Trial Outcomes & Findings for A Study to Compare How Well Gadoquatrane Works and Its Safety With an Already Available Contrast Agent for MRI in People With Any Known or Suspected Problems of the Body (Except Brain or Spinal Cord-related Problems) (NCT NCT05915728)
NCT ID: NCT05915728
Last Updated: 2026-08-20
Results Overview
Contrast Enhancement was assessed on a 4-point scale (1/No: not enhanced, 2/Moderate: weakly enhanced, 3/Good: clearly enhanced, 4/Excellent: clearly and brightly enhanced). BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
410 participants
Primary outcome timeframe
1 day procedure
Results posted on
2026-08-20
Participant Flow
This study was conducted at 75 centers in Europe, Asia Pacific, North America, and South America from 24 July 2023 (first patient first visit) to 01 June 2024 (last patient last visit).
During period 1 of the cross-over, each participant was randomized in a 1:1 ratio to first receive either gadoquatrane or comparator (gadobutrol, gadoterate meglumine/ gadoteric acid, or gadoteridol). After a wash-out period, of at least 72 hours, participants switched treatments in a blinder manner for Period 2, which was performed 72 hours to 14 days after Period 1.
Participant milestones
| Measure |
Gadoquatrane - SoC GBCAs
In Period 1, participants received gadoquatrane 0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose.
In Period 2, participants received an approved standard of care (SoC) macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
SoC GBCAs - Gadoquatrane
In Period 1, participants received an approved standard of care (SoC) macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
In Period 2, participants received gadoquatrane 0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
|---|---|---|
|
Period 1
STARTED
|
206
|
204
|
|
Period 1
Treated
|
201
|
204
|
|
Period 1
COMPLETED
|
198
|
197
|
|
Period 1
NOT COMPLETED
|
8
|
7
|
|
Period 2
STARTED
|
198
|
197
|
|
Period 2
Treated
|
196
|
197
|
|
Period 2
COMPLETED
|
194
|
192
|
|
Period 2
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
Gadoquatrane - SoC GBCAs
In Period 1, participants received gadoquatrane 0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose.
In Period 2, participants received an approved standard of care (SoC) macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
SoC GBCAs - Gadoquatrane
In Period 1, participants received an approved standard of care (SoC) macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
In Period 2, participants received gadoquatrane 0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
|---|---|---|
|
Period 1
Participant decision
|
2
|
7
|
|
Period 1
Other reasons
|
1
|
0
|
|
Period 1
Study drug never administered
|
5
|
0
|
|
Period 2
Participant decision
|
2
|
5
|
|
Period 2
Physician Decision
|
1
|
0
|
|
Period 2
Randomized by mistake
|
1
|
0
|
Baseline Characteristics
A Study to Compare How Well Gadoquatrane Works and Its Safety With an Already Available Contrast Agent for MRI in People With Any Known or Suspected Problems of the Body (Except Brain or Spinal Cord-related Problems)
Baseline characteristics by cohort
| Measure |
Gadoquatrane - SoC GBCAs
n=201 Participants
In Period 1, participants received gadoquatrane 0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose.
In Period 2, participants received an approved standard of care (SoC) macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
SoC GBCAs - Gadoquatrane
n=204 Participants
In Period 1, participants received an approved standard of care (SoC) macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
In Period 2, participants received gadoquatrane 0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
Total
n=405 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.7 Years
STANDARD_DEVIATION 15.5 • n=5 Participants
|
56.7 Years
STANDARD_DEVIATION 14.4 • n=109 Participants
|
56.2 Years
STANDARD_DEVIATION 15.0 • n=133 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=5 Participants
|
102 Participants
n=109 Participants
|
207 Participants
n=133 Participants
|
|
Sex: Female, Male
Male
|
96 Participants
n=5 Participants
|
102 Participants
n=109 Participants
|
198 Participants
n=133 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=5 Participants
|
2 Participants
n=109 Participants
|
2 Participants
n=133 Participants
|
|
Race/Ethnicity, Customized
Asian
|
53 Participants
n=5 Participants
|
55 Participants
n=109 Participants
|
108 Participants
n=133 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=109 Participants
|
3 Participants
n=133 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=109 Participants
|
1 Participants
n=133 Participants
|
|
Race/Ethnicity, Customized
White
|
144 Participants
n=5 Participants
|
138 Participants
n=109 Participants
|
282 Participants
n=133 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
2 Participants
n=5 Participants
|
7 Participants
n=109 Participants
|
9 Participants
n=133 Participants
|
PRIMARY outcome
Timeframe: 1 day procedurePopulation: Full Analysis Set 1 (FAS1): All randomized participants who have: (i) CE-MRI image sets that qualify for blinded reads, (ii) both pre-contrast and combined pre- and post gadoquatrane image sets assessable, and (iii) at least one matching lesion for at least one central reader.
Contrast Enhancement was assessed on a 4-point scale (1/No: not enhanced, 2/Moderate: weakly enhanced, 3/Good: clearly enhanced, 4/Excellent: clearly and brightly enhanced). BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging
Outcome measures
| Measure |
Gadoquatrane
n=312 Participants
Participants received gadoquatrane 0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
SoC GBCAs
n=312 Participants
Participants received an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
SoC GBCAs
Participants received an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
Pre-SoC GBCAs
Participants had an MRI image scan prior to the injection of an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol).
|
|---|---|---|---|---|
|
Visualization Parameter Contrast Enhancement Assessed by Separate Blinded Evaluation of Unenhanced and Combined Pre- and Post-gadoquatrane MRI, by a BICR
Reader 1
|
3.873 Score
Standard Deviation 0.500
|
1.018 Score
Standard Deviation 0.214
|
—
|
—
|
|
Visualization Parameter Contrast Enhancement Assessed by Separate Blinded Evaluation of Unenhanced and Combined Pre- and Post-gadoquatrane MRI, by a BICR
Reader 2
|
3.433 Score
Standard Deviation 1.128
|
1.058 Score
Standard Deviation 0.340
|
—
|
—
|
|
Visualization Parameter Contrast Enhancement Assessed by Separate Blinded Evaluation of Unenhanced and Combined Pre- and Post-gadoquatrane MRI, by a BICR
Reader 3
|
3.381 Score
Standard Deviation 0.665
|
1.023 Score
Standard Deviation 0.241
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 day procedurePopulation: Full Analysis Set 1 (FAS1) : All randomized participants who have: (i) CE-MRI image sets that qualify for blinded reads, (ii) both pre-contrast and combined pre- and post gadoquatrane image sets assessable, and (iii) at least one matching lesion for at least one central reader.
Delineation was assessed on a 4-point scale (1/No: no or unclear delineation, 2/Moderate: some aspects of delineation, 3/Good: almost clear but not complete, 4/Excellent: clear and complete delineation). BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging
Outcome measures
| Measure |
Gadoquatrane
n=312 Participants
Participants received gadoquatrane 0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
SoC GBCAs
n=312 Participants
Participants received an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
SoC GBCAs
Participants received an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
Pre-SoC GBCAs
Participants had an MRI image scan prior to the injection of an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol).
|
|---|---|---|---|---|
|
Visualization Parameter Delineation Assessed by Separate Blinded Evaluation of Unenhanced and Combined Pre- and Post-gadoquatrane MRI, by a BICR
Reader 1
|
3.916 Score
Standard Deviation 0.366
|
1.220 Score
Standard Deviation 0.573
|
—
|
—
|
|
Visualization Parameter Delineation Assessed by Separate Blinded Evaluation of Unenhanced and Combined Pre- and Post-gadoquatrane MRI, by a BICR
Reader 2
|
3.906 Score
Standard Deviation 0.332
|
2.895 Score
Standard Deviation 0.559
|
—
|
—
|
|
Visualization Parameter Delineation Assessed by Separate Blinded Evaluation of Unenhanced and Combined Pre- and Post-gadoquatrane MRI, by a BICR
Reader 3
|
3.503 Score
Standard Deviation 0.667
|
1.786 Score
Standard Deviation 0.847
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 day procedurePopulation: Full Analysis Set 1 (FAS1): All randomized participants who have: (i) CE-MRI image sets that qualify for blinded reads, (ii) both pre-contrast and combined pre- and post gadoquatrane image sets assessable, and (iii) at least one matching lesion for at least one central reader.
Morphology was assessed on a 3-point scale (1/Poor: no or poorly evaluable, 2/Moderate: partially evaluable, 3/Good: sufficiently evaluable). BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging
Outcome measures
| Measure |
Gadoquatrane
n=312 Participants
Participants received gadoquatrane 0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
SoC GBCAs
n=312 Participants
Participants received an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
SoC GBCAs
Participants received an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
Pre-SoC GBCAs
Participants had an MRI image scan prior to the injection of an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol).
|
|---|---|---|---|---|
|
Visualization Parameter Morphology Assessed by Separate Blinded Evaluation of Unenhanced and Combined Pre- and Post-gadoquatrane MRI, by a BICR
Reader 1
|
2.983 Score
Standard Deviation 0.167
|
1.149 Score
Standard Deviation 0.422
|
—
|
—
|
|
Visualization Parameter Morphology Assessed by Separate Blinded Evaluation of Unenhanced and Combined Pre- and Post-gadoquatrane MRI, by a BICR
Reader 2
|
2.923 Score
Standard Deviation 0.326
|
2.032 Score
Standard Deviation 0.561
|
—
|
—
|
|
Visualization Parameter Morphology Assessed by Separate Blinded Evaluation of Unenhanced and Combined Pre- and Post-gadoquatrane MRI, by a BICR
Reader 3
|
2.899 Score
Standard Deviation 0.366
|
1.195 Score
Standard Deviation 0.456
|
—
|
—
|
SECONDARY outcome
Timeframe: Two MRI examinations with an interval of 3-14 days between themPopulation: Full Analysis Set 2 (FAS2): All randomized participants who have: (i) CE-MRI image sets that qualify for blinded reads; (ii) have both gadoquatrane and SoC comparator combined pre- and post- contrast image sets assessable; and (iii) at least one matching lesion for at least one central reader.
Contrast Enhancement was assessed on a 4-point scale (1/No: not enhanced, 2/Moderate: weakly enhanced, 3/Good: clearly enhanced, 4/Excellent: clearly and brightly enhanced). BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agents
Outcome measures
| Measure |
Gadoquatrane
n=308 Participants
Participants received gadoquatrane 0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
SoC GBCAs
n=308 Participants
Participants received an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
SoC GBCAs
Participants received an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
Pre-SoC GBCAs
Participants had an MRI image scan prior to the injection of an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol).
|
|---|---|---|---|---|
|
Visualization Parameter Contrast Assessed by Separate Blinded Evaluation of Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs, by a BICR
Reader 1
|
3.591 Score
Standard Error 0.054
|
3.517 Score
Standard Error 0.055
|
—
|
—
|
|
Visualization Parameter Contrast Assessed by Separate Blinded Evaluation of Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs, by a BICR
Reader 2
|
3.100 Score
Standard Error 0.054
|
3.094 Score
Standard Error 0.054
|
—
|
—
|
|
Visualization Parameter Contrast Assessed by Separate Blinded Evaluation of Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs, by a BICR
Reader 3
|
3.185 Score
Standard Error 0.054
|
3.125 Score
Standard Error 0.054
|
—
|
—
|
SECONDARY outcome
Timeframe: Two MRI examinations with an interval of 3-14 days between themPopulation: Full Analysis Set 2 (FAS2): All randomized participants who have: (i) CE-MRI image sets that qualify for blinded reads; (ii) have both gadoquatrane and SoC comparator combined pre- and post- contrast image sets assessable; and (iii) at least one matching lesion for at least one central reader.
Delineation was assessed on a 4-point scale (1/No: no or unclear delineation, 2/Moderate: some aspects of delineation, 3/Good: almost clear but not complete, 4/Excellent: clear and complete delineation). BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agents
Outcome measures
| Measure |
Gadoquatrane
n=308 Participants
Participants received gadoquatrane 0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
SoC GBCAs
n=308 Participants
Participants received an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
SoC GBCAs
Participants received an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
Pre-SoC GBCAs
Participants had an MRI image scan prior to the injection of an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol).
|
|---|---|---|---|---|
|
Visualization Parameter Delineation Assessed by Separate Blinded Evaluation of Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs, by a BICR
Reader 1
|
3.656 Score
Standard Error 0.044
|
3.582 Score
Standard Error 0.044
|
—
|
—
|
|
Visualization Parameter Delineation Assessed by Separate Blinded Evaluation of Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs, by a BICR
Reader 2
|
3.627 Score
Standard Error 0.043
|
3.662 Score
Standard Error 0.043
|
—
|
—
|
|
Visualization Parameter Delineation Assessed by Separate Blinded Evaluation of Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs, by a BICR
Reader 3
|
3.344 Score
Standard Error 0.044
|
3.275 Score
Standard Error 0.044
|
—
|
—
|
SECONDARY outcome
Timeframe: Two MRI examinations with an interval of 3-14 days between themPopulation: Full Analysis Set 2 (FAS2): All randomized participants who have: (i) CE-MRI image sets that qualify for blinded reads; (ii) have both gadoquatrane and SoC comparator combined pre- and post- contrast image sets assessable; and (iii) at least one matching lesion for at least one central reader.
Morphology was assessed on a 3-point scale (1/Poor: no or poorly evaluable, 2/Moderate: partially evaluable, 3/Good: sufficiently evaluable). BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agents
Outcome measures
| Measure |
Gadoquatrane
n=308 Participants
Participants received gadoquatrane 0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
SoC GBCAs
n=308 Participants
Participants received an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
SoC GBCAs
Participants received an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
Pre-SoC GBCAs
Participants had an MRI image scan prior to the injection of an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol).
|
|---|---|---|---|---|
|
Visualization Parameter Morphology Assessed by Separate Blinded Evaluation of Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs, by a BICR
Reader 1
|
2.820 Score
Standard Error 0.030
|
2.754 Score
Standard Error 0.031
|
—
|
—
|
|
Visualization Parameter Morphology Assessed by Separate Blinded Evaluation of Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs, by a BICR
Reader 2
|
2.737 Score
Standard Error 0.030
|
2.722 Score
Standard Error 0.030
|
—
|
—
|
|
Visualization Parameter Morphology Assessed by Separate Blinded Evaluation of Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs, by a BICR
Reader 3
|
2.753 Score
Standard Error 0.030
|
2.715 Score
Standard Error 0.030
|
—
|
—
|
SECONDARY outcome
Timeframe: Two MRI examinations with an interval of 3-14 days between themPopulation: Extended Full Analysis Set (Extended-FAS): All randomized subjects who had CE-MRI/MRA image sets that qualify for blinded reads and had both gadoquatrane and SoC comparator combined pre- and post- contrast image sets assessable. The Extended-FAS comprises 378 participants. While cases lacking a definitive cSoT diagnosis for either the SoC or Gadoquatrane were excluded from this assessment, it should be noted that these participants remain eligible for inclusion in the primary analysis population
Sensitivity for the detection of lesions was evaluated by blinded independent central review (BICR) readers using combined pre- and post-contrast MRI image sets for gadoquatrane and comparator macrocyclic GBCAs. A lesion was defined as a localized, clinically relevant pathological change in a tissue due to injury or disease. In the context of imaging, it was defined as the localization of a pathology which might have been visualized on the MRI. The result from the BICR was then matched with the information from the composite Standard of Truth (cSoT). The cSoT was determined up to 4 weeks after second study related MRI based on the totality of the available clinical information by the referring physician.
Outcome measures
| Measure |
Gadoquatrane
n=378 Participants
Participants received gadoquatrane 0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
SoC GBCAs
n=378 Participants
Participants received an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
SoC GBCAs
Participants received an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
Pre-SoC GBCAs
Participants had an MRI image scan prior to the injection of an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol).
|
|---|---|---|---|---|
|
Sensitivity for the Detection of Lesions of Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs, by a BICR
Reader 1
|
85.27 % sensitivity
Interval 81.38 to 89.16
|
85.89 % sensitivity
Interval 82.07 to 89.71
|
—
|
—
|
|
Sensitivity for the Detection of Lesions of Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs, by a BICR
Reader 2
|
89.66 % sensitivity
Interval 86.31 to 93.0
|
89.03 % sensitivity
Interval 85.6 to 92.46
|
—
|
—
|
|
Sensitivity for the Detection of Lesions of Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs, by a BICR
Reader 3
|
86.83 % sensitivity
Interval 83.12 to 90.54
|
88.71 % sensitivity
Interval 85.24 to 92.19
|
—
|
—
|
SECONDARY outcome
Timeframe: Two MRI examinations with an interval of 3-14 days between themPopulation: Extended Full Analysis Set (Extended-FAS): All randomized subjects who had CE-MRI/MRA image sets that qualify for blinded reads and had both gadoquatrane and SoC comparator combined pre- and post- contrast image sets assessable. The Extended-FAS comprises 378 participants. While cases lacking a definitive cSoT diagnosis for either the SoC or Gadoquatrane were excluded from this assessment, it should be noted that these participants remain eligible for inclusion in the primary analysis population
Specificity for the detection of lesions was evaluated by blinded independent central review (BICR) readers using combined pre- and post-contrast MRI image sets for gadoquatrane and comparator macrocyclic GBCAs. A lesion was defined as a localized, clinically relevant pathological change in a tissue due to injury or disease. In the context of imaging, it was defined as the localization of a pathology which might have been visualized on the MRI. The result from the BICR was then matched with the information from the composite Standard of Truth (cSoT). The cSoT was determined up to 4 weeks after second study related MRI based on the totality of the available clinical information by the referring physician.
Outcome measures
| Measure |
Gadoquatrane
n=378 Participants
Participants received gadoquatrane 0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
SoC GBCAs
n=378 Participants
Participants received an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
SoC GBCAs
Participants received an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
Pre-SoC GBCAs
Participants had an MRI image scan prior to the injection of an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol).
|
|---|---|---|---|---|
|
Specificity for the Detection of Lesions of Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs, by a BICR
Reader 1
|
47.37 % specificity
Interval 34.41 to 60.33
|
43.86 % specificity
Interval 30.98 to 56.74
|
—
|
—
|
|
Specificity for the Detection of Lesions of Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs, by a BICR
Reader 2
|
45.61 % specificity
Interval 32.68 to 58.54
|
45.61 % specificity
Interval 32.68 to 58.54
|
—
|
—
|
|
Specificity for the Detection of Lesions of Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs, by a BICR
Reader 3
|
43.86 % specificity
Interval 30.98 to 56.74
|
49.12 % specificity
Interval 36.14 to 62.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Two MRI examinations with an interval of 3-14 days between themPopulation: Full Analysis Set 2 (FAS2): All randomized participants who have: (i) CE-MRI image sets that qualify for blinded reads; (ii) have both gadoquatrane and SoC comparator combined pre- and post- contrast image sets assessable; and (iii) at least one matching lesion for at least one central reader.
Overall diagnostic clinical value is based on the three descriptive imaging features; enhancement location, extension and pattern and is measured on a 5 point scale: 1- no diagnostic clinical value; 2-poor diagnostic clinical value; 3- moderate diagnostic clinical value; 4- good diagnostic clinical value; 5-excellent diagnostic clinical value. BICR = Blinded independent central reviewer.
Outcome measures
| Measure |
Gadoquatrane
n=309 Participants
Participants received gadoquatrane 0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
SoC GBCAs
n=309 Participants
Participants received an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
SoC GBCAs
Participants received an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
Pre-SoC GBCAs
Participants had an MRI image scan prior to the injection of an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol).
|
|---|---|---|---|---|
|
The Overall Diagnostic Clinical Value of Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs
Reader 3 (BICR)
|
4.592 Score
Standard Deviation 0.869
|
4.505 Score
Standard Deviation 1.005
|
—
|
—
|
|
The Overall Diagnostic Clinical Value of Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs
Reader 1 (BICR)
|
4.874 Score
Standard Deviation 0.503
|
4.838 Score
Standard Deviation 0.575
|
—
|
—
|
|
The Overall Diagnostic Clinical Value of Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs
Reader 2 (BICR)
|
4.786 Score
Standard Deviation 0.639
|
4.812 Score
Standard Deviation 0.622
|
—
|
—
|
|
The Overall Diagnostic Clinical Value of Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs
Average local reader
|
4.489 Score
Standard Deviation 0.767
|
4.460 Score
Standard Deviation 0.791
|
—
|
—
|
SECONDARY outcome
Timeframe: Two MRI examinations with an interval of 3-14 days between themPopulation: Full Analysis Set 2 (FAS2): All randomized participants who have: (i) CE-MRI image sets that qualify for blinded reads; (ii) have both gadoquatrane and SoC comparator combined pre- and post- contrast image sets assessable; and (iii) at least one matching lesion for at least one central reader. The FAS2 comprises 309 participants. When no cSoT diagnosis existed for SoC or Gadoquatrane, these cases were excluded. However, these participants remain eligible for inclusion in the analysis population.
Sensitivity for the detection of malignant lesions was evaluated by blinded independent central review (BICR) readers and by the investigator/designee using combined pre- and post-contrast MRI image sets for gadoquatrane and comparator macrocyclic GBCAs. Lesion assessments were compared with the composite Standard of Truth (cSoT), and sensitivity with corresponding 95% confidence intervals was calculated.
Outcome measures
| Measure |
Gadoquatrane
n=309 Participants
Participants received gadoquatrane 0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
SoC GBCAs
n=309 Participants
Participants received an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
SoC GBCAs
Participants received an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
Pre-SoC GBCAs
Participants had an MRI image scan prior to the injection of an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol).
|
|---|---|---|---|---|
|
Sensitivity for the Detection of Malignant Lesions of Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs Assessed by BICR and the Investigator
Reader 1
|
85.88 % sensitivity
Interval 78.48 to 93.28
|
88.24 % sensitivity
Interval 81.39 to 95.08
|
—
|
—
|
|
Sensitivity for the Detection of Malignant Lesions of Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs Assessed by BICR and the Investigator
Reader 2
|
81.18 % sensitivity
Interval 72.87 to 89.49
|
81.18 % sensitivity
Interval 72.87 to 89.49
|
—
|
—
|
|
Sensitivity for the Detection of Malignant Lesions of Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs Assessed by BICR and the Investigator
Reader 3
|
87.06 % sensitivity
Interval 79.92 to 94.19
|
88.24 % sensitivity
Interval 81.39 to 95.08
|
—
|
—
|
SECONDARY outcome
Timeframe: Two MRI examinations with an interval of 3-14 days between themPopulation: Full Analysis Set 2 (FAS2): All randomized participants who have: (i) CE-MRI image sets that qualify for blinded reads; (ii) have both gadoquatrane and SoC comparator combined pre- and post- contrast image sets assessable; and (iii) at least one matching lesion for at least one central reader. The FAS2 comprises 309 participants. When no cSoT diagnosis existed for SoC or Gadoquatrane, these cases were excluded. However, these participants remain eligible for inclusion in the analysis population.
Specificity for the detection of malignant lesions was evaluated by blinded independent central review (BICR) readers and by the investigator/designee using combined pre- and post-contrast MRI image sets for gadoquatrane and comparator macrocyclic GBCAs. Lesion assessments were compared with the composite Standard of Truth (cSoT), and specificity with corresponding 95% confidence intervals was calculated.
Outcome measures
| Measure |
Gadoquatrane
n=309 Participants
Participants received gadoquatrane 0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
SoC GBCAs
n=309 Participants
Participants received an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
SoC GBCAs
Participants received an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
Pre-SoC GBCAs
Participants had an MRI image scan prior to the injection of an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol).
|
|---|---|---|---|---|
|
Specificity for the Detection of Malignant Lesions of Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs Assessed by BICR and the Investigator
Reader 1
|
56.52 % specificity
Interval 48.25 to 64.79
|
63.04 % specificity
Interval 54.99 to 71.1
|
—
|
—
|
|
Specificity for the Detection of Malignant Lesions of Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs Assessed by BICR and the Investigator
Reader 2
|
77.12 % specificity
Interval 70.47 to 83.78
|
79.08 % specificity
Interval 72.64 to 85.53
|
—
|
—
|
|
Specificity for the Detection of Malignant Lesions of Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs Assessed by BICR and the Investigator
Reader 3
|
46.90 % specificity
Interval 38.77 to 55.02
|
53.10 % specificity
Interval 44.98 to 61.23
|
—
|
—
|
SECONDARY outcome
Timeframe: Two MRI examinations with an interval of 3-14 days between themPopulation: Full Analysis Set 2 (FAS2): All randomized participants who have: (i) CE-MRI image sets that qualify for blinded reads; (ii) have both gadoquatrane and SoC comparator combined pre- and post- contrast image sets assessable; and (iii) at least one matching lesion for at least one central reader. FAS2 = 309 participants. When no local reader diagnosis existed for SoC or Gadoquatrane, these cases were excluded. However, these participants remain eligible for inclusion in the analysis population.
The investigator or designee, who remained blinded to the contrast agent used in the image set, was asked for the diagnosis based on the combined pre- and post-contrast MRI image sets for each period, which was compared to the composite Standard of Truth (cSoT). The cSoT was determined up to 4 weeks after second study related MRI based on the totality of the available clinical information by the referring physician. Concordance between the MRI-based diagnosis and the final clinical diagnosis was evaluated, and the number of cases with matching and non-matching diagnoses was summarized.
Outcome measures
| Measure |
Gadoquatrane
n=309 Participants
Participants received gadoquatrane 0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
SoC GBCAs
n=309 Participants
Participants received an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
SoC GBCAs
Participants received an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
Pre-SoC GBCAs
Participants had an MRI image scan prior to the injection of an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol).
|
|---|---|---|---|---|
|
Number of Cases With Concordance Between Final Diagnosis and MRI Diagnosis From Combined pre-and Post- Gadoquatrane MRI and Combined Pre- and Post- Comparator MRI With Macrocyclic GBCAs, as Assessed by the Investigator
MRI diagnoses match: Yes
|
235 Cases
|
238 Cases
|
—
|
—
|
|
Number of Cases With Concordance Between Final Diagnosis and MRI Diagnosis From Combined pre-and Post- Gadoquatrane MRI and Combined Pre- and Post- Comparator MRI With Macrocyclic GBCAs, as Assessed by the Investigator
MRI diagnoses match: No
|
30 Cases
|
29 Cases
|
—
|
—
|
SECONDARY outcome
Timeframe: Two MRI examinations with an interval of 3-14 days between themPopulation: Full Analysis Set 2 (FAS2): All randomized participants who have: (i) CE-MRI image sets that qualify for blinded reads; (ii) have both gadoquatrane and SoC comparator combined pre- and post- contrast image sets assessable; and (iii) at least one matching lesion for at least one central reader.
Confidence in diagnosis was assessed by blinded independent central review (BICR) readers and the investigator to determine the level of certainty in the assigned diagnosis based on combined pre- and post-contrast MRI image sets for gadoquatrane and comparator macrocyclic GBCAs. Confidence was scored using a 4-point scale (1 = Not confident, 2 = Somewhat confident, 3 = Confident, 4 = Very confident), and mean scores with standard deviation are reported.
Outcome measures
| Measure |
Gadoquatrane
n=309 Participants
Participants received gadoquatrane 0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
SoC GBCAs
n=309 Participants
Participants received an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
SoC GBCAs
Participants received an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
Pre-SoC GBCAs
Participants had an MRI image scan prior to the injection of an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol).
|
|---|---|---|---|---|
|
Confidence in Diagnosis Combined Pre- and Post- Gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs by BICR and by Investigator
Reader 1
|
3.249 Score
Standard Deviation 0.569
|
3.236 Score
Standard Deviation 0.569
|
—
|
—
|
|
Confidence in Diagnosis Combined Pre- and Post- Gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs by BICR and by Investigator
Reader 2
|
3.767 Score
Standard Deviation 0.526
|
3.748 Score
Standard Deviation 0.535
|
—
|
—
|
|
Confidence in Diagnosis Combined Pre- and Post- Gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs by BICR and by Investigator
Reader 3
|
3.042 Score
Standard Deviation 0.753
|
3.058 Score
Standard Deviation 0.766
|
—
|
—
|
|
Confidence in Diagnosis Combined Pre- and Post- Gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs by BICR and by Investigator
Average local reader (investigator)
|
3.540 Score
Standard Deviation 0.652
|
3.518 Score
Standard Deviation 0.667
|
—
|
—
|
SECONDARY outcome
Timeframe: Two MRI examinations with an interval of 3-14 days between themPopulation: Extended Full Analysis Set (Extended-FAS): All randomized subjects who had CE-MRI/MRA image sets that qualify for blinded reads and had both gadoquatrane and SoC comparator combined pre-and post- contrast image sets assessable.
Total number of lesions across all participants was counted by 3 blinded independent central readers on the unenhanced (pre-contrast) and combined pre- and post-contrast gadoquatrane and comparator MR image set.
Outcome measures
| Measure |
Gadoquatrane
n=378 Participants
Participants received gadoquatrane 0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
SoC GBCAs
n=378 Participants
Participants received an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
SoC GBCAs
n=378 Participants
Participants received an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
Pre-SoC GBCAs
n=378 Participants
Participants had an MRI image scan prior to the injection of an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol).
|
|---|---|---|---|---|
|
Number of Lesions Seen on Unenhanced MR Image Sets and Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs, by a BICR
Reader 3
|
783 Number of lesions
|
667 Number of lesions
|
817 Number of lesions
|
635 Number of lesions
|
|
Number of Lesions Seen on Unenhanced MR Image Sets and Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs, by a BICR
Reader 2
|
2095 Number of lesions
|
1898 Number of lesions
|
2123 Number of lesions
|
1964 Number of lesions
|
|
Number of Lesions Seen on Unenhanced MR Image Sets and Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs, by a BICR
Reader 1
|
857 Number of lesions
|
609 Number of lesions
|
763 Number of lesions
|
654 Number of lesions
|
SECONDARY outcome
Timeframe: Two MRI examinations with an interval of 3-14 days between themPopulation: Extended Full Analysis Set (Extended-FAS): All randomized subjects who had CE-MRI/MRA image sets that qualify for blinded reads and had both gadoquatrane and SoC comparator combined pre- and post-contrast image sets assessable. Only participants with enhancing lesions are considered: for gadoquatrane, 305 participants, and for SoC GBCAs 314 participants showed enhancing lesions.
The total number of contrast-enhanced lesions for each contrast- enhanced image set (gadoquatrane and comparators-enhanced MR images) was evaluated by two of the blinded independent central readers.
Outcome measures
| Measure |
Gadoquatrane
n=305 Participants
Participants received gadoquatrane 0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
SoC GBCAs
n=314 Participants
Participants received an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
SoC GBCAs
Participants received an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
Pre-SoC GBCAs
Participants had an MRI image scan prior to the injection of an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol).
|
|---|---|---|---|---|
|
Number of Enhancing Lesions Seen on Combined Pre- and Post- Gadoquatrane MRI and Combined pre-and Post-comparator MRI With Macrocyclic GBCAs, by a BICR
Reader 1
|
708 Number of enhancing lesions
|
628 Number of enhancing lesions
|
—
|
—
|
|
Number of Enhancing Lesions Seen on Combined Pre- and Post- Gadoquatrane MRI and Combined pre-and Post-comparator MRI With Macrocyclic GBCAs, by a BICR
Reader 2
|
1525 Number of enhancing lesions
|
1475 Number of enhancing lesions
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 24 ± 4 hours after administration of gadoquatrane or any approved macrocyclic GBCAsPopulation: Safety Analysis Set (SAF): All randomized subjects who have received any amount of either gadoquatrane or a comparator (SoC macrocyclic GBCA).
Treatment-emergent adverse events (TEAEs), including serious adverse events (TESAEs), are defined as events occurring from the start of study intervention until follow-up (24 ± 4 hours post-injection.
Outcome measures
| Measure |
Gadoquatrane
n=398 Participants
Participants received gadoquatrane 0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
SoC GBCAs
n=400 Participants
Participants received an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
SoC GBCAs
Participants received an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
Pre-SoC GBCAs
Participants had an MRI image scan prior to the injection of an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol).
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events, Including Number of Serious Adverse Events, After Administration of Gadoquatrane Compared to Macrocyclic GBCAs Reported by the Investigator
Any TESAE
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events, Including Number of Serious Adverse Events, After Administration of Gadoquatrane Compared to Macrocyclic GBCAs Reported by the Investigator
Any TEAE
|
52 Participants
|
52 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 24 ± 4 hours after administration of gadoquatrane or any approved macrocyclic GBCAsPopulation: Safety Analysis Set (SAF): All randomized subjects who have received any amount of either gadoquatrane or a comparator (SoC macrocyclic GBCA). Only participants with at least one treatment-emergent adverse event were included and were categorized according to the maximum intensity of any TEAE experienced (mild, moderate or severe), as assessed by the investigator.
Treatment-emergent (serious) AEs are defined as events occurring from the start of study intervention until follow-up (24 ± 4 hours post-injection). Participants with at least one treatment-emergent adverse event are counted once and categorized according to the maximum intensity of their adverse events (mild, moderate, or severe), as assessed by the investigator.
Outcome measures
| Measure |
Gadoquatrane
n=52 Participants
Participants received gadoquatrane 0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
SoC GBCAs
n=52 Participants
Participants received an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
SoC GBCAs
Participants received an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
Pre-SoC GBCAs
Participants had an MRI image scan prior to the injection of an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol).
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events, Including Number of Serious Adverse Events, Per Intensity After Administration of Gadoquatrane Compared to Macrocyclic GBCAs Reported by the Investigator
Maximum intensity for any TEAE: Mild
|
47 Participants
|
42 Participants
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events, Including Number of Serious Adverse Events, Per Intensity After Administration of Gadoquatrane Compared to Macrocyclic GBCAs Reported by the Investigator
Maximum intensity for any TEAE: Moderate
|
5 Participants
|
9 Participants
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events, Including Number of Serious Adverse Events, Per Intensity After Administration of Gadoquatrane Compared to Macrocyclic GBCAs Reported by the Investigator
Maximum intensity for any TEAE: Severe
|
0 Participants
|
1 Participants
|
—
|
—
|
Adverse Events
Gadoquatrane
Serious events: 0 serious events
Other events: 52 other events
Deaths: 0 deaths
SoC GBCAs
Serious events: 1 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gadoquatrane
n=398 participants at risk
Participants received gadoquatrane 0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose
|
SoC GBCAs
n=400 participants at risk
Participants received an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
|---|---|---|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/398 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.25%
1/400 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
Other adverse events
| Measure |
Gadoquatrane
n=398 participants at risk
Participants received gadoquatrane 0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose
|
SoC GBCAs
n=400 participants at risk
Participants received an approved standard of care macrocyclic gadolinium-based contrast agent (GBCA) (gadobutrol, gadoterate meglumine/gadoteric acid or gadoteridol), 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose.
|
|---|---|---|
|
Psychiatric disorders
Anxiety
|
0.25%
1/398 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.00%
0/400 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Vascular disorders
Phlebitis
|
0.00%
0/398 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.25%
1/400 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.25%
1/398 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.00%
0/400 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Blood and lymphatic system disorders
Monocytosis
|
0.25%
1/398 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.00%
0/400 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/398 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.25%
1/400 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/398 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.25%
1/400 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/398 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.25%
1/400 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Ear and labyrinth disorders
Vertigo
|
0.25%
1/398 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.00%
0/400 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.25%
1/398 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.00%
0/400 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Eye disorders
Cataract
|
0.00%
0/398 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.25%
1/400 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/398 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.25%
1/400 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Eye disorders
Swelling of eyelid
|
0.00%
0/398 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.25%
1/400 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Gastrointestinal disorders
Abdominal rigidity
|
0.00%
0/398 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.25%
1/400 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Gastrointestinal disorders
Dry mouth
|
0.25%
1/398 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.00%
0/400 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Gastrointestinal disorders
Nausea
|
1.3%
5/398 • Number of events 5 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
2.0%
8/400 • Number of events 9 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Gastrointestinal disorders
Vomiting
|
0.50%
2/398 • Number of events 2 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.00%
0/400 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
General disorders and administration site conditions
Asthenia
|
0.00%
0/398 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.25%
1/400 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
General disorders and administration site conditions
Chest discomfort
|
0.25%
1/398 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.00%
0/400 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
General disorders and administration site conditions
Discomfort
|
0.00%
0/398 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.25%
1/400 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
General disorders and administration site conditions
Feeling abnormal
|
0.25%
1/398 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.00%
0/400 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
General disorders and administration site conditions
Feeling hot
|
0.25%
1/398 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.00%
0/400 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
General disorders and administration site conditions
Injection site bruising
|
0.25%
1/398 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.25%
1/400 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
General disorders and administration site conditions
Injection site erythema
|
0.25%
1/398 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.00%
0/400 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
General disorders and administration site conditions
Injection site haematoma
|
0.25%
1/398 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.00%
0/400 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
General disorders and administration site conditions
Injection site pain
|
0.25%
1/398 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.25%
1/400 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
General disorders and administration site conditions
Pyrexia
|
0.00%
0/398 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.50%
2/400 • Number of events 2 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
General disorders and administration site conditions
Thirst
|
0.00%
0/398 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.25%
1/400 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
General disorders and administration site conditions
Catheter site pain
|
0.25%
1/398 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.25%
1/400 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
General disorders and administration site conditions
Catheter site haematoma
|
0.50%
2/398 • Number of events 2 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.00%
0/400 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
General disorders and administration site conditions
Catheter site oedema
|
0.25%
1/398 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.00%
0/400 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
General disorders and administration site conditions
Vessel puncture site bruise
|
0.50%
2/398 • Number of events 2 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.00%
0/400 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
General disorders and administration site conditions
Vessel puncture site haematoma
|
0.25%
1/398 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.25%
1/400 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
General disorders and administration site conditions
Vessel puncture site pain
|
0.25%
1/398 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.00%
0/400 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
General disorders and administration site conditions
Vessel puncture site erythema
|
0.00%
0/398 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.25%
1/400 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
General disorders and administration site conditions
Medical device site erythema
|
0.25%
1/398 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.00%
0/400 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
General disorders and administration site conditions
Medical device site irritation
|
0.25%
1/398 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.00%
0/400 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
General disorders and administration site conditions
Medical device site rash
|
0.00%
0/398 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.25%
1/400 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Infections and infestations
Acute sinusitis
|
0.25%
1/398 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.00%
0/400 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/398 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.25%
1/400 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/398 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.25%
1/400 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Infections and infestations
Rhinitis
|
0.00%
0/398 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.25%
1/400 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Infections and infestations
Urethritis
|
0.25%
1/398 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.25%
1/400 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Infections and infestations
Urinary tract infection
|
0.25%
1/398 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.00%
0/400 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.50%
2/398 • Number of events 2 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.25%
1/400 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/398 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.25%
1/400 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Injury, poisoning and procedural complications
Vascular access site bruising
|
0.00%
0/398 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.25%
1/400 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Investigations
Glomerular filtration rate decreased
|
0.25%
1/398 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.00%
0/400 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Investigations
White blood cells urine positive
|
0.25%
1/398 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.00%
0/400 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Investigations
Urinary sediment present
|
0.25%
1/398 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.00%
0/400 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.25%
1/398 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.00%
0/400 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/398 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.25%
1/400 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.25%
1/398 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.00%
0/400 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
0.25%
1/398 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.00%
0/400 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Nervous system disorders
Dizziness
|
1.3%
5/398 • Number of events 5 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
1.5%
6/400 • Number of events 6 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/398 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.25%
1/400 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Nervous system disorders
Headache
|
3.3%
13/398 • Number of events 14 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
3.0%
12/400 • Number of events 12 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/398 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.25%
1/400 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/398 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.25%
1/400 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/398 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.50%
2/400 • Number of events 2 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Renal and urinary disorders
Haematuria
|
0.25%
1/398 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.00%
0/400 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.50%
2/398 • Number of events 2 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.00%
0/400 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.25%
1/398 • Number of events 2 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.00%
0/400 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/398 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.25%
1/400 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.25%
1/398 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.25%
1/400 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.25%
1/398 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.00%
0/400 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.25%
1/398 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.00%
0/400 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.25%
1/398 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.50%
2/400 • Number of events 2 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/398 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.25%
1/400 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/398 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.50%
2/400 • Number of events 2 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.25%
1/398 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.00%
0/400 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/398 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.25%
1/400 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.25%
1/398 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.25%
1/400 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Vascular disorders
Haematoma
|
0.50%
2/398 • Number of events 2 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.25%
1/400 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Vascular disorders
Hypertension
|
0.00%
0/398 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.50%
2/400 • Number of events 2 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
|
Vascular disorders
Hypotension
|
0.25%
1/398 • Number of events 1 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
0.00%
0/400 • Adverse events (AEs) were collected when they started or worsened within 24 ± 4 hours after administration of the study intervention. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact (24 ± 4 hours post last injection). No deaths (all-cause mortality) were reported in the study.
Treatment-emergent adverse events (TEAEs)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All data in this study are the sole property of Bayer and may be disclosed only by Bayer to other investigators, or regulatory authorities. Written consent must be obtained from Bayer prior to any information being submitted for publication. Material proposed for publication or presentation must be provided to Bayer at least 60 days prior to submission.
- Publication restrictions are in place
Restriction type: OTHER