Trial Outcomes & Findings for Software-Aided Imaging (Morfeus) for Confirming Tumor Coverage With Ablation in Patients With Liver Tumors, the COVER-ALL Study (NCT NCT04083378)
NCT ID: NCT04083378
Last Updated: 2026-03-23
Results Overview
For control group, MAM was assessed by rigid co-registration with side-by-side juxtaposition to verify applicator placement and by visual landmark-based CT measurements on CT workstation (Siemens Healthineers; Forchheim, Germany). For experimental group, CT images were processed with a software-based method on a radiation treatment planning system (Raystation, RaySearch Laboratories; Stockholm, Sweden) with biomechanical deformable imaging registration coupled with AI-based autosegmentation. For experimental group, interventional radiologist (IR) was informed of ablation applicator position relative to tumor on non-contrast CT before thermal ablation energy delivery and of MAM results (including spatial location of suboptimal margins) generated by software-based assessment, with this information not disclosed to IR in control group. Software-based assessment was used to compare MAMs results between both study groups with a two-sample t-test.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
107 participants
Primary outcome timeframe
Visit 2 (baseline/ablation day)
Results posted on
2026-03-23
Participant Flow
MD Anderson Cancer Center
Randomized and non-randomized experimental groups were combined as both received the same ablation confirmation (AC) software. Per DSMB recommendation, an interim stopping rule for control enrollment, which was triggered, halting further accrual. Thus, analyses comparing experimental versus control are presented in this simplified structure to ensure consistency in evaluating the novel AC software for liver tumor ablation.
Participant milestones
| Measure |
Experimental
Clinical impact of Morfeus software usage on patients undergoing percutaneous ablation of hepatic mets
|
Control
Morfeus software was not used during percutaneous ablation of hepatic mets
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
26
|
|
Overall Study
COMPLETED
|
52
|
22
|
|
Overall Study
NOT COMPLETED
|
22
|
4
|
Reasons for withdrawal
| Measure |
Experimental
Clinical impact of Morfeus software usage on patients undergoing percutaneous ablation of hepatic mets
|
Control
Morfeus software was not used during percutaneous ablation of hepatic mets
|
|---|---|---|
|
Overall Study
Death
|
18
|
4
|
|
Overall Study
Lost to Follow-up
|
4
|
0
|
Baseline Characteristics
Software-Aided Imaging (Morfeus) for Confirming Tumor Coverage With Ablation in Patients With Liver Tumors, the COVER-ALL Study
Baseline characteristics by cohort
| Measure |
Experimental
n=74 Participants
Clinical impact of Morfeus software usage on patients undergoing percutaneous ablation of hepatic mets
|
Control
n=26 Participants
Morfeus software was not used during percutaneous ablation of hepatic mets
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
52 Participants
n=10 Participants
|
18 Participants
n=8 Participants
|
70 Participants
n=18 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=10 Participants
|
8 Participants
n=8 Participants
|
30 Participants
n=18 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=10 Participants
|
8 Participants
n=8 Participants
|
39 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=10 Participants
|
18 Participants
n=8 Participants
|
61 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=10 Participants
|
6 Participants
n=8 Participants
|
10 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
69 Participants
n=10 Participants
|
20 Participants
n=8 Participants
|
89 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=10 Participants
|
3 Participants
n=8 Participants
|
11 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=10 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
57 Participants
n=10 Participants
|
18 Participants
n=8 Participants
|
75 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=10 Participants
|
4 Participants
n=8 Participants
|
7 Participants
n=18 Participants
|
|
Region of Enrollment
United States
|
74 participants
n=10 Participants
|
26 participants
n=8 Participants
|
100 participants
n=18 Participants
|
PRIMARY outcome
Timeframe: Visit 2 (baseline/ablation day)Population: The primary endpoint included all enrolled patients
For control group, MAM was assessed by rigid co-registration with side-by-side juxtaposition to verify applicator placement and by visual landmark-based CT measurements on CT workstation (Siemens Healthineers; Forchheim, Germany). For experimental group, CT images were processed with a software-based method on a radiation treatment planning system (Raystation, RaySearch Laboratories; Stockholm, Sweden) with biomechanical deformable imaging registration coupled with AI-based autosegmentation. For experimental group, interventional radiologist (IR) was informed of ablation applicator position relative to tumor on non-contrast CT before thermal ablation energy delivery and of MAM results (including spatial location of suboptimal margins) generated by software-based assessment, with this information not disclosed to IR in control group. Software-based assessment was used to compare MAMs results between both study groups with a two-sample t-test.
Outcome measures
| Measure |
Experimental
n=74 Participants
Clinical impact of Morfeus software usage on patients undergoing percutaneous ablation of liver tumors
|
Control
n=26 Participants
Morfeus software was not used during percutaneous ablation of liver tumors
|
|---|---|---|
|
Minimal Ablative Margin Assessment on Post-ablation Intraprocedural CT.
|
6.8 mm
Standard Deviation 2.9
|
2.2 mm
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Time to local tumor progression (LTP) was measured from ablation to earliest LTP or death (competing event). Follow-up imaging continued up to 24 months.Population: The 2-year secondary endpoints were evaluated for the randomized group
A competing risk analysis was conducted to estimate the 2-year cumulative incidence of local tumor progression. Progression followed ablation reporting standards and RECIST v1.1 (mRECIST for HCC).
Outcome measures
| Measure |
Experimental
n=74 Participants
Clinical impact of Morfeus software usage on patients undergoing percutaneous ablation of liver tumors
|
Control
n=26 Participants
Morfeus software was not used during percutaneous ablation of liver tumors
|
|---|---|---|
|
Cumulative Incidence of 2-year Local Tumor Progression
|
6 percentage of participants
|
17.9 percentage of participants
|
SECONDARY outcome
Timeframe: Overall survival was measured from the date of ablation to the date of death from any cause. Patients still alive were censored at the date of last clinic visit, with follow-up up to 24 months after ablation.Population: The 2-year secondary endpoints were evaluated for the randomized group
The Kaplan-Meier method was used to estimate overall survival
Outcome measures
| Measure |
Experimental
n=74 Participants
Clinical impact of Morfeus software usage on patients undergoing percutaneous ablation of liver tumors
|
Control
n=26 Participants
Morfeus software was not used during percutaneous ablation of liver tumors
|
|---|---|---|
|
Overall Survival
|
73.9 percentage of participants
Interval 64.2 to 85.0
|
83.6 percentage of participants
Interval 70.1 to 99.7
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: The 2-year secondary endpoints are provided in this analysis
Competing risk analysis was conducted to estimate the 2-year intrahepatic (progression outside of ablation zone), considering the progression of the ablated tumor and treating death as a competing event.
Outcome measures
| Measure |
Experimental
n=74 Participants
Clinical impact of Morfeus software usage on patients undergoing percutaneous ablation of liver tumors
|
Control
n=26 Participants
Morfeus software was not used during percutaneous ablation of liver tumors
|
|---|---|---|
|
Intrahepatic Progression-free Survival (for the Randomized Group)
|
34.5 percentage of participants
Interval 24.8 to 47.8
|
41.4 percentage of participants
Interval 25.4 to 67.3
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: The 2-year secondary endpoints are provided in this analysis
Competing risk analysis was conducted to estimate the 2-year extrahepatic cumulative incidence of progression, considering the progression of the ablated tumor and treating death as a competing event.
Outcome measures
| Measure |
Experimental
n=74 Participants
Clinical impact of Morfeus software usage on patients undergoing percutaneous ablation of liver tumors
|
Control
n=26 Participants
Morfeus software was not used during percutaneous ablation of liver tumors
|
|---|---|---|
|
Extrahepatic Progression-free Survival
|
34.5 percentage of participants
Interval 24.8 to 47.8
|
41.4 percentage of participants
Interval 25.4 to 67.3
|
Adverse Events
Experimental
Serious events: 39 serious events
Other events: 18 other events
Deaths: 26 deaths
Control
Serious events: 12 serious events
Other events: 3 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Experimental
n=74 participants at risk
Clinical impact of Morfeus software usage on patients undergoing percutaneous ablation of liver tumors
|
Control
n=26 participants at risk
Morfeus software was not used during the percutaneous ablation of liver tumors
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
10.8%
8/74 • Number of events 11 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
11.5%
3/26 • Number of events 4 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Gastrointestinal disorders
Vomiting
|
5.4%
4/74 • Number of events 4 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
3.8%
1/26 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Gastrointestinal disorders
Nausea
|
4.1%
3/74 • Number of events 3 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
3.8%
1/26 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.4%
1/74 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
3.8%
1/26 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
General disorders
Allergic reaction
|
1.4%
1/74 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
0.00%
0/26 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
1/74 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
0.00%
0/26 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Gastrointestinal disorders
Colonic obstruction
|
2.7%
2/74 • Number of events 2 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
3.8%
1/26 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Infections and infestations
Breast infection
|
1.4%
1/74 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
0.00%
0/26 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Vascular disorders
Bleeding
|
2.7%
2/74 • Number of events 2 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
0.00%
0/26 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
General disorders
Death
|
35.1%
26/74 • Number of events 26 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
23.1%
6/26 • Number of events 6 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Gastrointestinal disorders
Diarrhea
|
4.1%
3/74 • Number of events 3 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
0.00%
0/26 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
General disorders
Dehydration
|
4.1%
3/74 • Number of events 3 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
0.00%
0/26 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/74 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
3.8%
1/26 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.4%
1/74 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
0.00%
0/26 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
General disorders
Fever
|
0.00%
0/74 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
3.8%
1/26 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/74 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
3.8%
1/26 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Cardiac disorders
Heart failure
|
1.4%
1/74 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
0.00%
0/26 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Nervous system disorders
Encephalopathy (liver)
|
1.4%
1/74 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
0.00%
0/26 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Gastrointestinal disorders
Hepatic failure
|
0.00%
0/74 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
3.8%
1/26 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Musculoskeletal and connective tissue disorders
Pain (hip)
|
1.4%
1/74 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
3.8%
1/26 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.4%
1/74 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
0.00%
0/26 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/74 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
3.8%
1/26 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Vascular disorders
Hypotension
|
0.00%
0/74 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
3.8%
1/26 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Infections and infestations
Infection (suspected cholangitis)
|
1.4%
1/74 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
0.00%
0/26 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Vascular disorders
Ischemia (vascular disorder)
|
1.4%
1/74 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
0.00%
0/26 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Infections and infestations
Lung infection
|
1.4%
1/74 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
0.00%
0/26 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/74 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
3.8%
1/26 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Vascular disorders
Portal vein thrombosis
|
1.4%
1/74 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
3.8%
1/26 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Vascular disorders
Thromboembolic event
|
2.7%
2/74 • Number of events 3 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
0.00%
0/26 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Infections and infestations
Sepsis
|
1.4%
1/74 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
0.00%
0/26 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Blood and lymphatic system disorders
Anemia
|
1.4%
1/74 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
0.00%
0/26 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Vascular disorders
Bleeding (vaginal)
|
1.4%
1/74 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
0.00%
0/26 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Infections and infestations
Infection (Urinary Tract)
|
1.4%
1/74 • Number of events 2 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
0.00%
0/26 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.4%
1/74 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
0.00%
0/26 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Investigations
Creatinine increased
|
1.4%
1/74 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
0.00%
0/26 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
Other adverse events
| Measure |
Experimental
n=74 participants at risk
Clinical impact of Morfeus software usage on patients undergoing percutaneous ablation of liver tumors
|
Control
n=26 participants at risk
Morfeus software was not used during the percutaneous ablation of liver tumors
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.8%
5/74 • Number of events 12 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
7.7%
2/26 • Number of events 2 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
1/74 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
0.00%
0/26 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Cardiac disorders
Chest pain
|
1.4%
1/74 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
0.00%
0/26 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Gastrointestinal disorders
Constipation
|
1.4%
1/74 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
0.00%
0/26 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Infections and infestations
Infection (COVID-19)
|
1.4%
1/74 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
0.00%
0/26 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
General disorders
Fatigue
|
1.4%
1/74 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
3.8%
1/26 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
General disorders
Fever
|
1.4%
1/74 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
0.00%
0/26 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Renal and urinary disorders
Hematuria
|
1.4%
1/74 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
0.00%
0/26 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
General disorders
Nausea
|
4.1%
3/74 • Number of events 3 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
0.00%
0/26 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Nervous system disorders
Memory impairment
|
1.4%
1/74 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
0.00%
0/26 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Vascular disorders
Hematoma
|
1.4%
1/74 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
3.8%
1/26 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
General disorders
Rectal pain
|
1.4%
1/74 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
0.00%
0/26 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
1.4%
1/74 • Number of events 1 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
0.00%
0/26 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
|
Gastrointestinal disorders
Vomiting
|
5.4%
4/74 • Number of events 4 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
0.00%
0/26 • Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
|
Additional Information
Dr. Bruno Odisio
The University of Texas MD Anderson Cancer Center
Phone: (713) 563-1066
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place