Trial Outcomes & Findings for Ipilimumab + Nivolumab + Cryotherapy in Metastatic or Locally Advanced Soft Tissue Sarcoma (NCT NCT04118166)
NCT ID: NCT04118166
Last Updated: 2023-12-12
Results Overview
Clinical benefit was assessed on the basis of clinical response per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria: * Complete response (CR) = Disappearance of all target lesions; all lymph nodes \< 10 mm on the short axis; no new lesions. * Partial response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions; no new lesions. * Stable disease (SD) = Small changes that do not meet any of the above criteria; no new lesions. * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s). Clinical benefit was defined as CR + PR. The primary outcome is expressed as the total number of participants who receive clinical benefit within 14 weeks, a number without dispersion. Rates of all clinical responses are reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
14 weeks
Results posted on
2023-12-12
Participant Flow
Participant milestones
| Measure |
Ipilimumab/Nivolumab + Cryotherapy
1 mg/kg with nivolumab 3 mg/kg every 3 weeks x 4 doses. (One cycle of treatment is 3 weeks). Cryotherapy (cryoablation) will be performed between investigational agent treatment Cycles 1 and 2
Ipilimumab: Ipilimumab 1 mg/kg, injection
Cryoablation: Cryoablation of the tumors occur between investigational agent treatment Cycles 1 and 2, and will be performed according to standard procedures
Nivolumab: Nivolumab 3 mg/kg, injection
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Ipilimumab/Nivolumab + Cryotherapy
1 mg/kg with nivolumab 3 mg/kg every 3 weeks x 4 doses. (One cycle of treatment is 3 weeks). Cryotherapy (cryoablation) will be performed between investigational agent treatment Cycles 1 and 2
Ipilimumab: Ipilimumab 1 mg/kg, injection
Cryoablation: Cryoablation of the tumors occur between investigational agent treatment Cycles 1 and 2, and will be performed according to standard procedures
Nivolumab: Nivolumab 3 mg/kg, injection
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Ipilimumab + Nivolumab + Cryotherapy in Metastatic or Locally Advanced Soft Tissue Sarcoma
Baseline characteristics by cohort
| Measure |
Ipilimumab/Nivolumab + Cryotherapy
n=30 Participants
1 mg/kg with nivolumab 3 mg/kg every 3 weeks x 4 doses. (One cycle of treatment is 3 weeks). Cryotherapy (cryoablation) will be performed between investigational agent treatment Cycles 1 and 2
Ipilimumab: Ipilimumab 1 mg/kg, injection
Cryoablation: Cryoablation of the tumors occur between investigational agent treatment Cycles 1 and 2, and will be performed according to standard procedures
Nivolumab: Nivolumab 3 mg/kg, injection
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
55.0 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 weeksPopulation: Does not include participants taken off-study, and not evaluated for the outcome.
Clinical benefit was assessed on the basis of clinical response per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria: * Complete response (CR) = Disappearance of all target lesions; all lymph nodes \< 10 mm on the short axis; no new lesions. * Partial response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions; no new lesions. * Stable disease (SD) = Small changes that do not meet any of the above criteria; no new lesions. * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s). Clinical benefit was defined as CR + PR. The primary outcome is expressed as the total number of participants who receive clinical benefit within 14 weeks, a number without dispersion. Rates of all clinical responses are reported.
Outcome measures
| Measure |
Ipilimumab/Nivolumab + Cryotherapy
n=29 Participants
1 mg/kg with nivolumab 3 mg/kg every 3 weeks x 4 doses. (One cycle of treatment is 3 weeks). Cryotherapy (cryoablation) will be performed between investigational agent treatment Cycles 1 and 2
Ipilimumab: Ipilimumab 1 mg/kg, injection
Cryoablation: Cryoablation of the tumors occur between investigational agent treatment Cycles 1 and 2, and will be performed according to standard procedures
Nivolumab: Nivolumab 3 mg/kg, injection
|
|---|---|
|
Clinical Response
Complete Response (CR)
|
0 Participants
|
|
Clinical Response
Partial Response (PR)
|
3 Participants
|
|
Clinical Response
Stable Disease (SD)
|
7 Participants
|
|
Clinical Response
Progressive disease (PD)
|
19 Participants
|
SECONDARY outcome
Timeframe: 24 monthsAdverse events were assessed per CTCAE version 5. The outcome is those adverse events experienced by participants that were determined to be possibly, probably, or definitely-related to study treatment. Serious adverse events are identified by the term "SAE." Results are presented as the number of related adverse events by preferred term that occurred. The data are numbers without dispersion.
Outcome measures
| Measure |
Ipilimumab/Nivolumab + Cryotherapy
n=30 Participants
1 mg/kg with nivolumab 3 mg/kg every 3 weeks x 4 doses. (One cycle of treatment is 3 weeks). Cryotherapy (cryoablation) will be performed between investigational agent treatment Cycles 1 and 2
Ipilimumab: Ipilimumab 1 mg/kg, injection
Cryoablation: Cryoablation of the tumors occur between investigational agent treatment Cycles 1 and 2, and will be performed according to standard procedures
Nivolumab: Nivolumab 3 mg/kg, injection
|
|---|---|
|
Related Adverse Events (Toxicity)
Hoarse voice
|
1 Related adverse events
|
|
Related Adverse Events (Toxicity)
Ringing in the ears (tinnitus)
|
1 Related adverse events
|
|
Related Adverse Events (Toxicity)
Adrenal insufficiency
|
1 Related adverse events
|
|
Related Adverse Events (Toxicity)
Hyperthyroidism (excess levels of thyroxine hormone)
|
3 Related adverse events
|
|
Related Adverse Events (Toxicity)
Hypothyroidism (diminished levels of thyroxine hormone)
|
4 Related adverse events
|
|
Related Adverse Events (Toxicity)
Hypophysitis (inflammation of the pituitary gland)
|
1 Related adverse events
|
|
Related Adverse Events (Toxicity)
Diarrhea
|
4 Related adverse events
|
|
Related Adverse Events (Toxicity)
Diarrhea (intermittent)
|
1 Related adverse events
|
|
Related Adverse Events (Toxicity)
Dry mouth
|
2 Related adverse events
|
|
Related Adverse Events (Toxicity)
Allergic reaction
|
1 Related adverse events
|
|
Related Adverse Events (Toxicity)
Thyroid stimulating hormone (TSH) elevated
|
2 Related adverse events
|
|
Related Adverse Events (Toxicity)
Alanine aminotransferase (ALT) elevated
|
1 Related adverse events
|
|
Related Adverse Events (Toxicity)
Hyponatremia (blood sodium level decreased)
|
2 Related adverse events
|
|
Related Adverse Events (Toxicity)
Neuropathy, peripheral sensory
|
1 Related adverse events
|
|
Related Adverse Events (Toxicity)
Numbness, bilateral hand, intermittent
|
1 Related adverse events
|
|
Related Adverse Events (Toxicity)
Pain, neuropathic
|
1 Related adverse events
|
|
Related Adverse Events (Toxicity)
Cough, all descriptions
|
4 Related adverse events
|
|
Related Adverse Events (Toxicity)
Dyspnea (shortness of breath)
|
3 Related adverse events
|
|
Related Adverse Events (Toxicity)
Pneumonitis (lung inflammation)
|
1 Related adverse events
|
|
Related Adverse Events (Toxicity)
Pneumonitis (lung inflammation) (SAE)
|
1 Related adverse events
|
|
Related Adverse Events (Toxicity)
Rash, all descriptions
|
12 Related adverse events
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Immune-related Response Evaluation Criteria in Solid Tumors (ir-RECIST) was not assessed/collected for some subjects, and cannot be reported. Reasons that ir-RECIST was not assessed included death, adverse event, and withdrawal/lost-to-follow-up subsequent to PD determination per RECIST at 14 weeks.
The immune-related (ir) clinical response will be assessed per the immune-related Response Evaluation Criteria in Solid Tumors (ir-RECIST) criteria, as follows: * Complete response (CR) = Disappearance of all lesions, with any pathological lymph nodes having a reduction in short axis to \< 10 mm; no new lesions \> 5 × 5 mm in size. * Partial response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions. * Stable disease (SD) = Small changes that do not meet any of the these criteria; no new lesions \> 5 × 5 mm in size. * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions with the sum of diameters increasing ≥ 5 mm, and/or the appearance of 1+ new lesion(s). Note that irRECIST differs from RECIST criteria. The outcome is expressed as the total number of participants who achieve a ir-clinical response (ie, CR + PR) by 16 weeks, a number without dispersion.
Outcome measures
| Measure |
Ipilimumab/Nivolumab + Cryotherapy
n=25 Participants
1 mg/kg with nivolumab 3 mg/kg every 3 weeks x 4 doses. (One cycle of treatment is 3 weeks). Cryotherapy (cryoablation) will be performed between investigational agent treatment Cycles 1 and 2
Ipilimumab: Ipilimumab 1 mg/kg, injection
Cryoablation: Cryoablation of the tumors occur between investigational agent treatment Cycles 1 and 2, and will be performed according to standard procedures
Nivolumab: Nivolumab 3 mg/kg, injection
|
|---|---|
|
Immune-related Clinical Response (irRECIST) Rate
Complete response (CR)
|
0 Participants
|
|
Immune-related Clinical Response (irRECIST) Rate
Partial response (PR)
|
3 Participants
|
|
Immune-related Clinical Response (irRECIST) Rate
Stable disease (SD)
|
7 Participants
|
|
Immune-related Clinical Response (irRECIST) Rate
Progressive disease (PD)
|
15 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Does not include participants taken off-study, and not evaluated for the outcome.
Progression-free survival (PFS) is a measure of participants remaining alive without disease progression. The outcome is expressed as the total number of participants remaining alive without disease progression at 6 months after consent, a number without dispersion.
Outcome measures
| Measure |
Ipilimumab/Nivolumab + Cryotherapy
n=29 Participants
1 mg/kg with nivolumab 3 mg/kg every 3 weeks x 4 doses. (One cycle of treatment is 3 weeks). Cryotherapy (cryoablation) will be performed between investigational agent treatment Cycles 1 and 2
Ipilimumab: Ipilimumab 1 mg/kg, injection
Cryoablation: Cryoablation of the tumors occur between investigational agent treatment Cycles 1 and 2, and will be performed according to standard procedures
Nivolumab: Nivolumab 3 mg/kg, injection
|
|---|---|
|
Progression-free Survival (PFS)
|
3 Participants
|
Adverse Events
Ipilimumab/Nivolumab + Cryotherapy
Serious events: 30 serious events
Other events: 30 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
Ipilimumab/Nivolumab + Cryotherapy
n=30 participants at risk
1 mg/kg with nivolumab 3 mg/kg every 3 weeks x 4 doses. (One cycle of treatment is 3 weeks). Cryotherapy (cryoablation) will be performed between investigational agent treatment Cycles 1 and 2
Ipilimumab: Ipilimumab 1 mg/kg, injection
Cryoablation: Cryoablation of the tumors occur between investigational agent treatment Cycles 1 and 2, and will be performed according to standard procedures
Nivolumab: Nivolumab 3 mg/kg, injection
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
13.3%
4/30 • Number of events 4 • 2 years
|
|
Cardiac disorders
Cardiac arrest
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Endocrine disorders
Adrenal insufficiency
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Investigations
Blood bilirubin increased
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Investigations
Alkaline phosphatase increased
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Investigations
Elevated ALT
|
6.7%
2/30 • Number of events 3 • 2 years
|
|
Investigations
Elevated AST
|
6.7%
2/30 • Number of events 3 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other, Disease Progression (death)
|
50.0%
15/30 • Number of events 15 • 2 years
|
|
Nervous system disorders
Muscle weakness, right-sided
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Nervous system disorders
Other, Motor deficit, right side
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Hematuria
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Proteinuria
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Intermittent bronchopulmonary hemorrhage
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Right apical pneumothorax
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Right pleural effusion
|
3.3%
1/30 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
Ipilimumab/Nivolumab + Cryotherapy
n=30 participants at risk
1 mg/kg with nivolumab 3 mg/kg every 3 weeks x 4 doses. (One cycle of treatment is 3 weeks). Cryotherapy (cryoablation) will be performed between investigational agent treatment Cycles 1 and 2
Ipilimumab: Ipilimumab 1 mg/kg, injection
Cryoablation: Cryoablation of the tumors occur between investigational agent treatment Cycles 1 and 2, and will be performed according to standard procedures
Nivolumab: Nivolumab 3 mg/kg, injection
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
13.3%
4/30 • Number of events 15 • 2 years
|
|
Blood and lymphatic system disorders
Other, Deep vein thrombois (DVT) of catheter
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Cardiac disorders
Atrial fibrillation
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Cardiac disorders
Intermittent heart palpitations
|
6.7%
2/30 • Number of events 2 • 2 years
|
|
Cardiac disorders
Pericarditis
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Cardiac disorders
Tachycardia
|
6.7%
2/30 • Number of events 2 • 2 years
|
|
Cardiac disorders
Other, Decreased pulse
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Ear and labyrinth disorders
Ringing in the ears (tinnitus)
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Endocrine disorders
Adrenal insufficiency
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Endocrine disorders
Hyperthyroidism
|
10.0%
3/30 • Number of events 3 • 2 years
|
|
Endocrine disorders
Hypophysitis
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Endocrine disorders
Hypothyroidism
|
13.3%
4/30 • Number of events 4 • 2 years
|
|
Eye disorders
Dry eyes
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Eye disorders
Flashing lights
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Eye disorders
Intermittent brief blurry vision
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Eye disorders
Keratitis
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Eye disorders
L eye redness
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Eye disorders
L eye pain
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Eye disorders
L eye burning sensation
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Eye disorders
L eye blurred vision
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Eye disorders
R eye blurred vision
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Eye disorders
Other, Corneal abrasion
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Abdominal bloating
|
6.7%
2/30 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Intermittent abdominal bloating
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
13.3%
4/30 • Number of events 4 • 2 years
|
|
Gastrointestinal disorders
Increased abdominal pain
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
16.7%
5/30 • Number of events 5 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
3/30 • Number of events 4 • 2 years
|
|
Gastrointestinal disorders
Diarrhea (intermittent)
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Dry mouth
|
6.7%
2/30 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
16.7%
5/30 • Number of events 6 • 2 years
|
|
Gastrointestinal disorders
Intermittent nausea
|
6.7%
2/30 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Intermittent nausea/vomiting
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Other, Decreased appetite
|
10.0%
3/30 • Number of events 3 • 2 years
|
|
Gastrointestinal disorders
Other, Lack of appetite
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Other, Mucositis
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
General disorders
Chest Pain
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
General disorders
Fatigue
|
30.0%
9/30 • Number of events 9 • 2 years
|
|
General disorders
Fever
|
13.3%
4/30 • Number of events 4 • 2 years
|
|
General disorders
Intermittent fever
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
General disorders
Low grade fever
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
General disorders
Flu-like symptoms
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
General disorders
Intermittent chest pain to R sternal border exacerbated with deep inhalation
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
General disorders
Intermittent fatigue
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
General disorders
Intermittent chills followed by hot flashes
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
General disorders
Pain
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Immune system disorders
Allergic reaction
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Infections and infestations
Gum infection
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Infections and infestations
UTI
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Infections and infestations
Other, Infectious diarrhea
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Infections and infestations
Other, Presumed pneumonia
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Investigations
Creatinine increased
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Investigations
Elevated TSH
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Investigations
TSH increased
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Investigations
Decreased WBC count
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Investigations
Alkaline phosphatase increased
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Investigations
Elevated ALT
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Investigations
Weight loss
|
13.3%
4/30 • Number of events 4 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.7%
2/30 • Number of events 2 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgias
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle and joint aches
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Lower back throbbing pain
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Right neck pain
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Right shoulder pain (Pain in extremity)
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Other, Gluteal pain and swelling
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Other, Arm pain left
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Other, Muscle aches and fatigue associated with COVID vaccine
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Other, Right thigh pain
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Other, Soreness to right lateral ribs
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Other, Soreness at site of recent cryoablation (R lung)
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Other, Soreness right chest wall
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Other, Soreness to left side at site of recent cryoablation
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Other, Soreness, right shoulder
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Other, Pain to right chest wall at recent site of cryo
|
6.7%
2/30 • Number of events 2 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Other, Pelvic bone pain
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Other, Intermittent peripheral edema
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Other, Weakness to left shoulder
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Nervous system disorders
Worsening left leg weakness
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Nervous system disorders
Dizziness
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Nervous system disorders
Headache
|
6.7%
2/30 • Number of events 2 • 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Nervous system disorders
Muscle weakness, left-sided
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Nervous system disorders
Muscle weakness, right-sided
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Nervous system disorders
Neuropathy under R axilla
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Nervous system disorders
Other, Intermittent bilateral hand numbness
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Nervous system disorders
Other, Motor deficit, left side
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Nervous system disorders
Other, Motor deficit, right side
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Nervous system disorders
Other, Neuropathic pain
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Nervous system disorders
Other, Occasional twitching sensation to anterior chest wall
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Nervous system disorders
Other, Intermittent left sciatic pain
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Worsening anxiety
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Anxiety
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Confusion
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Insomnia
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Depression
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Intermittent hematuria
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Hematuria
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Proteinuria
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Blood tinge sputum
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.3%
7/30 • Number of events 8 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Intermittent cough
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Intermittent cough w/chest tightness
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Intermittent cough with Blood tinge sputum
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dry cough
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
10.0%
3/30 • Number of events 3 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Worsening cough
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
3/30 • Number of events 3 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath with exertion
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarse voice
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Right pneumothorax
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Right apical pneumothorax
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Tension pneumothorax (requiring ICU stay)
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection (COVID-19)
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.7%
2/30 • Number of events 2 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Intermittent wheezing
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Other, Hemoptysis
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Facial rash
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.3%
4/30 • Number of events 4 • 2 years
|
|
Skin and subcutaneous tissue disorders
Maculo-papular rash
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Maculo-papular rash to bilateral arms
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Post-inflammatory hyperpigmentation on left breast
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
16.7%
5/30 • Number of events 5 • 2 years
|
|
Skin and subcutaneous tissue disorders
Tinea
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Other, Burned hand
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Other, Hair thinning
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Other, Leg ulcer left
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Other, Molluscum contagiousum on left arm
|
3.3%
1/30 • Number of events 1 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place