Trial Outcomes & Findings for Open Label, Randomized Study of Low Concentration Ioforminol Injections for Use in Abdominal CECT in Healthy Volunteers (NCT NCT01672996)
NCT ID: NCT01672996
Last Updated: 2014-05-29
Results Overview
Quantitative measurement of the radiographic density (as measured by Hounsfield Units (HU) ) at the abdominal aorta at the level of the celiac artery. The greater the contrast attenuation, the higher the HU.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
66 participants
Primary outcome timeframe
Within 5 minutes after administration for either Ioforminol or Iopamidol.
Results posted on
2014-05-29
Participant Flow
Participant milestones
| Measure |
Arm 1 - Ioforminol 160mgI/mL
Single administration of Ioforminol 160mgI/mL given to the subject.
Ioforminol 160 mgI/mL: Given as s single administration to the subject
|
Arm 2 - Ioforminol 200mgI/mL
Given as a single administration to the subject
Ioforminol 200 mgI/mL: Given as a single administration to the subject
|
Arm 3 - Iopamidol 300mgI/mL
Given as a single administration to the subject
Iopamidol 300 mgI/mL: Given as a single administration to the subject
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
6
|
|
Overall Study
COMPLETED
|
30
|
30
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Open Label, Randomized Study of Low Concentration Ioforminol Injections for Use in Abdominal CECT in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg
n=10 Participants
Ioforminol 160 mgI/mL: Given as s single administration to the subject.
Dosing the Subject at 1.0mL/kg.
|
Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg
n=10 Participants
Ioforminol 160 mgI/mL: Given as s single administration to the subject.
Dosing the Subject at 1.5mL/kg.
|
Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg
n=10 Participants
Ioforminol 160 mgI/mL: Given as s single administration to the subject.
Dosing the Subject at 2.0mL/kg.
|
Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg
n=10 Participants
Ioforminol 200 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 1.0mL/Kg
|
Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg
n=10 Participants
Ioforminol 200 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 1.5mL/Kg
|
Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg
n=10 Participants
Ioforminol 200 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 2.0mL/Kg
|
Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg
n=6 Participants
Iopamidol 300 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 1.0mL/Kg
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
66 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
35 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
31 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
66 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Within 5 minutes after administration for either Ioforminol or Iopamidol.Population: Evaluted 33 subjects using 80 kilovolt peak (kVp), a measure of the maximum electrical potential in kilovolts across an x-ray.
Quantitative measurement of the radiographic density (as measured by Hounsfield Units (HU) ) at the abdominal aorta at the level of the celiac artery. The greater the contrast attenuation, the higher the HU.
Outcome measures
| Measure |
Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg
n=5 Participants
Ioforminol 160 mgI/mL: Given as s single administration to the subject.
Dosing the Subject at 1.0mL/kg.
|
Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg
n=5 Participants
Ioforminol 160 mgI/mL: Given as s single administration to the subject.
Dosing the Subject at 1.5mL/kg.
|
Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg
n=5 Participants
Ioforminol 160 mgI/mL: Given as s single administration to the subject.
Dosing the Subject at 2.0mL/kg.
|
Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg
n=5 Participants
Ioforminol 200 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 1.0mL/Kg
|
Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg
n=5 Participants
Ioforminol 200 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 1.5mL/Kg
|
Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg
n=5 Participants
Ioforminol 200 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 2.0mL/Kg
|
Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg
n=3 Participants
Iopamidol 300 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 1.0mL/Kg
|
|---|---|---|---|---|---|---|---|
|
Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 80 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg).
|
168 Hounsfield Units
Standard Deviation 41.0
|
261 Hounsfield Units
Standard Deviation 56.5
|
345 Hounsfield Units
Standard Deviation 30.7
|
341 Hounsfield Units
Standard Deviation 33.6
|
357 Hounsfield Units
Standard Deviation 30.1
|
365 Hounsfield Units
Standard Deviation 67.7
|
331 Hounsfield Units
Standard Deviation 53.7
|
PRIMARY outcome
Timeframe: Within 5 minutes after administration for either Ioforminol or Iopamidol.Population: Evaluted 33 subjects using 100 kilovolt peak (kVp), a measure of the maximum electrical potential in kilovolts across an x-ray. tube.
Quantitative measurement of the radiographic density (as measured by Hounsfield Units (HU) ) at the abdominal aorta at the level of the celiac artery. The greater the contrast attenuation, the higher the HU.
Outcome measures
| Measure |
Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg
n=5 Participants
Ioforminol 160 mgI/mL: Given as s single administration to the subject.
Dosing the Subject at 1.0mL/kg.
|
Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg
n=5 Participants
Ioforminol 160 mgI/mL: Given as s single administration to the subject.
Dosing the Subject at 1.5mL/kg.
|
Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg
n=5 Participants
Ioforminol 160 mgI/mL: Given as s single administration to the subject.
Dosing the Subject at 2.0mL/kg.
|
Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg
n=5 Participants
Ioforminol 200 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 1.0mL/Kg
|
Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg
n=5 Participants
Ioforminol 200 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 1.5mL/Kg
|
Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg
n=5 Participants
Ioforminol 200 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 2.0mL/Kg
|
Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg
n=3 Participants
Iopamidol 300 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 1.0mL/Kg
|
|---|---|---|---|---|---|---|---|
|
Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 100 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg).
|
191 Hounsfield Units
Standard Deviation 34.6
|
230 Hounsfield Units
Standard Deviation 40.2
|
212 Hounsfield Units
Standard Deviation 22.2
|
261 Hounsfield Units
Standard Deviation 37.7
|
246 Hounsfield Units
Standard Deviation 36.6
|
240 Hounsfield Units
Standard Deviation 49.4
|
257 Hounsfield Units
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: Up to 72 hours for safety monitoring post Ioforminol and Iopamidol administration.Population: These are the numbers of Treatment Emergent Adverse Events (TEAE) and TEAEs related to Investigational Medicinal Product (IMP).
Recording the occurrence of treatment emergent adverse events (TEAE).
Outcome measures
| Measure |
Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg
n=10 Participants
Ioforminol 160 mgI/mL: Given as s single administration to the subject.
Dosing the Subject at 1.0mL/kg.
|
Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg
n=10 Participants
Ioforminol 160 mgI/mL: Given as s single administration to the subject.
Dosing the Subject at 1.5mL/kg.
|
Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg
n=10 Participants
Ioforminol 160 mgI/mL: Given as s single administration to the subject.
Dosing the Subject at 2.0mL/kg.
|
Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg
n=10 Participants
Ioforminol 200 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 1.0mL/Kg
|
Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg
n=10 Participants
Ioforminol 200 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 1.5mL/Kg
|
Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg
n=10 Participants
Ioforminol 200 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 2.0mL/Kg
|
Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg
n=6 Participants
Iopamidol 300 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 1.0mL/Kg
|
|---|---|---|---|---|---|---|---|
|
Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE).
Any Treatment Emergent Adverse Events (TEAE)
|
3 Adverse Events
|
5 Adverse Events
|
13 Adverse Events
|
8 Adverse Events
|
5 Adverse Events
|
7 Adverse Events
|
5 Adverse Events
|
|
Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE).
Any Treatment Emergent Adverse Events-IMP
|
2 Adverse Events
|
5 Adverse Events
|
13 Adverse Events
|
8 Adverse Events
|
5 Adverse Events
|
7 Adverse Events
|
5 Adverse Events
|
|
Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE).
Intensity-Mild
|
3 Adverse Events
|
5 Adverse Events
|
13 Adverse Events
|
8 Adverse Events
|
5 Adverse Events
|
7 Adverse Events
|
5 Adverse Events
|
|
Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE).
Serious TEAEs
|
0 Adverse Events
|
0 Adverse Events
|
0 Adverse Events
|
0 Adverse Events
|
0 Adverse Events
|
0 Adverse Events
|
0 Adverse Events
|
|
Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE).
Withdrawals due to Adverse Events
|
0 Adverse Events
|
0 Adverse Events
|
0 Adverse Events
|
0 Adverse Events
|
0 Adverse Events
|
0 Adverse Events
|
0 Adverse Events
|
|
Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE).
Deaths
|
0 Adverse Events
|
0 Adverse Events
|
0 Adverse Events
|
0 Adverse Events
|
0 Adverse Events
|
0 Adverse Events
|
0 Adverse Events
|
Adverse Events
Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg
n=10 participants at risk
Ioforminol 160 mgI/mL: Given as s single administration to the subject.
Dosing the Subject at 1.0mL/kg.
|
Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg
n=10 participants at risk
Ioforminol 160 mgI/mL: Given as s single administration to the subject.
Dosing the Subject at 1.5mL/kg.
|
Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg
n=10 participants at risk
Ioforminol 160 mgI/mL: Given as s single administration to the subject.
Dosing the Subject at 2.0mL/kg.
|
Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg
n=10 participants at risk
Ioforminol 200 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 1.0mL/Kg
|
Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg
n=10 participants at risk
Ioforminol 200 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 1.5mL/Kg
|
Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg
n=10 participants at risk
Ioforminol 200 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 2.0mL/Kg
|
Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg
n=6 participants at risk
Iopamidol 300 mgI/mL: Given as a single administration to the subject.
Dosing the Subject at 1.0mL/Kg
|
|---|---|---|---|---|---|---|---|
|
General disorders
Nausea
|
10.0%
1/10 • Number of events 1 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/6 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
|
General disorders
Feeling Hot
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
10.0%
1/10 • Number of events 1 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
20.0%
2/10 • Number of events 2 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
10.0%
1/10 • Number of events 1 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
20.0%
2/10 • Number of events 2 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
10.0%
1/10 • Number of events 1 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
83.3%
5/6 • Number of events 5 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
10.0%
1/10 • Number of events 1 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/6 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
10.0%
1/10 • Number of events 1 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/6 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
|
Nervous system disorders
Dysgeusia
|
10.0%
1/10 • Number of events 1 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
50.0%
5/10 • Number of events 5 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
90.0%
9/10 • Number of events 9 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
70.0%
7/10 • Number of events 7 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
50.0%
5/10 • Number of events 5 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
50.0%
5/10 • Number of events 5 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
33.3%
2/6 • Number of events 2 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
10.0%
1/10 • Number of events 1 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
10.0%
1/10 • Number of events 1 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
16.7%
1/6 • Number of events 1 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
10.0%
1/10 • Number of events 1 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/6 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
10.0%
1/10 • Number of events 1 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/6 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
10.0%
1/10 • Number of events 1 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/6 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/10 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
20.0%
2/10 • Number of events 2 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
0.00%
0/6 • Up to 72 hours post Ioforminal or Iopamidol administration.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place