Trial Outcomes & Findings for Ultravist: Safety and Efficacy in Computed Tomography of Head and Body (NCT NCT00244140)

Last Updated: 2014-02-28

Results Overview

A subjective assessment of the 'Quality of Image' (QOI) by 3 blinded readers (BR). QOI-Grades used: Excellent - Good - Poor.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

435 participants

Primary outcome timeframe

post administration assessment of study images

Results posted on

2014-02-28

Participant Flow

The recruitment period was 21 Oct 2005 to 11 Apr 2008.

437 subjects were screened; 2 subjects were screen failures because of not meeting inclusion criteria and/or meeting exclusion criteria; 435 subjects were enrolled; 1 enrolled subject withdrew consent before receiving study drug; 434 subjects received study drug and were included in the safety analysis set.

Participant milestones

Participant milestones
Measure	Iopromide 370 mg I/mL Iopromide (Ultravist 370 mg I/mL) administered intravenously	Iopromide 300 mg I/mL Iopromide (Ultravist 300 mg I/mL) administered intravenously
Overall Study STARTED	412	22
Overall Study COMPLETED	412	22
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ultravist: Safety and Efficacy in Computed Tomography of Head and Body

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Iopromide 370 mg I/mL n=412 Participants Iopromide (Ultravist 370 mg I/mL) administered intravenously	Iopromide 300 mg I/mL n=22 Participants Iopromide (Ultravist 300 mg I/mL) administered intravenously	Total n=434 Participants Total of all reporting groups
Age, Continuous	51.9 years STANDARD_DEVIATION 15.15 • n=5 Participants	56.5 years STANDARD_DEVIATION 14.54 • n=7 Participants	52.1 years STANDARD_DEVIATION 15.13 • n=5 Participants
Sex: Female, Male Female	191 Participants n=5 Participants	16 Participants n=7 Participants	207 Participants n=5 Participants
Sex: Female, Male Male	221 Participants n=5 Participants	6 Participants n=7 Participants	227 Participants n=5 Participants

PRIMARY outcome

Timeframe: post administration assessment of study images

Population: The primary efficacy analysis used the Full Analysis Set (FAS), which consisted of the subjects who received any amount of iopromide regardless of any protocol deviation, excluding the sample subjects and subjects who did not have CT images. In the FAS, 402 subjects were included.

A subjective assessment of the 'Quality of Image' (QOI) by 3 blinded readers (BR). QOI-Grades used: Excellent - Good - Poor.

Outcome measures

Outcome measures
Measure	Iopromide 370 mg I/mL n=382 Participants Iopromide (Ultravist 370 mg I/mL) administered intravenously	Iopromide 300 mg I/mL n=20 Participants Iopromide (Ultravist 300 mg I/mL) administered intravenously
The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment. Excellent + Good (blinded reader 1)	366 Number of participants in QOI grade	17 Number of participants in QOI grade
The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment. Poor (blinded reader 1)	16 Number of participants in QOI grade	3 Number of participants in QOI grade
The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment. Excellent + Good (blinded reader 2)	368 Number of participants in QOI grade	19 Number of participants in QOI grade
The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment. Poor (blinded reader 2)	14 Number of participants in QOI grade	1 Number of participants in QOI grade
The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment. Excellent + Good (blinded reader 3)	376 Number of participants in QOI grade	15 Number of participants in QOI grade
The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment. Poor (blinded reader 3)	6 Number of participants in QOI grade	5 Number of participants in QOI grade

SECONDARY outcome

Timeframe: post administration assessment of study images

The number of participants with diagnostic CECTs as assessed by the investigators.

Outcome measures

Outcome measures
Measure	Iopromide 370 mg I/mL n=382 Participants Iopromide (Ultravist 370 mg I/mL) administered intravenously	Iopromide 300 mg I/mL n=20 Participants Iopromide (Ultravist 300 mg I/mL) administered intravenously
The Ability of the Investigator to Make a Diagnosis Based on the CECT Images No	1 Number of diagnostic CECTs	0 Number of diagnostic CECTs
The Ability of the Investigator to Make a Diagnosis Based on the CECT Images Not applicable	0 Number of diagnostic CECTs	0 Number of diagnostic CECTs
The Ability of the Investigator to Make a Diagnosis Based on the CECT Images Yes	381 Number of diagnostic CECTs	20 Number of diagnostic CECTs

SECONDARY outcome

Timeframe: post administration assessment of study images

A subjective assessment of the 'Quality of Image' (QOI) by the investigators. QOI-Grades used: Excellent - Good - Poor.

Outcome measures

Outcome measures
Measure	Iopromide 370 mg I/mL n=382 Participants Iopromide (Ultravist 370 mg I/mL) administered intravenously	Iopromide 300 mg I/mL n=20 Participants Iopromide (Ultravist 300 mg I/mL) administered intravenously
The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Investigators' Assessment. Excellent + Good	380 Number of participants in QOI grade	20 Number of participants in QOI grade
The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Investigators' Assessment. Poor	2 Number of participants in QOI grade	0 Number of participants in QOI grade

SECONDARY outcome

Timeframe: post administration assessment of study images

The number of participants with diagnostic CECTs as assessed by the 3 blinded readers.

Outcome measures

Outcome measures
Measure	Iopromide 370 mg I/mL n=382 Participants Iopromide (Ultravist 370 mg I/mL) administered intravenously	Iopromide 300 mg I/mL n=20 Participants Iopromide (Ultravist 300 mg I/mL) administered intravenously
The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images No (blinded reader 2)	0 Number of diagnostic CECTs	0 Number of diagnostic CECTs
The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images No (blinded reader 1)	6 Number of diagnostic CECTs	2 Number of diagnostic CECTs
The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images Not applicable (blinded reader 1)	0 Number of diagnostic CECTs	0 Number of diagnostic CECTs
The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images Yes (blinded reader 1)	376 Number of diagnostic CECTs	18 Number of diagnostic CECTs
The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images Not applicable (blinded reader 2)	0 Number of diagnostic CECTs	0 Number of diagnostic CECTs
The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images Yes (blinded reader 2)	382 Number of diagnostic CECTs	20 Number of diagnostic CECTs
The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images No (blinded reader 3)	0 Number of diagnostic CECTs	0 Number of diagnostic CECTs
The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images Not applicable (blinded reader 3)	1 Number of diagnostic CECTs	0 Number of diagnostic CECTs
The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images Yes (blinded reader 3)	381 Number of diagnostic CECTs	20 Number of diagnostic CECTs

Adverse Events

Iopromide 370 mg I/mL

Serious events: 2 serious events

Other events: 32 other events

Deaths: 0 deaths

Iopromide 300 mg I/mL

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Iopromide 370 mg I/mL n=412 participants at risk Iopromide (Ultravist 370 mg I/mL) administered intravenously	Iopromide 300 mg I/mL n=22 participants at risk Iopromide (Ultravist 300 mg I/mL) administered intravenously
Gastrointestinal disorders Gastrointestinal disorder	0.24% 1/412	0.00% 0/22
Gastrointestinal disorders Nausea	0.24% 1/412	0.00% 0/22
Gastrointestinal disorders Vomiting	0.24% 1/412	0.00% 0/22
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.24% 1/412	0.00% 0/22
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.24% 1/412	0.00% 0/22
Vascular disorders Hypotension	0.24% 1/412	0.00% 0/22

Other adverse events

Other adverse events
Measure	Iopromide 370 mg I/mL n=412 participants at risk Iopromide (Ultravist 370 mg I/mL) administered intravenously	Iopromide 300 mg I/mL n=22 participants at risk Iopromide (Ultravist 300 mg I/mL) administered intravenously
Gastrointestinal disorders Nausea	1.5% 6/412	0.00% 0/22
Skin and subcutaneous tissue disorders Erythema	0.97% 4/412	0.00% 0/22
Skin and subcutaneous tissue disorders Urticaria	0.73% 3/412	0.00% 0/22
Nervous system disorders Dysgeusia	1.2% 5/412	0.00% 0/22
General disorders Feeling Hot	0.97% 4/412	0.00% 0/22
Gastrointestinal disorders Abdominal discomfort	0.49% 2/412	0.00% 0/22
Gastrointestinal disorders Diarrhoea	0.49% 2/412	4.5% 1/22
Gastrointestinal disorders Gastrointestinal pain	0.49% 2/412	0.00% 0/22
Nervous system disorders Headache	0.49% 2/412	0.00% 0/22
Investigations Haemoglobin increased	0.49% 2/412	0.00% 0/22
Investigations White blood cell count increased	0.49% 2/412	0.00% 0/22
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.49% 2/412	0.00% 0/22

Additional Information

Therapeutic Area Head

BAYER

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60