Trial Outcomes & Findings for A Phase 1b Study of IV PRM151 in Patients With Idiopathic Pulmonary Fibrosis (IPF) (NCT NCT01254409)
NCT ID: NCT01254409
Last Updated: 2022-04-20
Results Overview
Number of subjects with Dose Limiting Toxicities, Number of Treatment Emergent Serious Adverse Events and Adverse Events
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
21 participants
Primary outcome timeframe
From first dose on Day 1 through Day 57
Results posted on
2022-04-20
Participant Flow
Participant milestones
| Measure |
Placebo
0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 1 mg/kg
PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 5 mg/kg
PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 10 mg/kg
PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
5
|
4
|
|
Overall Study
COMPLETED
|
6
|
5
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo
0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 1 mg/kg
PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 5 mg/kg
PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 10 mg/kg
PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Phase 1b Study of IV PRM151 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Baseline characteristics by cohort
| Measure |
Placebo
n=6 Participants
0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 1 mg/kg
n=6 Participants
PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 5 mg/kg
n=5 Participants
PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 10 mg/kg
n=4 Participants
PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
65.5 years
STANDARD_DEVIATION 12.88 • n=39 Participants
|
63.7 years
STANDARD_DEVIATION 8.45 • n=41 Participants
|
70.6 years
STANDARD_DEVIATION 8.26 • n=35 Participants
|
66.5 years
STANDARD_DEVIATION 5.69 • n=31 Participants
|
66.4 years
STANDARD_DEVIATION 9.21 • n=146 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
4 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
17 Participants
n=146 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
20 Participants
n=146 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=39 Participants
|
1 participants
n=41 Participants
|
2 participants
n=35 Participants
|
4 participants
n=31 Participants
|
9 participants
n=146 Participants
|
|
Region of Enrollment
Netherlands
|
4 participants
n=39 Participants
|
5 participants
n=41 Participants
|
3 participants
n=35 Participants
|
0 participants
n=31 Participants
|
12 participants
n=146 Participants
|
|
FVC
|
2.15 liters
STANDARD_DEVIATION 0.64 • n=39 Participants
|
2.96 liters
STANDARD_DEVIATION 0.85 • n=41 Participants
|
2.78 liters
STANDARD_DEVIATION 0.73 • n=35 Participants
|
2.97 liters
STANDARD_DEVIATION 0.71 • n=31 Participants
|
2.67 liters
STANDARD_DEVIATION 0.76 • n=146 Participants
|
|
FVC % Predicted
|
63.2 percent
STANDARD_DEVIATION 16.7 • n=39 Participants
|
82.4 percent
STANDARD_DEVIATION 15.5 • n=41 Participants
|
80.0 percent
STANDARD_DEVIATION 7.8 • n=35 Participants
|
72.8 percent
STANDARD_DEVIATION 14.3 • n=31 Participants
|
74.1 percent
STANDARD_DEVIATION 15.3 • n=146 Participants
|
|
FEV1 % Predicted
|
68.8 percent
STANDARD_DEVIATION 17.7 • n=39 Participants
|
85.8 percent
STANDARD_DEVIATION 16.8 • n=41 Participants
|
87.0 percent
STANDARD_DEVIATION 11.9 • n=35 Participants
|
73.0 percent
STANDARD_DEVIATION 12.1 • n=31 Participants
|
78.5 percent
STANDARD_DEVIATION 16.2 • n=146 Participants
|
|
DLCO
|
35.2 percent
STANDARD_DEVIATION 8.4 • n=39 Participants
|
41.2 percent
STANDARD_DEVIATION 10.5 • n=41 Participants
|
52.8 percent
STANDARD_DEVIATION 9.8 • n=35 Participants
|
46.0 percent
STANDARD_DEVIATION 7.2 • n=31 Participants
|
43.3 percent
STANDARD_DEVIATION 10.9 • n=146 Participants
|
PRIMARY outcome
Timeframe: From first dose on Day 1 through Day 57Population: All subjects who received at least one dose of study treatment
Number of subjects with Dose Limiting Toxicities, Number of Treatment Emergent Serious Adverse Events and Adverse Events
Outcome measures
| Measure |
PRM-151 5 mg/kg
n=5 Participants
PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 10 mg/kg
n=4 Participants
PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
Placebo
n=6 Participants
0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 1 mg/kg
n=6 Participants
PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
|---|---|---|---|---|
|
Safety and Tolerability
Dose Limiting Toxicities
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety and Tolerability
Adverse Events
|
5 participants
|
4 participants
|
6 participants
|
6 participants
|
|
Safety and Tolerability
Serious Adverse Events
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 15Population: Subjects who received all doses of study treatment
Maximum concentration
Outcome measures
| Measure |
PRM-151 5 mg/kg
n=4 Participants
PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 10 mg/kg
PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
Placebo
n=5 Participants
0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 1 mg/kg
n=5 Participants
PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
|---|---|---|---|---|
|
Cmax
|
225 µg/mL
Standard Deviation 43.7
|
—
|
25.5 µg/mL
Standard Deviation 7.9
|
145 µg/mL
Standard Deviation 41.9
|
SECONDARY outcome
Timeframe: Day 15Time of Maximum observed concentration
Outcome measures
| Measure |
PRM-151 5 mg/kg
n=4 Participants
PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 10 mg/kg
PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
Placebo
n=5 Participants
0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 1 mg/kg
n=5 Participants
PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
|---|---|---|---|---|
|
Tmax
|
0.69 hours
Standard Deviation 1.25
|
—
|
5.35 hours
Standard Deviation 10.4
|
1.30 hours
Standard Deviation 1.51
|
SECONDARY outcome
Timeframe: Day 15Area under the curve from 0 to 48 hrs post dose, with samples collected at 0.5, 0.75, 1, 1.5, 2, 3,4,6,8,12,16, 24 and 48 hours post Day 15 dose.
Outcome measures
| Measure |
PRM-151 5 mg/kg
n=4 Participants
PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 10 mg/kg
PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
Placebo
n=5 Participants
0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 1 mg/kg
n=5 Participants
PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
|---|---|---|---|---|
|
AUC48
|
4710 µg*hr/mL
Standard Deviation 1180
|
—
|
446 µg*hr/mL
Standard Deviation 118
|
2190 µg*hr/mL
Standard Deviation 1140
|
SECONDARY outcome
Timeframe: Day 15Outcome measures
| Measure |
PRM-151 5 mg/kg
n=4 Participants
PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 10 mg/kg
PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
Placebo
n=5 Participants
0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 1 mg/kg
n=5 Participants
PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
|---|---|---|---|---|
|
Terminal Elimination Half Life
|
71.6 hour
Interval 32.8 to 110.0
|
—
|
21.7 hour
Interval 14.0 to 29.3
|
43.6 hour
Interval 11.2 to 79.2
|
SECONDARY outcome
Timeframe: Day 15Outcome measures
| Measure |
PRM-151 5 mg/kg
n=4 Participants
PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 10 mg/kg
PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
Placebo
n=5 Participants
0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 1 mg/kg
n=5 Participants
PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
|---|---|---|---|---|
|
Total Body Clearance
|
1.09 ml/hr/kg
Interval 0.749 to 1.42
|
—
|
2.33 ml/hr/kg
Interval 1.17 to 3.48
|
1.59 ml/hr/kg
Interval 0.78 to 2.65
|
SECONDARY outcome
Timeframe: Day 15Volume of Distribution at Steady State
Outcome measures
| Measure |
PRM-151 5 mg/kg
n=4 Participants
PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 10 mg/kg
PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
Placebo
n=5 Participants
0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 1 mg/kg
n=5 Participants
PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
|---|---|---|---|---|
|
Vss
|
72.0 mL/kg
Interval 58.8 to 85.2
|
—
|
53.9 mL/kg
Interval 49.8 to 57.9
|
73.9 mL/kg
Interval 37.6 to 139.0
|
SECONDARY outcome
Timeframe: Change from Day 1 (Baseline) to Day 57Outcome measures
| Measure |
PRM-151 5 mg/kg
n=5 Participants
PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 10 mg/kg
n=4 Participants
PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
Placebo
n=6 Participants
0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 1 mg/kg
n=5 Participants
PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
|---|---|---|---|---|
|
FVC (Forced Vital Capacity) Change From Baseline to Day 57
|
0.060 liters
Standard Deviation 0.074
|
0.078 liters
Standard Deviation 0.210
|
-0.063 liters
Standard Deviation 0.116
|
0.058 liters
Standard Deviation 0.164
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Day 57Outcome measures
| Measure |
PRM-151 5 mg/kg
n=5 Participants
PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 10 mg/kg
n=4 Participants
PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
Placebo
n=6 Participants
0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 1 mg/kg
n=5 Participants
PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
|---|---|---|---|---|
|
FVC (Forced Vital Capacity) % Predicted Change From Baseline
|
2.8 absolute change in % predicted FVC
Standard Deviation 3.0
|
1.8 absolute change in % predicted FVC
Standard Deviation 5.3
|
-1.5 absolute change in % predicted FVC
Standard Deviation 3.3
|
2.4 absolute change in % predicted FVC
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Day 57Outcome measures
| Measure |
PRM-151 5 mg/kg
n=5 Participants
PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 10 mg/kg
n=4 Participants
PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
Placebo
n=6 Participants
0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 1 mg/kg
n=5 Participants
PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
|---|---|---|---|---|
|
DLCO (%) (Diffusing Capacity of Carbon Monoxide) Change From Baseline
|
-4.0 Absolute change in % predicted DLCO
Standard Deviation 6.8
|
-1.5 Absolute change in % predicted DLCO
Standard Deviation 3.8
|
-2.3 Absolute change in % predicted DLCO
Standard Deviation 2.1
|
0.2 Absolute change in % predicted DLCO
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Day 57Outcome measures
| Measure |
PRM-151 5 mg/kg
n=5 Participants
PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 10 mg/kg
n=4 Participants
PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
Placebo
n=6 Participants
0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 1 mg/kg
n=5 Participants
PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
|---|---|---|---|---|
|
FEV1 (Forced Expiratory Volume 1sec )(%) Change From Baseline
|
2.4 Absolute change in FEV1 % predicted
Standard Deviation 1.1
|
0.3 Absolute change in FEV1 % predicted
Standard Deviation 3.8
|
-1.7 Absolute change in FEV1 % predicted
Standard Deviation 4.3
|
2.6 Absolute change in FEV1 % predicted
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Screening (between Day -35 and Day 1) and Day 57Change from baseline (measured during screening period) in distance walked during a 6 minute walk test
Outcome measures
| Measure |
PRM-151 5 mg/kg
n=5 Participants
PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 10 mg/kg
n=4 Participants
PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
Placebo
n=6 Participants
0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 1 mg/kg
n=5 Participants
PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
|---|---|---|---|---|
|
6MWT (6 Minute Walk Test) Distance Walked Change From Baseline
|
6 meters
Standard Deviation 43
|
35 meters
Standard Deviation 45
|
-11 meters
Standard Deviation 51
|
-11 meters
Standard Deviation 63
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Day 57St. George's Respiratory Questionnaire Total Score. Scores range from 0 (no impairment) to 100 (maximum impairment). A decrease in score represents a decrease in disease related symptoms. The SGRQ is not validated for IPF.
Outcome measures
| Measure |
PRM-151 5 mg/kg
n=5 Participants
PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 10 mg/kg
n=4 Participants
PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
Placebo
n=6 Participants
0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 1 mg/kg
n=5 Participants
PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
|---|---|---|---|---|
|
SGRQ (St. George's Respiratory Questionnaire) Total Score Change From Baseline
|
7.1 units on a scale
Standard Deviation 12.0
|
-6.3 units on a scale
Standard Deviation 6.6
|
-0.5 units on a scale
Standard Deviation 6.2
|
2.3 units on a scale
Standard Deviation 17.9
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
PRM-151 1 mg/kg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
PRM-151 5 mg/kg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PRM-151 10 mg/kg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=6 participants at risk
0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 1 mg/kg
n=6 participants at risk
PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 5 mg/kg
n=5 participants at risk
PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
PRM-151 10 mg/kg
n=4 participants at risk
PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6
|
66.7%
4/6
|
60.0%
3/5
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
33.3%
2/6
|
16.7%
1/6
|
40.0%
2/5
|
25.0%
1/4
|
|
General disorders
Fatigue
|
16.7%
1/6
|
0.00%
0/6
|
40.0%
2/5
|
25.0%
1/4
|
|
Nervous system disorders
Headache
|
16.7%
1/6
|
33.3%
2/6
|
0.00%
0/5
|
25.0%
1/4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
2/6
|
33.3%
2/6
|
0.00%
0/5
|
0.00%
0/4
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6
|
16.7%
1/6
|
20.0%
1/5
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6
|
16.7%
1/6
|
20.0%
1/5
|
0.00%
0/4
|
|
General disorders
Hematoma
|
16.7%
1/6
|
33.3%
2/6
|
0.00%
0/5
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
33.3%
2/6
|
16.7%
1/6
|
0.00%
0/5
|
0.00%
0/4
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
2/6
|
16.7%
1/6
|
0.00%
0/5
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
2/6
|
0.00%
0/6
|
20.0%
1/5
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/6
|
33.3%
2/6
|
0.00%
0/5
|
0.00%
0/4
|
|
Vascular disorders
Hypotension
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/5
|
25.0%
1/4
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
16.7%
1/6
|
16.7%
1/6
|
0.00%
0/5
|
0.00%
0/4
|
|
General disorders
Catheter site hematoma
|
16.7%
1/6
|
16.7%
1/6
|
0.00%
0/5
|
0.00%
0/4
|
|
General disorders
Malaise
|
16.7%
1/6
|
16.7%
1/6
|
0.00%
0/5
|
0.00%
0/4
|
|
Vascular disorders
Hypertension
|
16.7%
1/6
|
16.7%
1/6
|
0.00%
0/5
|
0.00%
0/4
|
|
General disorders
Non-cardiac chest pain
|
33.3%
2/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/4
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators agree that the first public presentation of data will be a joint, multicentre publication of results. If this does not occur within 12 months after conclusion of the study, investigator may publish the results, provided that the complete manuscript or other publication is submitted to the sponsor for review 30 days prior to submission.
- Publication restrictions are in place
Restriction type: OTHER