
Overall diagnostic preference using a matched pairs approach was evaluated by 3 blinded readers using an ordinal 5-point scale (greatly prefer gadoquatrane, prefer gadoquatrane, no preference, prefer gadobutrol, greatly prefer gadobutrol). Percentage of participants and the respective Wald confidence intervals (CI) for image preference were reported for each of the 3 readers based on the 3-point preference scale (1=greatly prefer/prefer gadoquatrane, 0=no preference, -1=greatly prefer/prefer gadobutrol). If 2 or 3 readers reach the same conclusion on the recommended action (e.g. no dose adjustment needed), then this will be the recommended action taken.
COMPLETED
PHASE2
57 participants
At 5 minute post each injection
2023-11-15
Participant Flow
Study was conducted at 17 study centers in 4 countries between 18-Nov-2020 (first participant first visit) and 6-Sep-2022 (last participant last visit).
Of the 62 screened participants 5 were screening failures, resulting in 57 participants assigned to treatment who started with gadobutrol.
Participant milestones
| Measure |
Gadobutrol + Gadoquatrane
Participants received one intravenous (IV) injection of gadobutrol 0.1 millimole(s) gadolinium/kilogram body weight (mmol Gd/kg bw) during treatment Period 1 and one IV injection of gadoquatrane (BAY1747846) 0.04 mmol Gd/kg bw during treatment Period 2.
|
|---|---|
|
Period 1 - Gadobutrol
STARTED
|
57
|
|
Period 1 - Gadobutrol
COMPLETED
|
56
|
|
Period 1 - Gadobutrol
NOT COMPLETED
|
1
|
|
Washout 3-14 Days
STARTED
|
56
|
|
Washout 3-14 Days
COMPLETED
|
53
|
|
Washout 3-14 Days
NOT COMPLETED
|
3
|
|
Period 2 - Gadoquatrane
STARTED
|
53
|
|
Period 2 - Gadoquatrane
COMPLETED
|
52
|
|
Period 2 - Gadoquatrane
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Gadobutrol + Gadoquatrane
Participants received one intravenous (IV) injection of gadobutrol 0.1 millimole(s) gadolinium/kilogram body weight (mmol Gd/kg bw) during treatment Period 1 and one IV injection of gadoquatrane (BAY1747846) 0.04 mmol Gd/kg bw during treatment Period 2.
|
|---|---|
|
Period 1 - Gadobutrol
Withdrawal by Subject
|
1
|
|
Washout 3-14 Days
Withdrawal by Subject
|
1
|
|
Washout 3-14 Days
Progressive disease
|
1
|
|
Washout 3-14 Days
Pre-specified withdrawal criterion met
|
1
|
|
Period 2 - Gadoquatrane
Protocol Violation
|
1
|
Baseline Characteristics
Study to Find the Appropriate Dose of a New Gadolinium-based Contrast Agent (GBCA) for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Brain and/or Spinal Cord Conditions
Baseline characteristics by cohort
| Measure |
Gadobutrol + Gadoquatrane
n=57 Participants
Participants received one intravenous (IV) injection of gadobutrol 0.1 millimole(s) gadolinium/kilogram body weight (mmol Gd/kg bw) during treatment Period 1 and one IV injection of gadoquatrane (BAY1747846) 0.04 mmol Gd/kg bw during treatment Period 2.
|
|---|---|
|
Age, Continuous
|
55.9 Years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 5 minute post each injectionPopulation: Full analysis set (FAS): All participants who have completed magnetic resonance (MR) image datasets that qualify for blinded read.
Overall diagnostic preference using a matched pairs approach was evaluated by 3 blinded readers using an ordinal 5-point scale (greatly prefer gadoquatrane, prefer gadoquatrane, no preference, prefer gadobutrol, greatly prefer gadobutrol). Percentage of participants and the respective Wald confidence intervals (CI) for image preference were reported for each of the 3 readers based on the 3-point preference scale (1=greatly prefer/prefer gadoquatrane, 0=no preference, -1=greatly prefer/prefer gadobutrol). If 2 or 3 readers reach the same conclusion on the recommended action (e.g. no dose adjustment needed), then this will be the recommended action taken.
Outcome measures
| Measure |
Gadobutrol + Gadoquatrane
n=50 Participants
Participants received one intravenous (IV) injection of gadobutrol 0.1 millimole(s) gadolinium/kilogram body weight (mmol Gd/kg bw) during treatment Period 1 and one IV injection of gadoquatrane (BAY1747846) 0.04 mmol Gd/kg bw during treatment Period 2.
|
Gadoquatrane Post-contrast
MR images were taken 5 min after receiving IV injection of gadoquatrane.
|
Gadoquatrane Pre-contrast
MR images were taken before receiving IV injection of gadoquatrane.
|
Gadoquatrane Combined Pre- and Post-contrast
Evaluation of the combined MR image sets taken before and 5 min after receiving IV injection of gadoquatrane.
|
|---|---|---|---|---|
|
Overall Diagnostic Preference
Reader 1 (1)
|
10 Percentage of participants
Interval 1.68 to 18.32
|
—
|
—
|
—
|
|
Overall Diagnostic Preference
Reader 1 (0)
|
34 Percentage of participants
Interval 20.87 to 47.13
|
—
|
—
|
—
|
|
Overall Diagnostic Preference
Reader 1 (-1)
|
56 Percentage of participants
Interval 42.24 to 69.76
|
—
|
—
|
—
|
|
Overall Diagnostic Preference
Reader 2 (1)
|
26 Percentage of participants
Interval 13.84 to 38.16
|
—
|
—
|
—
|
|
Overall Diagnostic Preference
Reader 2 (0)
|
42 Percentage of participants
Interval 28.32 to 55.68
|
—
|
—
|
—
|
|
Overall Diagnostic Preference
Reader 2 (-1)
|
32 Percentage of participants
Interval 19.07 to 44.93
|
—
|
—
|
—
|
|
Overall Diagnostic Preference
Reader 3 (1)
|
30 Percentage of participants
Interval 17.3 to 42.7
|
—
|
—
|
—
|
|
Overall Diagnostic Preference
Reader 3 (0)
|
28 Percentage of participants
Interval 15.55 to 40.45
|
—
|
—
|
—
|
|
Overall Diagnostic Preference
Reader 3 (-1)
|
42 Percentage of participants
Interval 28.32 to 55.68
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 5 minute post each injectionPopulation: Full analysis set (FAS): All participants who have completed magnetic resonance image datasets that qualify for blinded read.
The 3 lesion visualization parameters (border delineation/degree of contrast enhancement/internal morphology) were combined by adding them up for each participant and each blinded reader, leading to only one variable on an ordinal 11-point scale (the higher values represent a better lesion visualization). Average reader was the mean of the 3 blinded readers averages of the scores per participant. Lesion border delineation: measured on a 4-point scale (1=None \[no/unclear delineation of the lesion boundaries\] to 4=Excellent \[clear and complete delineation\]). Degree of lesion contrast enhancement: measured on a 4-point scale (1=No \[lesion is not enhanced\] to 4=Excellent \[lesion is clearly and brightly enhanced\]). Lesion internal morphology: measured on a 3-point scale (1=Poor \[structure and internal morphology of the lesion is poorly visible\] to 3=Good \[structure and internal morphology of the lesion is sufficiently visible\]).
Outcome measures
| Measure |
Gadobutrol + Gadoquatrane
n=50 Participants
Participants received one intravenous (IV) injection of gadobutrol 0.1 millimole(s) gadolinium/kilogram body weight (mmol Gd/kg bw) during treatment Period 1 and one IV injection of gadoquatrane (BAY1747846) 0.04 mmol Gd/kg bw during treatment Period 2.
|
Gadoquatrane Post-contrast
n=50 Participants
MR images were taken 5 min after receiving IV injection of gadoquatrane.
|
Gadoquatrane Pre-contrast
MR images were taken before receiving IV injection of gadoquatrane.
|
Gadoquatrane Combined Pre- and Post-contrast
Evaluation of the combined MR image sets taken before and 5 min after receiving IV injection of gadoquatrane.
|
|---|---|---|---|---|
|
Sum of Lesion Visualization Parameters on Post-contrast Images
Reader 1
|
9.95 Scores on a scale
Standard Deviation 1.447
|
9.67 Scores on a scale
Standard Deviation 1.541
|
—
|
—
|
|
Sum of Lesion Visualization Parameters on Post-contrast Images
Reader 2
|
7.67 Scores on a scale
Standard Deviation 1.292
|
7.49 Scores on a scale
Standard Deviation 1.406
|
—
|
—
|
|
Sum of Lesion Visualization Parameters on Post-contrast Images
Reader 3
|
9.28 Scores on a scale
Standard Deviation 1.877
|
9.65 Scores on a scale
Standard Deviation 1.598
|
—
|
—
|
|
Sum of Lesion Visualization Parameters on Post-contrast Images
Average reader
|
9.00 Scores on a scale
Standard Deviation 1.294
|
8.94 Scores on a scale
Standard Deviation 1.229
|
—
|
—
|
SECONDARY outcome
Timeframe: At pre-injection and 5 minute post each injectionPopulation: Full analysis set (FAS): All participants who have completed magnetic resonance image datasets that qualify for blinded read.
Lesion border delineation: up to 5 of the largest lesions were selected and scored using a 4-point scale (1=None \[no/unclear delineation of the lesion boundaries\] to 4=Excellent \[clear and complete delineation\]; the higher values represent a better lesion border delineation). Average reader was the mean of the 3 blinded readers averages of the scores per participant.
Outcome measures
| Measure |
Gadobutrol + Gadoquatrane
n=50 Participants
Participants received one intravenous (IV) injection of gadobutrol 0.1 millimole(s) gadolinium/kilogram body weight (mmol Gd/kg bw) during treatment Period 1 and one IV injection of gadoquatrane (BAY1747846) 0.04 mmol Gd/kg bw during treatment Period 2.
|
Gadoquatrane Post-contrast
n=50 Participants
MR images were taken 5 min after receiving IV injection of gadoquatrane.
|
Gadoquatrane Pre-contrast
n=50 Participants
MR images were taken before receiving IV injection of gadoquatrane.
|
Gadoquatrane Combined Pre- and Post-contrast
n=50 Participants
Evaluation of the combined MR image sets taken before and 5 min after receiving IV injection of gadoquatrane.
|
|---|---|---|---|---|
|
Lesion Visualization Parameter Border Delineation on Pre-contrast and Combined Pre- and Post-contrast Images
Reader 1
|
1.83 Scores on a scale
Standard Deviation 0.701
|
3.39 Scores on a scale
Standard Deviation 0.936
|
1.88 Scores on a scale
Standard Deviation 0.698
|
3.28 Scores on a scale
Standard Deviation 0.970
|
|
Lesion Visualization Parameter Border Delineation on Pre-contrast and Combined Pre- and Post-contrast Images
Reader 2
|
1.70 Scores on a scale
Standard Deviation 0.509
|
2.45 Scores on a scale
Standard Deviation 0.589
|
1.67 Scores on a scale
Standard Deviation 0.469
|
2.39 Scores on a scale
Standard Deviation 0.576
|
|
Lesion Visualization Parameter Border Delineation on Pre-contrast and Combined Pre- and Post-contrast Images
Reader 3
|
1.98 Scores on a scale
Standard Deviation 0.423
|
3.28 Scores on a scale
Standard Deviation 0.751
|
1.87 Scores on a scale
Standard Deviation 0.403
|
3.21 Scores on a scale
Standard Deviation 0.873
|
|
Lesion Visualization Parameter Border Delineation on Pre-contrast and Combined Pre- and Post-contrast Images
Average reader
|
1.82 Scores on a scale
Standard Deviation 0.438
|
3.02 Scores on a scale
Standard Deviation 0.614
|
1.81 Scores on a scale
Standard Deviation 0.394
|
2.91 Scores on a scale
Standard Deviation 0.609
|
SECONDARY outcome
Timeframe: At pre-injection and 5 minute post each injectionPopulation: Full analysis set (FAS): All participants who have completed magnetic resonance image datasets that qualify for blinded read.
Degree of lesion contrast enhancement: up to the 5 largest lesions were selected and scored using a 4-point scale (1=No \[lesion is not enhanced\] to 4=Excellent \[lesion is clearly and brightly enhanced\]; the higher values represent a better degree of lesion contrast enhancement). Average reader was the mean of the 3 blinded readers averages of the scores per participant.
Outcome measures
| Measure |
Gadobutrol + Gadoquatrane
n=50 Participants
Participants received one intravenous (IV) injection of gadobutrol 0.1 millimole(s) gadolinium/kilogram body weight (mmol Gd/kg bw) during treatment Period 1 and one IV injection of gadoquatrane (BAY1747846) 0.04 mmol Gd/kg bw during treatment Period 2.
|
Gadoquatrane Post-contrast
n=50 Participants
MR images were taken 5 min after receiving IV injection of gadoquatrane.
|
Gadoquatrane Pre-contrast
n=50 Participants
MR images were taken before receiving IV injection of gadoquatrane.
|
Gadoquatrane Combined Pre- and Post-contrast
n=50 Participants
Evaluation of the combined MR image sets taken before and 5 min after receiving IV injection of gadoquatrane.
|
|---|---|---|---|---|
|
Lesion Visualization Parameter Contrast Enhancement on Pre-contrast and Combined Pre- and Post-contrast Images
Reader 1
|
1.00 Scores on a scale
Standard Deviation 0.000
|
3.24 Scores on a scale
Standard Deviation 0.917
|
1.00 Scores on a scale
Standard Deviation 0.000
|
3.20 Scores on a scale
Standard Deviation 0.825
|
|
Lesion Visualization Parameter Contrast Enhancement on Pre-contrast and Combined Pre- and Post-contrast Images
Reader 2
|
1.00 Scores on a scale
Standard Deviation 0.000
|
2.50 Scores on a scale
Standard Deviation 0.629
|
1.00 Scores on a scale
Standard Deviation 0.000
|
2.57 Scores on a scale
Standard Deviation 0.587
|
|
Lesion Visualization Parameter Contrast Enhancement on Pre-contrast and Combined Pre- and Post-contrast Images
Reader 3
|
1.00 Scores on a scale
Standard Deviation 0.000
|
3.55 Scores on a scale
Standard Deviation 0.904
|
0.99 Scores on a scale
Standard Deviation 0.078
|
3.49 Scores on a scale
Standard Deviation 0.925
|
|
Lesion Visualization Parameter Contrast Enhancement on Pre-contrast and Combined Pre- and Post-contrast Images
Average Reader
|
1.00 Scores on a scale
Standard Deviation 0.000
|
3.07 Scores on a scale
Standard Deviation 0.638
|
1.00 Scores on a scale
Standard Deviation 0.027
|
3.05 Scores on a scale
Standard Deviation 0.600
|
SECONDARY outcome
Timeframe: At pre-injection and 5 minute post each injectionPopulation: Full analysis set (FAS): All participants who have completed magnetic resonance image datasets that qualify for blinded read.
Lesion internal morphology: up to 5 of the largest lesions were selected and scored using a 3-point scale (1=Poor \[structure and internal morphology of the lesion is poorly visible\] to 3=Good \[structure and internal morphology of the lesion is sufficiently visible\]; the higher values represent a better lesion internal morphology). Average reader was the mean of the 3 blinded readers averages of the scores per participant.
Outcome measures
| Measure |
Gadobutrol + Gadoquatrane
n=50 Participants
Participants received one intravenous (IV) injection of gadobutrol 0.1 millimole(s) gadolinium/kilogram body weight (mmol Gd/kg bw) during treatment Period 1 and one IV injection of gadoquatrane (BAY1747846) 0.04 mmol Gd/kg bw during treatment Period 2.
|
Gadoquatrane Post-contrast
n=50 Participants
MR images were taken 5 min after receiving IV injection of gadoquatrane.
|
Gadoquatrane Pre-contrast
n=50 Participants
MR images were taken before receiving IV injection of gadoquatrane.
|
Gadoquatrane Combined Pre- and Post-contrast
n=50 Participants
Evaluation of the combined MR image sets taken before and 5 min after receiving IV injection of gadoquatrane.
|
|---|---|---|---|---|
|
Lesion Visualization Parameter Internal Morphology on Pre-contrast and Combined Pre- and Post-contrast Images
Average Reader
|
1.13 Scores on a scale
Standard Deviation 0.194
|
2.39 Scores on a scale
Standard Deviation 0.493
|
1.16 Scores on a scale
Standard Deviation 0.218
|
2.35 Scores on a scale
Standard Deviation 0.500
|
|
Lesion Visualization Parameter Internal Morphology on Pre-contrast and Combined Pre- and Post-contrast Images
Reader 1
|
1.27 Scores on a scale
Standard Deviation 0.444
|
2.62 Scores on a scale
Standard Deviation 0.693
|
1.40 Scores on a scale
Standard Deviation 0.484
|
2.58 Scores on a scale
Standard Deviation 0.655
|
|
Lesion Visualization Parameter Internal Morphology on Pre-contrast and Combined Pre- and Post-contrast Images
Reader 2
|
1.05 Scores on a scale
Standard Deviation 0.185
|
2.13 Scores on a scale
Standard Deviation 0.598
|
1.05 Scores on a scale
Standard Deviation 0.211
|
2.11 Scores on a scale
Standard Deviation 0.689
|
|
Lesion Visualization Parameter Internal Morphology on Pre-contrast and Combined Pre- and Post-contrast Images
Reader 3
|
1.05 Scores on a scale
Standard Deviation 0.221
|
2.45 Scores on a scale
Standard Deviation 0.677
|
1.04 Scores on a scale
Standard Deviation 0.234
|
2.44 Scores on a scale
Standard Deviation 0.673
|
SECONDARY outcome
Timeframe: At pre-injection and 5 minute post injectionPopulation: Full analysis set (FAS): All participants who have completed magnetic resonance image datasets that qualify for blinded read.
The 3 blinded readers recorded the total number of lesions for each pre-contrast and combined pre- and post-contrast magnetic resonance image set separately. The numbers of participants by number of detected lesions were reported.
Outcome measures
| Measure |
Gadobutrol + Gadoquatrane
n=50 Participants
Participants received one intravenous (IV) injection of gadobutrol 0.1 millimole(s) gadolinium/kilogram body weight (mmol Gd/kg bw) during treatment Period 1 and one IV injection of gadoquatrane (BAY1747846) 0.04 mmol Gd/kg bw during treatment Period 2.
|
Gadoquatrane Post-contrast
n=50 Participants
MR images were taken 5 min after receiving IV injection of gadoquatrane.
|
Gadoquatrane Pre-contrast
n=50 Participants
MR images were taken before receiving IV injection of gadoquatrane.
|
Gadoquatrane Combined Pre- and Post-contrast
n=50 Participants
Evaluation of the combined MR image sets taken before and 5 min after receiving IV injection of gadoquatrane.
|
|---|---|---|---|---|
|
Number of Lesions on Pre-contrast and Combined Pre- and Post-contrast Images
Reader 3 (Nr. of lesions=3)
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Lesions on Pre-contrast and Combined Pre- and Post-contrast Images
Reader 3 (Nr. of lesions=4)
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Lesions on Pre-contrast and Combined Pre- and Post-contrast Images
Reader 3 (Nr. of lesions=2)
|
0 Participants
|
7 Participants
|
1 Participants
|
4 Participants
|
|
Number of Lesions on Pre-contrast and Combined Pre- and Post-contrast Images
Reader 1 (Nr. of lesions=3)
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Lesions on Pre-contrast and Combined Pre- and Post-contrast Images
Reader 2 (Nr. of lesions=0)
|
4 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
|
Number of Lesions on Pre-contrast and Combined Pre- and Post-contrast Images
Reader 2 (Nr. of lesions=1)
|
42 Participants
|
43 Participants
|
42 Participants
|
43 Participants
|
|
Number of Lesions on Pre-contrast and Combined Pre- and Post-contrast Images
Reader 2 (Nr. of lesions=2)
|
0 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
|
Number of Lesions on Pre-contrast and Combined Pre- and Post-contrast Images
Reader 2 (Nr. of lesions=3)
|
2 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Number of Lesions on Pre-contrast and Combined Pre- and Post-contrast Images
Reader 3 (Nr. of lesions=0)
|
10 Participants
|
1 Participants
|
9 Participants
|
1 Participants
|
|
Number of Lesions on Pre-contrast and Combined Pre- and Post-contrast Images
Reader 3 (Nr. of lesions=1)
|
40 Participants
|
41 Participants
|
40 Participants
|
42 Participants
|
|
Number of Lesions on Pre-contrast and Combined Pre- and Post-contrast Images
Reader 1 (Nr. of lesions=0)
|
4 Participants
|
1 Participants
|
7 Participants
|
1 Participants
|
|
Number of Lesions on Pre-contrast and Combined Pre- and Post-contrast Images
Reader 1 (Nr. of lesions=1)
|
43 Participants
|
40 Participants
|
40 Participants
|
41 Participants
|
|
Number of Lesions on Pre-contrast and Combined Pre- and Post-contrast Images
Reader 1 (Nr. of lesions=2)
|
3 Participants
|
7 Participants
|
1 Participants
|
6 Participants
|
Adverse Events
Gadobutrol
Gadoquatrane
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Gadobutrol
n=57 participants at risk
Participants received one intravenous (IV) injection of gadobutrol 0.1 millimole(s) gadolinium/kilogram body weight (mmol Gd/kg bw) during treatment Period 1.
|
Gadoquatrane
n=52 participants at risk
Participants received one IV injection of gadoquatrane (BAY1747846) 0.04 mmol Gd/kg bw during treatment Period 2.
|
|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
1.8%
1/57 • Number of events 1 • Adverse events tables: up to the 24 h ± 4 h follow-up time point following Gadobutrol or Gadoquatrane injection. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 36 days.
|
0.00%
0/52 • Adverse events tables: up to the 24 h ± 4 h follow-up time point following Gadobutrol or Gadoquatrane injection. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 36 days.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/57 • Adverse events tables: up to the 24 h ± 4 h follow-up time point following Gadobutrol or Gadoquatrane injection. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 36 days.
|
1.9%
1/52 • Number of events 1 • Adverse events tables: up to the 24 h ± 4 h follow-up time point following Gadobutrol or Gadoquatrane injection. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 36 days.
|
|
General disorders
Injection site bruising
|
1.8%
1/57 • Number of events 1 • Adverse events tables: up to the 24 h ± 4 h follow-up time point following Gadobutrol or Gadoquatrane injection. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 36 days.
|
0.00%
0/52 • Adverse events tables: up to the 24 h ± 4 h follow-up time point following Gadobutrol or Gadoquatrane injection. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 36 days.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.8%
1/57 • Number of events 1 • Adverse events tables: up to the 24 h ± 4 h follow-up time point following Gadobutrol or Gadoquatrane injection. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 36 days.
|
1.9%
1/52 • Number of events 1 • Adverse events tables: up to the 24 h ± 4 h follow-up time point following Gadobutrol or Gadoquatrane injection. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 36 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A written manuscript of any oral/written publication relating to the trial, the investigational medicinal products or the results shall be submitted to Bayer for review at least 60 days before the planned filing or presentation of the publication. If Bayer does not confirm receipt of the intended publication within 45 days, Bayer must be informed again of the intended publication date. If Bayer does not comment on the publication within the 60-day period, the publication is free to be published.
- Publication restrictions are in place
Restriction type: OTHER