Trial Outcomes & Findings for Safety and Effectiveness of a New Pleural Catheter for Symptomatic, Recurrent, MPEs Versus Approved Pleural Catheter (NCT NCT02649894)
NCT ID: NCT02649894
Last Updated: 2025-12-11
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
119 participants
Primary outcome timeframe
30 days post catheter insertion
Results posted on
2025-12-11
Participant Flow
Participant milestones
| Measure |
Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
|
Approved Uncoated PleurX Indwelling Pleural Catheter
Approved Uncoated PleurX Indwelling Pleural Catheter
Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
38
|
|
Overall Study
Device Inserted
|
77
|
37
|
|
Overall Study
Completed Day 30
|
56
|
35
|
|
Overall Study
COMPLETED
|
37
|
27
|
|
Overall Study
NOT COMPLETED
|
44
|
11
|
Reasons for withdrawal
| Measure |
Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
|
Approved Uncoated PleurX Indwelling Pleural Catheter
Approved Uncoated PleurX Indwelling Pleural Catheter
Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Death
|
30
|
7
|
|
Overall Study
Other, not specified
|
6
|
0
|
Baseline Characteristics
Safety and Effectiveness of a New Pleural Catheter for Symptomatic, Recurrent, MPEs Versus Approved Pleural Catheter
Baseline characteristics by cohort
| Measure |
Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
n=81 Participants
Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
|
Approved Uncoated PleurX Indwelling Pleural Catheter
n=38 Participants
Approved Uncoated PleurX Indwelling Pleural Catheter
Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.8 years
STANDARD_DEVIATION 10.95 • n=237 Participants
|
66.7 years
STANDARD_DEVIATION 10.35 • n=243 Participants
|
65.4 years
STANDARD_DEVIATION 10.75 • n=480 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
35 Participants
n=237 Participants
|
15 Participants
n=243 Participants
|
50 Participants
n=480 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
45 Participants
n=237 Participants
|
23 Participants
n=243 Participants
|
68 Participants
n=480 Participants
|
|
Sex/Gender, Customized
Gender · Missing
|
1 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
1 Participants
n=480 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=237 Participants
|
1 Participants
n=243 Participants
|
4 Participants
n=480 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=237 Participants
|
3 Participants
n=243 Participants
|
10 Participants
n=480 Participants
|
|
Race (NIH/OMB)
White
|
66 Participants
n=237 Participants
|
34 Participants
n=243 Participants
|
100 Participants
n=480 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
5 Participants
n=480 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=237 Participants
|
29 participants
n=243 Participants
|
93 participants
n=480 Participants
|
|
Region of Enrollment
United Kingdom
|
17 participants
n=237 Participants
|
9 participants
n=243 Participants
|
26 participants
n=480 Participants
|
PRIMARY outcome
Timeframe: 30 days post catheter insertionPopulation: All participants who successfully had the catheter placed.
Outcome measures
| Measure |
Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
n=77 Participants
Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
|
Approved Uncoated PleurX Indwelling Pleural Catheter
n=37 Participants
Approved Uncoated PleurX Indwelling Pleural Catheter
Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter
|
|---|---|---|
|
The Proportion of Subjects Achieving Pleurodesis Without Recurrence.
|
17 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 30 days post insertionPopulation: Participants who had catheter successfully inserted
Outcome measures
| Measure |
Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
n=77 Participants
Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
|
Approved Uncoated PleurX Indwelling Pleural Catheter
n=37 Participants
Approved Uncoated PleurX Indwelling Pleural Catheter
Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter
|
|---|---|---|
|
Time to Confirmed Pleurodesis
|
11.4 days
Standard Deviation 14.44
|
18.7 days
Standard Deviation 19.3
|
SECONDARY outcome
Timeframe: 90 days post insertionPopulation: Participants who had catheter successfully inserted
This endpoint was meant to measure time to recurrence; however, only 1 participant (in the SNCIPC group) had a recurrence so this outcome could not be analyzed.
Outcome measures
| Measure |
Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
n=77 Participants
Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
|
Approved Uncoated PleurX Indwelling Pleural Catheter
n=37 Participants
Approved Uncoated PleurX Indwelling Pleural Catheter
Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter
|
|---|---|---|
|
Time to Recurrence
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 14, Day 30, Day 60, Day 90Population: Participants with catheter successfully placed
Outcome measures
| Measure |
Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
n=77 Participants
Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
|
Approved Uncoated PleurX Indwelling Pleural Catheter
n=37 Participants
Approved Uncoated PleurX Indwelling Pleural Catheter
Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter
|
|---|---|---|
|
Proportion of Surviving Subjects Without a Trapped Lung Diagnosis Following IPC Placement Who Have Confirmed Pleurodesis Without Recurrence at 14, 30, 60, 90 Days.
Day 60
|
0.3261 proportion of participants
|
0.4286 proportion of participants
|
|
Proportion of Surviving Subjects Without a Trapped Lung Diagnosis Following IPC Placement Who Have Confirmed Pleurodesis Without Recurrence at 14, 30, 60, 90 Days.
Day 90
|
0.2500 proportion of participants
|
0.5000 proportion of participants
|
|
Proportion of Surviving Subjects Without a Trapped Lung Diagnosis Following IPC Placement Who Have Confirmed Pleurodesis Without Recurrence at 14, 30, 60, 90 Days.
Day 14
|
0.2222 proportion of participants
|
0.2162 proportion of participants
|
|
Proportion of Surviving Subjects Without a Trapped Lung Diagnosis Following IPC Placement Who Have Confirmed Pleurodesis Without Recurrence at 14, 30, 60, 90 Days.
Day 30
|
0.3019 proportion of participants
|
0.3333 proportion of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days.Population: Participants with successfully placed catheter
Outcome measures
| Measure |
Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
n=77 Participants
Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
|
Approved Uncoated PleurX Indwelling Pleural Catheter
n=37 Participants
Approved Uncoated PleurX Indwelling Pleural Catheter
Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter
|
|---|---|---|
|
Proportion of Subjects With Confirmed Pleurodesis and Without Recurrence 30 Days After IPC Placement by Cancer Type (Lung, Breast and Others).
Lung Cancer
|
0.2222 proportion of participants
|
0.4545 proportion of participants
|
|
Proportion of Subjects With Confirmed Pleurodesis and Without Recurrence 30 Days After IPC Placement by Cancer Type (Lung, Breast and Others).
Breast Cancer
|
0.2000 proportion of participants
|
0.1429 proportion of participants
|
|
Proportion of Subjects With Confirmed Pleurodesis and Without Recurrence 30 Days After IPC Placement by Cancer Type (Lung, Breast and Others).
Other Cancer
|
0.2273 proportion of participants
|
0.3158 proportion of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 daysPopulation: Participants with successfully placed catheter
Outcome measures
| Measure |
Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
n=77 Participants
Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
|
Approved Uncoated PleurX Indwelling Pleural Catheter
n=37 Participants
Approved Uncoated PleurX Indwelling Pleural Catheter
Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter
|
|---|---|---|
|
Incidence of IPC Occlusion
|
15 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 daysPopulation: Participants with successfully placed catheter
Outcome measures
| Measure |
Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
n=77 Participants
Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
|
Approved Uncoated PleurX Indwelling Pleural Catheter
n=37 Participants
Approved Uncoated PleurX Indwelling Pleural Catheter
Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter
|
|---|---|---|
|
Incidence of Empyema and Cellulitis
|
3 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline,Day 7, 14, 30, 45, 75, and 90Population: Participants with successfully placed catheter
Chest pain was measured using a 100 mm VAS scale at baseline and at each subsequent visit. The resulting VAS score ranges from 0 to 100, with 0 indicating "No pain" and 100 indicating "Very severe pain". Therefore, the lower the number, the less chest pain the subject is feeling at the time.
Outcome measures
| Measure |
Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
n=77 Participants
Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
|
Approved Uncoated PleurX Indwelling Pleural Catheter
n=37 Participants
Approved Uncoated PleurX Indwelling Pleural Catheter
Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter
|
|---|---|---|
|
Pain Using 100 mm Visual Analog Scale (VAS)
Day 30
|
10.0 units on a scale
Standard Deviation 18.53
|
10.2 units on a scale
Standard Deviation 19.72
|
|
Pain Using 100 mm Visual Analog Scale (VAS)
Day 45
|
8.4 units on a scale
Standard Deviation 17.84
|
8.6 units on a scale
Standard Deviation 19.68
|
|
Pain Using 100 mm Visual Analog Scale (VAS)
Day 60
|
10.7 units on a scale
Standard Deviation 22.74
|
12.9 units on a scale
Standard Deviation 26.48
|
|
Pain Using 100 mm Visual Analog Scale (VAS)
Day 75
|
7.4 units on a scale
Standard Deviation 19.97
|
6.4 units on a scale
Standard Deviation 17.30
|
|
Pain Using 100 mm Visual Analog Scale (VAS)
Day 90
|
9.6 units on a scale
Standard Deviation 18.41
|
9.2 units on a scale
Standard Deviation 23.21
|
|
Pain Using 100 mm Visual Analog Scale (VAS)
Baseline
|
22.7 units on a scale
Standard Deviation 26.63
|
18.0 units on a scale
Standard Deviation 26.74
|
|
Pain Using 100 mm Visual Analog Scale (VAS)
Day 7
|
16.9 units on a scale
Standard Deviation 26.78
|
10.3 units on a scale
Standard Deviation 20.46
|
|
Pain Using 100 mm Visual Analog Scale (VAS)
Day 14
|
9.8 units on a scale
Standard Deviation 16.62
|
4.6 units on a scale
Standard Deviation 7.82
|
Adverse Events
Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
Serious events: 56 serious events
Other events: 48 other events
Deaths: 30 deaths
Approved Uncoated PleurX Indwelling Pleural Catheter
Serious events: 20 serious events
Other events: 25 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
n=77 participants at risk
Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
|
Approved Uncoated PleurX Indwelling Pleural Catheter
n=37 participants at risk
Approved Uncoated PleurX Indwelling Pleural Catheter
Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter
|
|---|---|---|
|
Infections and infestations
Pleural Infection
|
2.6%
2/77 • Number of events 2 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
2.7%
1/37 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Infections and infestations
Urinary tract infection
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
2.7%
1/37 • Number of events 2 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Infections and infestations
Catheter site infection
|
2.6%
2/77 • Number of events 2 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Infections and infestations
Empyema
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
2.7%
1/37 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Infections and infestations
Lower respiratory tract infection
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
2.7%
1/37 • Number of events 2 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Infections and infestations
Catheter site cellulitis
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Infections and infestations
Gastroenteritis
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Infections and infestations
Infection
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Infections and infestations
Influenza
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Infections and infestations
Neutropenic sepsis
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Infections and infestations
Pneumonia
|
11.7%
9/77 • Number of events 9 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
8.1%
3/37 • Number of events 4 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Infections and infestations
Sepsis
|
3.9%
3/77 • Number of events 3 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
2.7%
1/37 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Infections and infestations
Pneumococcal sepsis
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/77 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
2.7%
1/37 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Infections and infestations
Respiratory tract infection
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
2.6%
2/77 • Number of events 2 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
5.4%
2/37 • Number of events 2 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
2.6%
2/77 • Number of events 2 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
2.6%
2/77 • Number of events 2 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
2.6%
2/77 • Number of events 2 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
2.6%
2/77 • Number of events 2 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
2.7%
1/37 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
2.6%
2/77 • Number of events 2 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
2.6%
2/77 • Number of events 2 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
2.6%
2/77 • Number of events 2 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct adenocarcinoma
|
0.00%
0/77 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
2.7%
1/37 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma malignant
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal cancer metastatic
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/77 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
2.7%
1/37 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/77 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
2.7%
1/37 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
13.0%
10/77 • Number of events 10 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
2.7%
1/37 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.5%
5/77 • Number of events 5 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
2.7%
1/37 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.6%
2/77 • Number of events 2 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
2.7%
1/37 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.6%
2/77 • Number of events 2 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.6%
2/77 • Number of events 2 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.6%
2/77 • Number of events 2 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/77 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
2.7%
1/37 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/77 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
2.7%
1/37 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
General disorders
Device occlusion
|
2.6%
2/77 • Number of events 2 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
General disorders
Asthenia
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
General disorders
Catheter site pain
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
General disorders
Device breakage
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
General disorders
Device dislocation
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/77 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
2.7%
1/37 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
General disorders
Peripheral swelling
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
General disorders
Pyrexia
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/77 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
2.7%
1/37 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Cardiac disorders
Pericardial effusion
|
3.9%
3/77 • Number of events 3 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
2.7%
1/37 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Cardiac disorders
Cardiac tamponade
|
2.6%
2/77 • Number of events 2 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Cardiac disorders
Tachycardia
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
2.7%
1/37 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
2/77 • Number of events 2 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Gastrointestinal disorders
Dysphagia
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/77 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
2.7%
1/37 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/77 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
5.4%
2/37 • Number of events 2 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/77 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
2.7%
1/37 • Number of events 2 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Blood and lymphatic system disorders
Anaemia
|
2.6%
2/77 • Number of events 2 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
2.7%
1/37 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/77 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
2.7%
1/37 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Metabolism and nutrition disorders
Failure to thrive
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/77 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
2.7%
1/37 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Vascular disorders
Deep vein thrombosis
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
2.7%
1/37 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Nervous system disorders
Cerebrovascuar accident
|
0.00%
0/77 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
2.7%
1/37 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Nervous system disorders
Syncope
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/77 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
2.7%
1/37 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Psychiatric disorders
Mental status change
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/77 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
2.7%
1/37 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/77 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
2.7%
1/37 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/77 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
2.7%
1/37 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
Other adverse events
| Measure |
Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
n=77 participants at risk
Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
|
Approved Uncoated PleurX Indwelling Pleural Catheter
n=37 participants at risk
Approved Uncoated PleurX Indwelling Pleural Catheter
Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
14.3%
11/77 • Number of events 12 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
5.4%
2/37 • Number of events 2 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.4%
8/77 • Number of events 10 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
8.1%
3/37 • Number of events 3 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.2%
4/77 • Number of events 4 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
5.4%
2/37 • Number of events 2 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.6%
2/77 • Number of events 2 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
5.4%
2/37 • Number of events 2 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Blood and lymphatic system disorders
Anaemia
|
11.7%
9/77 • Number of events 13 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
8.1%
3/37 • Number of events 4 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Gastrointestinal disorders
Constipation
|
2.6%
2/77 • Number of events 2 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
10.8%
4/37 • Number of events 4 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Gastrointestinal disorders
Nausea
|
3.9%
3/77 • Number of events 3 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
5.4%
2/37 • Number of events 2 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
General disorders
Catheter site pain
|
10.4%
8/77 • Number of events 9 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
10.8%
4/37 • Number of events 4 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
General disorders
Pyrexia
|
9.1%
7/77 • Number of events 7 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
0.00%
0/37 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
General disorders
Non-cardiac chest pain
|
2.6%
2/77 • Number of events 2 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
8.1%
3/37 • Number of events 3 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Infections and infestations
Urinary tract infection
|
3.9%
3/77 • Number of events 3 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
8.1%
3/37 • Number of events 3 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
8.1%
3/37 • Number of events 3 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Investigations
C-reactive protein increased
|
3.9%
3/77 • Number of events 3 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
5.4%
2/37 • Number of events 2 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Investigations
Breath sounds abnormal
|
1.3%
1/77 • Number of events 1 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
5.4%
2/37 • Number of events 2 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
|
Investigations
Blood chloride decreased
|
0.00%
0/77 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
5.4%
2/37 • Number of events 2 • 90 Days
Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place