Trial Outcomes & Findings for Treatment of Peripheral Arterial Hemorrhage With Lava LES (The LAVA Study) (NCT NCT04649255)
NCT ID: NCT04649255
Last Updated: 2024-04-12
Results Overview
A composite of freedom from 30-day MAEs include ischemia or infarction of the target territory, non-target embolization, allergic reactions to Lava, catheter breakage, and catheter entrapment defined as the inability to withdraw a catheter from adherence to Lava.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
113 participants
Primary outcome timeframe
30 Days
Results posted on
2024-04-12
Participant Flow
Subject screening commenced on April 14, 2021 with the first subject enrolled on April 14, 2021. 160 subjects were screened at 20 investigational sites in the United States of America with no more than 25 subjects enrolled at any single site. 113 subjects were enrolled (successful arterial access established to the target lesion) at 19 sites in the Intent to treat (ITT) population.
Participant milestones
| Measure |
Lava LES
Liquid Embolic: Lava Liquid Embolic System (LES)
|
|---|---|
|
Overall Study
STARTED
|
113
|
|
Overall Study
COMPLETED
|
103
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Lava LES
Liquid Embolic: Lava Liquid Embolic System (LES)
|
|---|---|
|
Overall Study
Death
|
9
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Out of the overall 113 participants, race data was available for 108 participants.
Baseline characteristics by cohort
| Measure |
Lava LES
n=113 Participants
Liquid Embolic: Lava Liquid Embolic System (LES)
|
|---|---|
|
Age, Continuous
|
57.4 years
n=113 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=113 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=113 Participants
|
|
Race/Ethnicity, Customized
Asian
|
10 Participants
n=108 Participants • Out of the overall 113 participants, race data was available for 108 participants.
|
|
Race/Ethnicity, Customized
Black or African-American
|
16 Participants
n=108 Participants • Out of the overall 113 participants, race data was available for 108 participants.
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 Participants
n=108 Participants • Out of the overall 113 participants, race data was available for 108 participants.
|
|
Race/Ethnicity, Customized
White
|
63 Participants
n=108 Participants • Out of the overall 113 participants, race data was available for 108 participants.
|
|
Race/Ethnicity, Customized
Other (Not otherwise specified)
|
18 Participants
n=108 Participants • Out of the overall 113 participants, race data was available for 108 participants.
|
|
Body Mass Index (BMI)
|
28.9 kg/m^2
STANDARD_DEVIATION 6.88 • n=113 Participants
|
|
Target Bleed Territory - Upper GI
Upper GI
|
11 Participants
n=113 Participants
|
|
Target Bleed Territory - Upper GI
Lower GI
|
10 Participants
n=113 Participants
|
|
Target Bleed Territory - Upper GI
Non-GI Visceral
|
41 Participants
n=113 Participants
|
|
Target Bleed Territory - Upper GI
Extremity
|
8 Participants
n=113 Participants
|
|
Target Bleed Territory - Upper GI
Other (Not otherwise specified)
|
43 Participants
n=113 Participants
|
|
Etiology of Bleeding
Traumatic, non-iatrogenic
|
32 Participants
n=113 Participants
|
|
Etiology of Bleeding
Iatrogenic
|
29 Participants
n=113 Participants
|
|
Etiology of Bleeding
Ulcer
|
5 Participants
n=113 Participants
|
|
Etiology of Bleeding
Benign Neoplasm
|
1 Participants
n=113 Participants
|
|
Etiology of Bleeding
Malignant Neoplasm
|
5 Participants
n=113 Participants
|
|
Etiology of Bleeding
Mallory Weiss Tear
|
0 Participants
n=113 Participants
|
|
Etiology of Bleeding
Congenital Vascular Lesion
|
0 Participants
n=113 Participants
|
|
Etiology of Bleeding
Unknown
|
6 Participants
n=113 Participants
|
|
Etiology of Bleeding
Other (Not otherwise specified)
|
35 Participants
n=113 Participants
|
|
Currently Taking Antiplatelet Agents
|
9 Participants
n=96 Participants • Difference between number analyzed and overall was due to missing data.
|
|
Currently Taking Anticoagulant Agents
|
8 Participants
n=90 Participants • Difference between number analyzed and overall was due to missing data.
|
PRIMARY outcome
Timeframe: 30 DaysPopulation: Analysis based on the intent-to-treat (ITT) population with valid assessment. The baseline number of subjects was 113 but only 101 subjects were administered the assigned intervention (Lava LES), thus 101 subjects were evaluable.
A composite of freedom from 30-day MAEs include ischemia or infarction of the target territory, non-target embolization, allergic reactions to Lava, catheter breakage, and catheter entrapment defined as the inability to withdraw a catheter from adherence to Lava.
Outcome measures
| Measure |
Lava LES
n=101 Participants
Liquid Embolic: Lava Liquid Embolic System (LES)
|
|---|---|
|
Percentage of Participants With Composite of Freedom From Major Adverse Events (MAEs)
|
100 percentage of participants
Interval 96.4 to 100.0
|
PRIMARY outcome
Timeframe: 30 daysPopulation: Analysis based on the intent-to-treat (ITT) population with valid assessment.
Defined as absence of bleeding from the target lesion after embolization with the Lava LES, without the need for emergency surgery, re-embolization, or other target lesion reinterventions.
Outcome measures
| Measure |
Lava LES
n=141 number of lesions
Liquid Embolic: Lava Liquid Embolic System (LES)
|
|---|---|
|
Percentage of Lesions to Achieve Clinical Success
|
94.3 percentage of lesions
Interval 89.1 to 97.5
|
Adverse Events
Lava LES
Serious events: 49 serious events
Other events: 92 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Lava LES
n=113 participants at risk
Liquid Embolic: Lava Liquid Embolic System (LES)
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.7%
3/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Blood and lymphatic system disorders
Chronic myeloid leukaemia
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Cardiac disorders
Atrial fibrillation
|
1.8%
2/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Cardiac disorders
Cardiac arrest
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Cardiac disorders
Chest pain
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.8%
2/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Gastrointestinal disorders
Haematochezia
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Gastrointestinal disorders
Ileus
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Gastrointestinal disorders
Melaena
|
1.8%
2/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
General disorders
Death
|
2.7%
3/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
General disorders
Flank pain
|
1.8%
2/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Hepatobiliary disorders
Cholangitis infective
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Hepatobiliary disorders
Gallbladder rupture
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Infections and infestations
Sepsis
|
3.5%
4/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
1.8%
2/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Metabolism and nutrition disorders
Acute respiratory failure
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Metabolism and nutrition disorders
Respiratory failure
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Respiratory, thoracic and mediastinal disorders
COVID-19
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Surgical and medical procedures
Colectomy
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Vascular disorders
Cardiogenic shock
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Vascular disorders
Epistaxis
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Vascular disorders
Extravasation blood
|
2.7%
3/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Vascular disorders
Haematoma infection
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Vascular disorders
Hepatic haemorrhage
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Vascular disorders
Hypotension
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Vascular disorders
Pulmonary embolism
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Vascular disorders
Retroperitoneal haematoma
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Vascular disorders
Septic shock
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Vascular disorders
Shock haemorrhagic
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
Other adverse events
| Measure |
Lava LES
n=113 participants at risk
Liquid Embolic: Lava Liquid Embolic System (LES)
|
|---|---|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Cardiac disorders
Ascites
|
1.8%
2/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Cardiac disorders
Dizziness
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Cardiac disorders
Tachycardia
|
3.5%
4/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Endocrine disorders
Hypoglycaemia
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.7%
11/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
1.8%
2/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Gastrointestinal disorders
Colitis
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Gastrointestinal disorders
Constipation
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.7%
3/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Gastrointestinal disorders
Duodenitis
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Gastrointestinal disorders
Nausea
|
3.5%
4/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Gastrointestinal disorders
Omental haemorrhage
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Gastrointestinal disorders
Pancreatic pseudocyst
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Gastrointestinal disorders
Vomiting
|
4.4%
5/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
General disorders
Cachexia
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
General disorders
Oedema
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
General disorders
Peripheral swelling
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
General disorders
Pyrexia
|
3.5%
4/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Hepatobiliary disorders
Haemangioma of liver
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Immune system disorders
Infusion related reaction
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Infections and infestations
Bacteraemia
|
1.8%
2/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Infections and infestations
Clostridium difficile infection
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Infections and infestations
Localised infection
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Infections and infestations
Peritonitis
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Infections and infestations
Postoperative wound infection
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Investigations
Haemoglobin decreased
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Investigations
International normalised ratio increased
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Investigations
Klebsiella test positive
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Investigations
White blood cell count increased
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Investigations
Acidosis
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Investigations
Dehydration
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Investigations
Hyperkalaemia
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Investigations
Lactic acidosis
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Investigations
Tumour lysis syndrome
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Investigations
Arthralgia
|
2.7%
3/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Investigations
Back pain
|
1.8%
2/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Investigations
Groin pain
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Investigations
Inguinal mass
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Investigations
Joint swelling
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Investigations
Pain in extremity
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Nervous system disorders
Encephalopathy
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Nervous system disorders
Headache
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Nervous system disorders
Somnolence
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Psychiatric disorders
Confusional state
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Psychiatric disorders
Suicidal ideation
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Renal and urinary disorders
Anuria
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Renal and urinary disorders
Renal failure
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Renal and urinary disorders
Urinary tract infection
|
1.8%
2/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Renal and urinary disorders
Urosepsis
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.8%
2/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.8%
2/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Respiratory, thoracic and mediastinal disorders
Musculoskeletal chest pain
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.8%
2/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal ulcer
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Skin and subcutaneous tissue disorders
Paraesthesia
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Surgical and medical procedures
Dialysis device insertion
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Surgical and medical procedures
Nephrostomy
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Surgical and medical procedures
Pancreatic duct drainage
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Surgical and medical procedures
Transfusion
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Vascular disorders
Contusion
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Vascular disorders
Deep vein thrombosis
|
1.8%
2/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Vascular disorders
Haematoma
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Vascular disorders
Haemorrhage
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Vascular disorders
Hepatic haemorrhage
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Vascular disorders
Hypertension
|
2.7%
3/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Vascular disorders
Renal infarct
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Vascular disorders
Splenic haemorrhage
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
|
Vascular disorders
Splenic infarction
|
0.88%
1/113 • Up to 6 weeks.
Note: The primary and secondary safety endpoints were the major AEs at 30 days, and All-Cause Mortality through 30 days follow-up, hence the difference in the denominators. The denominator for total number of treated participants was 113, which was used for all general AE and SAE tables. The denominator for All-Cause Mortality was actually 109 because 4 participants were excluded due to exiting the study before the 30-day follow-up visit, without death.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place