Trial Outcomes & Findings for Envarsus XR in Lung Transplant (NCT NCT04420195)
NCT ID: NCT04420195
Last Updated: 2024-01-22
Results Overview
The primary endpoint is the percentage of patients remaining on Envarsus XR at the 1-year follow-up visit.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
1 Year Post-Transplant
Results posted on
2024-01-22
Participant Flow
41 individuals were enrolled to participate in the trial; 1 individual did not begin treatment in the study, thus, only 40 participants started the study. Data on 24 historical control individuals were collected and analyzed retrospectively for the secondary outcome measures, but these 24 individuals were not recruited nor enrolled into the study, thus, they are not reflected in the total Protocol Enrollment figure.
Participant milestones
| Measure |
Envarsus XR
Envarsus XR to be initiated once patient is tolerating oral medications
Extended-Release Tacrolimus: Envarsus XR is an FDA-approved drug for the prophylaxis of organ rejection in de novo kidney transplant patients or in kidney transplant patients converted from IR tacrolimus when used with other immunosuppressants. Envarsus XR is a novel extended-release formulation of tacrolimus created using MeltDose technology. Envarsus XR is available in tablet form. It is available in 0.75, 1, and 4 mg tablets.
|
IR Tacrolimus (Historical Control)
Historical cohort of patients maintained on IR tacrolimus following transplant. These patients were not enrolled in the trial as participants.
Immediate-Release Tacrolimus: Historical cohort of 20 subjects who will be maintained on IR tacrolimus following transplant. Dosing will be converted on an individual basis (Capsules: 0.5 mg, 1 mg and 5 mg or Injection: 5 mg) . All patients will be initiated on IR tacrolimus either under the tongue (sublingual) or as a solution given through a tube placed through the nose into the stomach, which is standard of care for all lung transplant recipients.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
24
|
|
Overall Study
COMPLETED
|
40
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Envarsus XR in Lung Transplant
Baseline characteristics by cohort
| Measure |
Envarsus XR
n=40 Participants
Envarsus XR to be initiated once patient is tolerating oral medications
Extended-Release Tacrolimus: Envarsus XR is an FDA-approved drug for the prophylaxis of organ rejection in de novo kidney transplant patients or in kidney transplant patients converted from IR tacrolimus when used with other immunosuppressants. Envarsus XR is a novel extended-release formulation of tacrolimus created using MeltDose technology. Envarsus XR is available in tablet form. It is available in 0.75, 1, and 4 mg tablets.
|
IR Tacrolimus (Historical Control)
n=24 Participants
Historical cohort of patients maintained on IR tacrolimus following transplant
Immediate-Release Tacrolimus: Historical cohort of 20 subjects who will be maintained on IR tacrolimus following transplant. Dosing will be converted on an individual basis (Capsules: 0.5 mg, 1 mg and 5 mg or Injection: 5 mg) . All patients will be initiated on IR tacrolimus either under the tongue (sublingual) or as a solution given through a tube placed through the nose into the stomach, which is standard of care for all lung transplant recipients.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
n=99 Participants
|
62.5 years
n=107 Participants
|
60.75 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
18 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=99 Participants
|
24 participants
n=107 Participants
|
64 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 Year Post-TransplantThe primary endpoint is the percentage of patients remaining on Envarsus XR at the 1-year follow-up visit.
Outcome measures
| Measure |
Envarsus XR
n=40 Participants
Envarsus XR to be initiated once patient is tolerating oral medications
Extended-Release Tacrolimus: Envarsus XR is an FDA-approved drug for the prophylaxis of organ rejection in de novo kidney transplant patients or in kidney transplant patients converted from IR tacrolimus when used with other immunosuppressants. Envarsus XR is a novel extended-release formulation of tacrolimus created using MeltDose technology. Envarsus XR is available in tablet form. It is available in 0.75, 1, and 4 mg tablets.
|
IR Tacrolimus (Historical Control)
Historical cohort of patients maintained on IR tacrolimus following transplant. These patients were not enrolled in the trial as participants.
Immediate-Release Tacrolimus: Historical cohort of 20 subjects who will be maintained on IR tacrolimus following transplant. Dosing will be converted on an individual basis (Capsules: 0.5 mg, 1 mg and 5 mg or Injection: 5 mg) . All patients will be initiated on IR tacrolimus either under the tongue (sublingual) or as a solution given through a tube placed through the nose into the stomach, which is standard of care for all lung transplant recipients.
|
|---|---|---|
|
Percentage of Patients Remaining on Envarsus XR at 1 Year
|
40 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 1 Year Post-TransplantNumber of participants who did not experience ACR as of the 1-year follow-up.
Outcome measures
| Measure |
Envarsus XR
n=40 Participants
Envarsus XR to be initiated once patient is tolerating oral medications
Extended-Release Tacrolimus: Envarsus XR is an FDA-approved drug for the prophylaxis of organ rejection in de novo kidney transplant patients or in kidney transplant patients converted from IR tacrolimus when used with other immunosuppressants. Envarsus XR is a novel extended-release formulation of tacrolimus created using MeltDose technology. Envarsus XR is available in tablet form. It is available in 0.75, 1, and 4 mg tablets.
|
IR Tacrolimus (Historical Control)
n=24 Participants
Historical cohort of patients maintained on IR tacrolimus following transplant. These patients were not enrolled in the trial as participants.
Immediate-Release Tacrolimus: Historical cohort of 20 subjects who will be maintained on IR tacrolimus following transplant. Dosing will be converted on an individual basis (Capsules: 0.5 mg, 1 mg and 5 mg or Injection: 5 mg) . All patients will be initiated on IR tacrolimus either under the tongue (sublingual) or as a solution given through a tube placed through the nose into the stomach, which is standard of care for all lung transplant recipients.
|
|---|---|---|
|
Freedom From Acute Cellular Rejection (ACR) at 1 Year
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 1 Year Post-TransplantThe CRSS is a novel measure of burden of ACR. The score ranges from 0-6; higher scores indicate greater severity of burden of ACR.
Outcome measures
| Measure |
Envarsus XR
n=40 Participants
Envarsus XR to be initiated once patient is tolerating oral medications
Extended-Release Tacrolimus: Envarsus XR is an FDA-approved drug for the prophylaxis of organ rejection in de novo kidney transplant patients or in kidney transplant patients converted from IR tacrolimus when used with other immunosuppressants. Envarsus XR is a novel extended-release formulation of tacrolimus created using MeltDose technology. Envarsus XR is available in tablet form. It is available in 0.75, 1, and 4 mg tablets.
|
IR Tacrolimus (Historical Control)
n=24 Participants
Historical cohort of patients maintained on IR tacrolimus following transplant. These patients were not enrolled in the trial as participants.
Immediate-Release Tacrolimus: Historical cohort of 20 subjects who will be maintained on IR tacrolimus following transplant. Dosing will be converted on an individual basis (Capsules: 0.5 mg, 1 mg and 5 mg or Injection: 5 mg) . All patients will be initiated on IR tacrolimus either under the tongue (sublingual) or as a solution given through a tube placed through the nose into the stomach, which is standard of care for all lung transplant recipients.
|
|---|---|---|
|
Composite Rejection Standardized Score (CRSS)
|
0.19 score on a scale
Standard Deviation 0.37
|
0.33 score on a scale
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: Up to 1 Year Post-TransplantNumber of participants with treated episodes of biopsy-proven or clinically suspected rejection requiring treatment with intravenous methylprednisolone or anti-thymocyte globulin.
Outcome measures
| Measure |
Envarsus XR
n=40 Participants
Envarsus XR to be initiated once patient is tolerating oral medications
Extended-Release Tacrolimus: Envarsus XR is an FDA-approved drug for the prophylaxis of organ rejection in de novo kidney transplant patients or in kidney transplant patients converted from IR tacrolimus when used with other immunosuppressants. Envarsus XR is a novel extended-release formulation of tacrolimus created using MeltDose technology. Envarsus XR is available in tablet form. It is available in 0.75, 1, and 4 mg tablets.
|
IR Tacrolimus (Historical Control)
n=24 Participants
Historical cohort of patients maintained on IR tacrolimus following transplant. These patients were not enrolled in the trial as participants.
Immediate-Release Tacrolimus: Historical cohort of 20 subjects who will be maintained on IR tacrolimus following transplant. Dosing will be converted on an individual basis (Capsules: 0.5 mg, 1 mg and 5 mg or Injection: 5 mg) . All patients will be initiated on IR tacrolimus either under the tongue (sublingual) or as a solution given through a tube placed through the nose into the stomach, which is standard of care for all lung transplant recipients.
|
|---|---|---|
|
Number of Treated Episodes of ACR
|
8 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 1 Year Post-TransplantNumber of participants with at least 1 instance of CLAD.
Outcome measures
| Measure |
Envarsus XR
n=40 Participants
Envarsus XR to be initiated once patient is tolerating oral medications
Extended-Release Tacrolimus: Envarsus XR is an FDA-approved drug for the prophylaxis of organ rejection in de novo kidney transplant patients or in kidney transplant patients converted from IR tacrolimus when used with other immunosuppressants. Envarsus XR is a novel extended-release formulation of tacrolimus created using MeltDose technology. Envarsus XR is available in tablet form. It is available in 0.75, 1, and 4 mg tablets.
|
IR Tacrolimus (Historical Control)
n=24 Participants
Historical cohort of patients maintained on IR tacrolimus following transplant. These patients were not enrolled in the trial as participants.
Immediate-Release Tacrolimus: Historical cohort of 20 subjects who will be maintained on IR tacrolimus following transplant. Dosing will be converted on an individual basis (Capsules: 0.5 mg, 1 mg and 5 mg or Injection: 5 mg) . All patients will be initiated on IR tacrolimus either under the tongue (sublingual) or as a solution given through a tube placed through the nose into the stomach, which is standard of care for all lung transplant recipients.
|
|---|---|---|
|
Number of Participants With of Chronic Lung Allograft Dysfunction (CLAD)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 1 Year Post-TransplantNumber of individuals in whom an antibody is detected after transplantation.
Outcome measures
| Measure |
Envarsus XR
n=40 Participants
Envarsus XR to be initiated once patient is tolerating oral medications
Extended-Release Tacrolimus: Envarsus XR is an FDA-approved drug for the prophylaxis of organ rejection in de novo kidney transplant patients or in kidney transplant patients converted from IR tacrolimus when used with other immunosuppressants. Envarsus XR is a novel extended-release formulation of tacrolimus created using MeltDose technology. Envarsus XR is available in tablet form. It is available in 0.75, 1, and 4 mg tablets.
|
IR Tacrolimus (Historical Control)
n=24 Participants
Historical cohort of patients maintained on IR tacrolimus following transplant. These patients were not enrolled in the trial as participants.
Immediate-Release Tacrolimus: Historical cohort of 20 subjects who will be maintained on IR tacrolimus following transplant. Dosing will be converted on an individual basis (Capsules: 0.5 mg, 1 mg and 5 mg or Injection: 5 mg) . All patients will be initiated on IR tacrolimus either under the tongue (sublingual) or as a solution given through a tube placed through the nose into the stomach, which is standard of care for all lung transplant recipients.
|
|---|---|---|
|
Number of Participants With De Novo Donor-Specific Antibody (DSA)
|
19 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline, 1 Year Post-TransplantChange in Estimated Glomerular Filtration Rate (eGFR) at 1 year post-transplant from pre-transplant.
Outcome measures
| Measure |
Envarsus XR
n=40 Participants
Envarsus XR to be initiated once patient is tolerating oral medications
Extended-Release Tacrolimus: Envarsus XR is an FDA-approved drug for the prophylaxis of organ rejection in de novo kidney transplant patients or in kidney transplant patients converted from IR tacrolimus when used with other immunosuppressants. Envarsus XR is a novel extended-release formulation of tacrolimus created using MeltDose technology. Envarsus XR is available in tablet form. It is available in 0.75, 1, and 4 mg tablets.
|
IR Tacrolimus (Historical Control)
n=24 Participants
Historical cohort of patients maintained on IR tacrolimus following transplant. These patients were not enrolled in the trial as participants.
Immediate-Release Tacrolimus: Historical cohort of 20 subjects who will be maintained on IR tacrolimus following transplant. Dosing will be converted on an individual basis (Capsules: 0.5 mg, 1 mg and 5 mg or Injection: 5 mg) . All patients will be initiated on IR tacrolimus either under the tongue (sublingual) or as a solution given through a tube placed through the nose into the stomach, which is standard of care for all lung transplant recipients.
|
|---|---|---|
|
Change in Estimated Glomerular Filtration Rate (eGFR)
|
-56.2 mL/min/1.73m2
Standard Deviation 27.1
|
-40.3 mL/min/1.73m2
Standard Deviation 21.2
|
SECONDARY outcome
Timeframe: 1 Year Post-TransplantThe percentage of participants who are alive at 1 year post-transplant.
Outcome measures
| Measure |
Envarsus XR
n=40 Participants
Envarsus XR to be initiated once patient is tolerating oral medications
Extended-Release Tacrolimus: Envarsus XR is an FDA-approved drug for the prophylaxis of organ rejection in de novo kidney transplant patients or in kidney transplant patients converted from IR tacrolimus when used with other immunosuppressants. Envarsus XR is a novel extended-release formulation of tacrolimus created using MeltDose technology. Envarsus XR is available in tablet form. It is available in 0.75, 1, and 4 mg tablets.
|
IR Tacrolimus (Historical Control)
n=24 Participants
Historical cohort of patients maintained on IR tacrolimus following transplant. These patients were not enrolled in the trial as participants.
Immediate-Release Tacrolimus: Historical cohort of 20 subjects who will be maintained on IR tacrolimus following transplant. Dosing will be converted on an individual basis (Capsules: 0.5 mg, 1 mg and 5 mg or Injection: 5 mg) . All patients will be initiated on IR tacrolimus either under the tongue (sublingual) or as a solution given through a tube placed through the nose into the stomach, which is standard of care for all lung transplant recipients.
|
|---|---|---|
|
Overall Survival at 1 Year
|
100 Percentage of participants
|
100 Percentage of participants
|
Adverse Events
Envarsus XR
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
Historical Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Envarsus XR
n=40 participants at risk
Envarsus XR to be initiated once patient is tolerating oral medications
Extended-Release Tacrolimus: Envarsus XR is an FDA-approved drug for the prophylaxis of organ rejection in de novo kidney transplant patients or in kidney transplant patients converted from IR tacrolimus when used with other immunosuppressants. Envarsus XR is a novel extended-release formulation of tacrolimus created using MeltDose technology. Envarsus XR is available in tablet form. It is available in 0.75, 1, and 4 mg tablets.
|
Historical Controls
Historical cohort of patients maintained on IR tacrolimus following transplant. These patients were not enrolled in the trial as participants.
Immediate-Release Tacrolimus: Historical cohort of 20 subjects who will be maintained on IR tacrolimus following transplant. Dosing will be converted on an individual basis (Capsules: 0.5 mg, 1 mg and 5 mg or Injection: 5 mg) . All patients will be initiated on IR tacrolimus either under the tongue (sublingual) or as a solution given through a tube placed through the nose into the stomach, which is standard of care for all lung transplant recipients.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Allograft failure
|
2.5%
1/40 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
—
0/0 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
Other adverse events
| Measure |
Envarsus XR
n=40 participants at risk
Envarsus XR to be initiated once patient is tolerating oral medications
Extended-Release Tacrolimus: Envarsus XR is an FDA-approved drug for the prophylaxis of organ rejection in de novo kidney transplant patients or in kidney transplant patients converted from IR tacrolimus when used with other immunosuppressants. Envarsus XR is a novel extended-release formulation of tacrolimus created using MeltDose technology. Envarsus XR is available in tablet form. It is available in 0.75, 1, and 4 mg tablets.
|
Historical Controls
Historical cohort of patients maintained on IR tacrolimus following transplant. These patients were not enrolled in the trial as participants.
Immediate-Release Tacrolimus: Historical cohort of 20 subjects who will be maintained on IR tacrolimus following transplant. Dosing will be converted on an individual basis (Capsules: 0.5 mg, 1 mg and 5 mg or Injection: 5 mg) . All patients will be initiated on IR tacrolimus either under the tongue (sublingual) or as a solution given through a tube placed through the nose into the stomach, which is standard of care for all lung transplant recipients.
|
|---|---|---|
|
Infections and infestations
Sepsis/pneumonia
|
20.0%
8/40 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
—
0/0 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
|
Injury, poisoning and procedural complications
Acute rejection
|
22.5%
9/40 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
—
0/0 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
|
Gastrointestinal disorders
Nausea/vomiting/diarrhea
|
17.5%
7/40 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
—
0/0 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
|
Infections and infestations
Respiratory viral infection
|
12.5%
5/40 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
—
0/0 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
|
Metabolism and nutrition disorders
Hyperglycemia/Hyperosmolar hyperglycemic state (HHS)/Diabetic ketoacidosis (DKA)
|
7.5%
3/40 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
—
0/0 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.0%
2/40 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
—
0/0 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
|
Surgical and medical procedures
Video-assisted thoracoscopic surgery (VATS) pleurodesis
|
5.0%
2/40 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
—
0/0 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
|
Infections and infestations
Cytomegalovirus (CMV) infection
|
5.0%
2/40 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
—
0/0 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
|
Injury, poisoning and procedural complications
Antibody-mediated rejection
|
5.0%
2/40 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
—
0/0 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion/thoracentesis
|
5.0%
2/40 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
—
0/0 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
|
Gastrointestinal disorders
Diverticulitis
|
5.0%
2/40 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
—
0/0 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
|
Psychiatric disorders
Anxiety attack
|
2.5%
1/40 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
—
0/0 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
|
Infections and infestations
Mycobacterium avium-intracellulare (MAI) infection
|
2.5%
1/40 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
—
0/0 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
|
Nervous system disorders
Peripheral neuropathy/pain
|
2.5%
1/40 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
—
0/0 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
|
Respiratory, thoracic and mediastinal disorders
Hemothorax
|
2.5%
1/40 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
—
0/0 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
|
Infections and infestations
Sinusitis
|
2.5%
1/40 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
—
0/0 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
|
Renal and urinary disorders
Ureterostomy
|
2.5%
1/40 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
—
0/0 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.5%
1/40 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
—
0/0 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
|
Respiratory, thoracic and mediastinal disorders
Dysphagia/aspiration
|
2.5%
1/40 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
—
0/0 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
|
Vascular disorders
Hypotension/syncope
|
2.5%
1/40 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
—
0/0 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
|
Cardiac disorders
Pericarditis
|
2.5%
1/40 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
—
0/0 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
|
Injury, poisoning and procedural complications
Drug overdose
|
2.5%
1/40 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
—
0/0 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
|
Cardiac disorders
Arrhythmia
|
2.5%
1/40 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
—
0/0 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
|
Infections and infestations
Aspergillus infection
|
2.5%
1/40 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
—
0/0 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
|
Renal and urinary disorders
Acute kidney injury
|
2.5%
1/40 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
—
0/0 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
|
Injury, poisoning and procedural complications
Hemoptysis after transbronchial biopsy
|
2.5%
1/40 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
—
0/0 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
|
Respiratory, thoracic and mediastinal disorders
Cough/shortness of breath
|
2.5%
1/40 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
—
0/0 • 2 years.
Adverse events were assessed through regular investigator assessment and laboratory testing in the Envarsus XR group only. Adverse event data (adverse event/serious adverse events) were not collected from/assessed in the Historical Control group. All-cause mortality was assessed in both groups, via the outcome measure "Overall Survival."
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place