Trial Outcomes & Findings for Efficacy and Safety of Primovist in Chinese Patients (NCT NCT00526188)
NCT ID: NCT00526188
Last Updated: 2015-05-01
Results Overview
Three Blinded Readers performed lesion detection in pre- and post-contrast MRI image sets. Per Blinded Reader/image set combination, sensitivity of lesion detection was calculated, as: (number of lesions detected in the reader/image set combination)/(number of lesions in Standard of Reference)\*100%. Then, difference in sensitivity of lesion detection for post- minus pre-contrast MRI images (in percentage points) was calculated for each Blinded Reader.
COMPLETED
PHASE3
234 participants
Post administration assessment of study images (i.e. on the same day of treatment by the investigators and at the end of patient enrollment of the study from 29 September to 18 November 2008 by the Blinded Readers).
2015-05-01
Participant Flow
The recruitment period was 20 Aug 2007 to 30 Aug 2008.
247 Chinese patients were recruited and screened. Among these, 13 patients were screening failures: withdrawal of consent (7 patients), non-fulfillment of the inclusion and exclusion criteria (3 patients), other reasons (3 patients). The remaining 234 patients received the study drug and were included in the safety analysis set.
Participant milestones
| Measure |
Gadoxetic Acid Disodium (Primovist, BAY86-4873)
Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
|
|---|---|
|
Overall Study
STARTED
|
234
|
|
Overall Study
COMPLETED
|
234
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Primovist in Chinese Patients
Baseline characteristics by cohort
| Measure |
Gadoxetic Acid Disodium (Primovist, BAY86-4873)
n=234 Participants
Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
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|---|---|
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Age, Continuous
|
50.2 years
STANDARD_DEVIATION 11.78 • n=99 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
155 Participants
n=99 Participants
|
|
Characterization of first liver lesion type of referral diagnosis
Hepatocellular carcinoma
|
47 participants
n=99 Participants
|
|
Characterization of first liver lesion type of referral diagnosis
Cholangiocarcinoma
|
1 participants
n=99 Participants
|
|
Characterization of first liver lesion type of referral diagnosis
Metastasis
|
58 participants
n=99 Participants
|
|
Characterization of first liver lesion type of referral diagnosis
Focal nodular hyperplasia
|
14 participants
n=99 Participants
|
|
Characterization of first liver lesion type of referral diagnosis
Hemangioma
|
42 participants
n=99 Participants
|
|
Characterization of first liver lesion type of referral diagnosis
Abscess
|
2 participants
n=99 Participants
|
|
Characterization of first liver lesion type of referral diagnosis
Focal fatty infiltration
|
1 participants
n=99 Participants
|
|
Characterization of first liver lesion type of referral diagnosis
Liver cyst
|
13 participants
n=99 Participants
|
|
Characterization of first liver lesion type of referral diagnosis
Inflammation
|
1 participants
n=99 Participants
|
|
Characterization of first liver lesion type of referral diagnosis
Harmatoma
|
1 participants
n=99 Participants
|
|
Characterization of first liver lesion type of referral diagnosis
Infection
|
1 participants
n=99 Participants
|
|
Characterization of first liver lesion type of referral diagnosis
Inflammatory pseudotumor
|
2 participants
n=99 Participants
|
|
Characterization of first liver lesion type of referral diagnosis
Not assessable
|
51 participants
n=99 Participants
|
|
Characterization of second liver lesion type of referral diagnosis
No second liver lesion type
|
191 participants
n=99 Participants
|
|
Characterization of second liver lesion type of referral diagnosis
Hepatocellular carcinoma
|
3 participants
n=99 Participants
|
|
Characterization of second liver lesion type of referral diagnosis
Metastasis
|
5 participants
n=99 Participants
|
|
Characterization of second liver lesion type of referral diagnosis
Hemangioma
|
7 participants
n=99 Participants
|
|
Characterization of second liver lesion type of referral diagnosis
Hydatid cyst
|
1 participants
n=99 Participants
|
|
Characterization of second liver lesion type of referral diagnosis
Liver cyst
|
23 participants
n=99 Participants
|
|
Characterization of second liver lesion type of referral diagnosis
Calcification
|
1 participants
n=99 Participants
|
|
Characterization of second liver lesion type of referral diagnosis
Inflammatory pseudotumor
|
1 participants
n=99 Participants
|
|
Characterization of second liver lesion type of referral diagnosis
Not assessable
|
2 participants
n=99 Participants
|
|
Characterization of third liver lesion type of referral diagnosis
No third liver lesion type
|
231 participants
n=99 Participants
|
|
Characterization of third liver lesion type of referral diagnosis
Hemangioma
|
1 participants
n=99 Participants
|
|
Characterization of third liver lesion type of referral diagnosis
Liver cyst
|
1 participants
n=99 Participants
|
|
Characterization of third liver lesion type of referral diagnosis
Calcification
|
1 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Post administration assessment of study images (i.e. on the same day of treatment by the investigators and at the end of patient enrollment of the study from 29 September to 18 November 2008 by the Blinded Readers).Population: All participants from the per protocol set with pre- and post-contrast MRI image sets evaluable for all blinded readers, with at least 1 lesion in the Standard of Reference (SOR)
Three Blinded Readers performed lesion detection in pre- and post-contrast MRI image sets. Per Blinded Reader/image set combination, sensitivity of lesion detection was calculated, as: (number of lesions detected in the reader/image set combination)/(number of lesions in Standard of Reference)\*100%. Then, difference in sensitivity of lesion detection for post- minus pre-contrast MRI images (in percentage points) was calculated for each Blinded Reader.
Outcome measures
| Measure |
Gadoxetic Acid Disodium (Primovist, BAY86-4873)
n=176 Participants
Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
|
|---|---|
|
Difference in Sensitivity of Lesion Detection in MRI Images (Post-contrast MRI Minus Pre-contrast MRI) Measured as Percentage Points
BR 1: Dif. in sens. post- minus pre-contrast MRI
|
8.65 Percentage points
Interval 4.82 to 12.47
|
|
Difference in Sensitivity of Lesion Detection in MRI Images (Post-contrast MRI Minus Pre-contrast MRI) Measured as Percentage Points
BR 2: Dif. in sens. post- minus pre-contrast MRI
|
12.23 Percentage points
Interval 7.6 to 16.87
|
|
Difference in Sensitivity of Lesion Detection in MRI Images (Post-contrast MRI Minus Pre-contrast MRI) Measured as Percentage Points
BR 3: Dif. in sens. post- minus pre-contrast MRI
|
7.50 Percentage points
Interval 2.84 to 12.17
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SECONDARY outcome
Timeframe: Post administration assessment of study images (i.e. on the same day of treatment by the investigators and at the end of patient enrollment of the study from 29 September to 18 November 2008 by the Blinded Readers).Population: All participants from the per protocol set, with at least 1 lesion in the Standard of Reference (SOR).
The on-site investigators performed lesion detection in pre- and post-contrast MRI image sets. Per image set, sensitivity of lesion detection was calculated, as: (number of lesions detected in image set)/(number of lesions in Standard of Reference)\*100%. Then, difference in sensitivity of lesion detection for post- minus pre-contrast MRI (in percentage points) was calculated.
Outcome measures
| Measure |
Gadoxetic Acid Disodium (Primovist, BAY86-4873)
n=177 Participants
Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
|
|---|---|
|
Difference in Sensitivity of Lesion Detection in MRI Images (Post-contrast MRI Minus Pre-contrast MRI) Assessed by Investigators Measured in Percentage Points
|
4.81 Percentage points
Interval 1.84 to 7.78
|
SECONDARY outcome
Timeframe: Post administration assessment of study images (i.e. on the same day of treatment by the investigators and at the end of patient enrollment of the study from 29 September to 18 November 2008 by the Blinded Readers).Population: All participants from the per protocol set with pre- and combined pre- and post- contrast MRI image sets evaluable for all blinded readers, with at least 1 lesion characterization in the Standard of reference (SOR)
Three Blinded Reader performed lesion characterization in pre- and combined pre-/post-contrast MRI image set. Per Blinded Reader/image set combination, precision of lesion characterization was calculated: (number of unique Standard of Reference-matched characterizations detected for the Reader/image set combination)/(number of unique lesion characterizations in Standard of Reference)\*100%. Then, difference in precision of lesion characterization for post- minus combined pre-/post-contrast MRI (in percentage points) was calculated for each Blinded Reader.
Outcome measures
| Measure |
Gadoxetic Acid Disodium (Primovist, BAY86-4873)
n=165 Participants
Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
|
|---|---|
|
Difference in Precision of Lesion Characterization (Combined Pre- and Post-contrast Minus Pre-contrast MRI) Measured in Percentage Points
BR1: Dif. in prec. pre-/post- minus pre-contrast
|
13.64 Percentage points
Interval 7.8 to 19.47
|
|
Difference in Precision of Lesion Characterization (Combined Pre- and Post-contrast Minus Pre-contrast MRI) Measured in Percentage Points
BR2: Dif. in prec. pre-/post- minus pre-contrast
|
9.55 Percentage points
Interval 3.13 to 15.96
|
|
Difference in Precision of Lesion Characterization (Combined Pre- and Post-contrast Minus Pre-contrast MRI) Measured in Percentage Points
BR3: Dif. in prec. pre-/post- minus pre-contrast
|
10.91 Percentage points
Interval 5.32 to 16.5
|
Adverse Events
Gadoxetic Acid Disodium (Primovist, BAY86-4873)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Gadoxetic Acid Disodium (Primovist, BAY86-4873)
n=234 participants at risk
Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
|
|---|---|
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Investigations
Blood pressure systolic increased
|
0.43%
1/234
|
|
Vascular disorders
Hypertension
|
1.7%
4/234
|
|
Investigations
Blood pressure diastolic increased
|
0.43%
1/234
|
|
Vascular disorders
Hypotension
|
0.85%
2/234
|
|
Investigations
Blood lactate dehydrogenase increased
|
1.3%
3/234
|
|
Investigations
Blood glucose increased
|
0.85%
2/234
|
|
General disorders
Injection site pain
|
0.43%
1/234
|
|
Gastrointestinal disorders
Nausea
|
0.85%
2/234
|
|
Investigations
White blood cell count decreased
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0.85%
2/234
|
|
Investigations
Blood bilirubin increased
|
1.3%
3/234
|
|
Investigations
Blood phosphorus increased
|
0.43%
1/234
|
|
Investigations
Alanine aminotransferase increased
|
0.43%
1/234
|
|
Investigations
Aspartate aminotransferase increased
|
0.43%
1/234
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60