Trial Outcomes & Findings for A Study of INCMGA00012 in Participants With Selected Solid Tumors (POD1UM-203) (NCT NCT03679767)
NCT ID: NCT03679767
Last Updated: 2023-07-21
Results Overview
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1), as determined by the investigator, at any post-Baseline visit until new anti-cancer therapy or first Progressive Disease. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
121 participants
Primary outcome timeframe
up to 25.9 months
Results posted on
2023-07-21
Participant Flow
This study was conducted at 34 study centers in Austria, Spain, France, Hungary, Italy, Poland, Romania, and the United States.
A total of 121 participants with advanced solid tumors (melanoma, non-small cell lung cancer, urethelial carcinoma, and renal cell carcinoma) were enrolled in the study and treated with retifanlimab.
Participant milestones
| Measure |
Melanoma
Participants with melanoma received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle (Q4W).
|
Non-small Cell Lung Cancer
Participants with non-small cell lung cancer received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Urethelial Carcinoma
Participants with urethelial carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Renal Cell Carcinoma
Participants with renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
35
|
23
|
29
|
34
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
35
|
23
|
29
|
34
|
Reasons for withdrawal
| Measure |
Melanoma
Participants with melanoma received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle (Q4W).
|
Non-small Cell Lung Cancer
Participants with non-small cell lung cancer received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Urethelial Carcinoma
Participants with urethelial carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Renal Cell Carcinoma
Participants with renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
|---|---|---|---|---|
|
Overall Study
Death
|
16
|
11
|
17
|
10
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
Overall Study
Follow-up Completed
|
18
|
11
|
11
|
20
|
|
Overall Study
Entered Hospice Care
|
0
|
0
|
0
|
1
|
|
Overall Study
Progressive Disease
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of INCMGA00012 in Participants With Selected Solid Tumors (POD1UM-203)
Baseline characteristics by cohort
| Measure |
Melanoma
n=35 Participants
Participants with melanoma received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle (Q4W).
|
Non-small Cell Lung Cancer
n=23 Participants
Participants with non-small cell lung cancer received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Urethelial Carcinoma
n=29 Participants
Participants with urethelial carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Renal Cell Carcinoma
n=34 Participants
Participants with renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
67.2 Years
STANDARD_DEVIATION 15.24 • n=5 Participants
|
67.8 Years
STANDARD_DEVIATION 8.68 • n=7 Participants
|
72.0 Years
STANDARD_DEVIATION 8.23 • n=5 Participants
|
66.6 Years
STANDARD_DEVIATION 10.28 • n=4 Participants
|
68.3 Years
STANDARD_DEVIATION 11.36 • n=21 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
35 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
110 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
93 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: up to 25.9 monthsPopulation: Full Analysis Set (FAS) Population: all study participants who had received at least 1 dose of study drug. Participants were to be analyzed based on disease-specific diagnosis. Confidence intervals were calculated based on the exact method for binomial distributions.
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1), as determined by the investigator, at any post-Baseline visit until new anti-cancer therapy or first Progressive Disease. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Outcome measures
| Measure |
Melanoma
n=35 Participants
Participants with melanoma received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle (Q4W).
|
Non-small Cell Lung Cancer
n=23 Participants
Participants with non-small cell lung cancer received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Urethelial Carcinoma
n=29 Participants
Participants with urethelial carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Renal Cell Carcinoma
n=34 Participants
Participants with renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
|---|---|---|---|---|
|
Overall Response Rate (ORR)
|
40.0 percentage of participants
Interval 23.9 to 57.9
|
34.8 percentage of participants
Interval 16.4 to 57.3
|
37.9 percentage of participants
Interval 20.7 to 57.7
|
23.5 percentage of participants
Interval 10.7 to 41.2
|
SECONDARY outcome
Timeframe: up to 24.0 monthsPopulation: FAS Population. Only those participants with a CR or PR were included in the analysis. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method and Klein and Moeschberger's method with log-log transformation.
DOR was defined as the time from initial objective response (CR or PR) per RECIST v1.1 until the first observation of documented disease progression (PD), as determined by the investigator, or death due to any cause. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.
Outcome measures
| Measure |
Melanoma
n=14 Participants
Participants with melanoma received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle (Q4W).
|
Non-small Cell Lung Cancer
n=8 Participants
Participants with non-small cell lung cancer received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Urethelial Carcinoma
n=11 Participants
Participants with urethelial carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Renal Cell Carcinoma
n=8 Participants
Participants with renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
|---|---|---|---|---|
|
Duration of Response (DOR)
|
NA months
Interval 9.2 to
The median and upper limit of the confidence interval were not estimable because too few participants had events of disease progression or death.
|
18.2 months
Interval 1.9 to
The upper limit of the confidence interval was not estimable because too few participants had events of disease progression or death.
|
11.5 months
Interval 2.2 to
The upper limit of the confidence interval was not estimable because too few participants had events of disease progression or death.
|
NA months
Interval 2.8 to
The median and upper limit of the confidence interval were not estimable because too few participants had events of disease progression or death
|
SECONDARY outcome
Timeframe: up to 25.9 monthsPopulation: FAS Population. Confidence intervals were calculated based on the exact method for binomial distributions.
DCR was defined as the proportion of participants with an overall response of CR, PR, or stable disease (SD), per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Outcome measures
| Measure |
Melanoma
n=35 Participants
Participants with melanoma received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle (Q4W).
|
Non-small Cell Lung Cancer
n=23 Participants
Participants with non-small cell lung cancer received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Urethelial Carcinoma
n=29 Participants
Participants with urethelial carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Renal Cell Carcinoma
n=34 Participants
Participants with renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
|---|---|---|---|---|
|
Disease Control Rate (DCR)
|
54.3 percentage of participants
Interval 36.6 to 71.2
|
65.2 percentage of participants
Interval 42.7 to 83.6
|
55.2 percentage of participants
Interval 35.7 to 73.6
|
64.7 percentage of participants
Interval 46.5 to 80.3
|
SECONDARY outcome
Timeframe: up to 25.9 monthsPopulation: FAS Population. Median PFS was estimated using the Kaplan-Meier method. The confidence interval for median PFS was calculated using the method of Brookmeyer and Crowley.
According to RECIST 1.1, PFS was defined as the length of time from the initial infusion of study drug until the earliest date of disease progression, determined by investigator assessment, or death due to any cause, if occurring sooner than progression.
Outcome measures
| Measure |
Melanoma
n=35 Participants
Participants with melanoma received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle (Q4W).
|
Non-small Cell Lung Cancer
n=23 Participants
Participants with non-small cell lung cancer received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Urethelial Carcinoma
n=29 Participants
Participants with urethelial carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Renal Cell Carcinoma
n=34 Participants
Participants with renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
|---|---|---|---|---|
|
Progression-free Survival (PFS)
|
3.6 months
Interval 1.8 to
The upper limit of the confidence interval was not estimable because too few participants had events of disease progression or death.
|
4.4 months
Interval 1.8 to 21.9
|
5.7 months
Interval 1.8 to 13.6
|
5.4 months
Interval 2.3 to 11.4
|
SECONDARY outcome
Timeframe: up to 28.2 monthsPopulation: FAS Population. Median survival time in months was estimated using the Kaplan-Meier method. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.
Overall survival was defined as the time in months between the first dose date (Day 1) and the date of death due to any cause.
Outcome measures
| Measure |
Melanoma
n=35 Participants
Participants with melanoma received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle (Q4W).
|
Non-small Cell Lung Cancer
n=23 Participants
Participants with non-small cell lung cancer received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Urethelial Carcinoma
n=29 Participants
Participants with urethelial carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Renal Cell Carcinoma
n=34 Participants
Participants with renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
|---|---|---|---|---|
|
Overall Survival
|
NA months
Interval 8.7 to
The median and the upper limit of the confidence interval were not estimable because too few participants had events of death.
|
21.9 months
Interval 5.2 to
The upper limit of the confidence interval was not estimable because too few participants had events of death.
|
15.2 months
Interval 7.7 to
The upper limit of the confidence interval was not estimable because too few participants had events of death.
|
NA months
The median and the upper and lower limits of the confidence interval were not estimable because too few participants had events of death.
|
SECONDARY outcome
Timeframe: up to approximately 2.3 yearsPopulation: Safety Evaluable Population: all participants who received at least 1 dose of study drug
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
Outcome measures
| Measure |
Melanoma
n=35 Participants
Participants with melanoma received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle (Q4W).
|
Non-small Cell Lung Cancer
n=23 Participants
Participants with non-small cell lung cancer received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Urethelial Carcinoma
n=29 Participants
Participants with urethelial carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Renal Cell Carcinoma
n=34 Participants
Participants with renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
32 Participants
|
21 Participants
|
28 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1Population: Pharmacokinetic (PK) Evaluable Population: all participants who received at least 1 dose of study drug and provided a Baseline and at least 1 postdose PK sample
Cmax was defined as the maximum observed plasma or serum concentration of retifanlimab.
Outcome measures
| Measure |
Melanoma
n=121 Participants
Participants with melanoma received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle (Q4W).
|
Non-small Cell Lung Cancer
Participants with non-small cell lung cancer received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Urethelial Carcinoma
Participants with urethelial carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Renal Cell Carcinoma
Participants with renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
|---|---|---|---|---|
|
First-dose Cmax of Retifanlimab
|
143 milligrams per Liter (mg/L)
Standard Deviation 30.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycles 1, 2, 4, and 6 (up to approximately 168 days; each cycle was 28 days)Population: PK Evaluable Population
Cmax was defined as the maximum observed plasma or serum concentration of retifanlimab.
Outcome measures
| Measure |
Melanoma
n=121 Participants
Participants with melanoma received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle (Q4W).
|
Non-small Cell Lung Cancer
Participants with non-small cell lung cancer received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Urethelial Carcinoma
Participants with urethelial carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Renal Cell Carcinoma
Participants with renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
|---|---|---|---|---|
|
Cmax of Retifanlimab at Steady-state
|
181 mg/L
Standard Deviation 39.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1Population: PK Evaluable Population
tmax was defined as the time to the maximum concentration of retifanlimab.
Outcome measures
| Measure |
Melanoma
n=121 Participants
Participants with melanoma received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle (Q4W).
|
Non-small Cell Lung Cancer
Participants with non-small cell lung cancer received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Urethelial Carcinoma
Participants with urethelial carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Renal Cell Carcinoma
Participants with renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
|---|---|---|---|---|
|
First-dose Tmax of Retifanlimab
|
0.500 hours
Interval 0.5 to 1.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycles 1, 2, 4, and 6 (up to approximately 168 days; each cycle was 28 days)Population: PK Evaluable Population
tmax was defined as the time to the maximum concentration of retifanlimab.
Outcome measures
| Measure |
Melanoma
n=121 Participants
Participants with melanoma received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle (Q4W).
|
Non-small Cell Lung Cancer
Participants with non-small cell lung cancer received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Urethelial Carcinoma
Participants with urethelial carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Renal Cell Carcinoma
Participants with renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
|---|---|---|---|---|
|
Tmax of Retifanlimab at Steady-state
|
0.500 hours
Interval 0.5 to 1.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1Population: PK Evaluable Population
Cmin was defined as the minimum observed plasma or serum concentration over the dose interval of retifanlimab.
Outcome measures
| Measure |
Melanoma
n=121 Participants
Participants with melanoma received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle (Q4W).
|
Non-small Cell Lung Cancer
Participants with non-small cell lung cancer received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Urethelial Carcinoma
Participants with urethelial carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Renal Cell Carcinoma
Participants with renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
|---|---|---|---|---|
|
First-dose Cmin of Retifanlimab
|
18.0 mg/L
Standard Deviation 7.52
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycles 1, 2, 4, and 6 (up to approximately 168 days; each cycle was 28 days)Population: PK Evaluable Population
Cmin was defined as the minimum observed plasma or serum concentration over the dose interval of retifanlimab.
Outcome measures
| Measure |
Melanoma
n=121 Participants
Participants with melanoma received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle (Q4W).
|
Non-small Cell Lung Cancer
Participants with non-small cell lung cancer received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Urethelial Carcinoma
Participants with urethelial carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Renal Cell Carcinoma
Participants with renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
|---|---|---|---|---|
|
Cmin of Retifanlimabv at Steady-state
|
38.2 mg/L
Standard Deviation 16.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1Population: PK Evaluable Population
AUC0-t was defined as the area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t of retifanlimab.
Outcome measures
| Measure |
Melanoma
n=121 Participants
Participants with melanoma received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle (Q4W).
|
Non-small Cell Lung Cancer
Participants with non-small cell lung cancer received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Urethelial Carcinoma
Participants with urethelial carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Renal Cell Carcinoma
Participants with renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
|---|---|---|---|---|
|
First-dose AUC0-t of Retifanlimab
|
1620 day*mg/L
Standard Deviation 506
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycles 1, 2, 4, and 6 (up to approximately 168 days; each cycle was 28 days)Population: PK Evaluable Population
AUC0-t was defined as the area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t of retifanlimab.
Outcome measures
| Measure |
Melanoma
n=121 Participants
Participants with melanoma received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle (Q4W).
|
Non-small Cell Lung Cancer
Participants with non-small cell lung cancer received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Urethelial Carcinoma
Participants with urethelial carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Renal Cell Carcinoma
Participants with renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
|---|---|---|---|---|
|
AUC0-t of Retifanlimab at Steady-state
|
2030 day*mg/L
Standard Deviation 566
|
—
|
—
|
—
|
Adverse Events
Melanoma
Serious events: 8 serious events
Other events: 30 other events
Deaths: 16 deaths
Non-small Cell Lung Cancer
Serious events: 9 serious events
Other events: 19 other events
Deaths: 11 deaths
Urothelial Cancer
Serious events: 12 serious events
Other events: 25 other events
Deaths: 17 deaths
Renal Cell Carcinoma
Serious events: 11 serious events
Other events: 30 other events
Deaths: 10 deaths
Total
Serious events: 40 serious events
Other events: 104 other events
Deaths: 54 deaths
Serious adverse events
| Measure |
Melanoma
n=35 participants at risk
Participants with melanoma received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle (Q4W).
|
Non-small Cell Lung Cancer
n=23 participants at risk
Participants with non-small cell lung cancer received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Urothelial Cancer
n=29 participants at risk
Participants with urethelial carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Renal Cell Carcinoma
n=34 participants at risk
Participants with renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Total
n=121 participants at risk
Total
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
3.4%
1/29 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.9%
1/35 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.9%
1/34 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.9%
1/34 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
General disorders
Asthenia
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
3.4%
1/29 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Musculoskeletal and connective tissue disorders
Bone lesion
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.9%
1/34 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.9%
1/34 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Infections and infestations
COVID-19 pneumonia
|
2.9%
1/35 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
1.7%
2/121 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Infections and infestations
Cellulitis
|
2.9%
1/35 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
3.4%
1/29 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
General disorders
Chills
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.9%
1/34 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
5.7%
2/35 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
8.7%
2/23 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
3.3%
4/121 • Number of events 4 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Nervous system disorders
Cognitive disorder
|
2.9%
1/35 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
General disorders
Death
|
2.9%
1/35 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
3.4%
1/29 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.9%
1/34 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.9%
1/34 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
General disorders
General physical health deterioration
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
3.4%
1/29 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.9%
1/34 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
6.9%
2/29 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
1.7%
2/121 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
3.4%
1/29 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.9%
1/35 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.9%
1/34 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Vascular disorders
Hypertensive crisis
|
2.9%
1/35 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
General disorders
Hyperthermia
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
3.4%
1/29 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.9%
1/34 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.9%
1/34 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Infections and infestations
Infection
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.9%
1/34 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.9%
1/34 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
3.4%
1/29 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Infections and infestations
Orchitis
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.9%
1/34 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Cardiac disorders
Paroxysmal atrioventricular block
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
3.4%
1/29 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
13.0%
3/23 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
8.8%
3/34 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
5.0%
6/121 • Number of events 6 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.9%
1/34 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
1.7%
2/121 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
General disorders
Pyrexia
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
3.4%
1/29 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
3.4%
1/29 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Infections and infestations
Sepsis
|
2.9%
1/35 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.9%
1/34 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.5%
3/121 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
3.4%
1/29 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.9%
1/34 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
3.4%
1/29 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
3.4%
1/29 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.83%
1/121 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
Other adverse events
| Measure |
Melanoma
n=35 participants at risk
Participants with melanoma received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle (Q4W).
|
Non-small Cell Lung Cancer
n=23 participants at risk
Participants with non-small cell lung cancer received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Urothelial Cancer
n=29 participants at risk
Participants with urethelial carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Renal Cell Carcinoma
n=34 participants at risk
Participants with renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.
|
Total
n=121 participants at risk
Total
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
1/35 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
10.3%
3/29 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.9%
1/34 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.1%
5/121 • Number of events 6 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.4%
4/35 • Number of events 4 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
3.4%
1/29 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.9%
1/34 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
5.0%
6/121 • Number of events 6 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Investigations
Alanine aminotransferase increased
|
2.9%
1/35 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
13.0%
3/23 • Number of events 4 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
3.4%
1/29 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
5.9%
2/34 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
5.8%
7/121 • Number of events 8 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Investigations
Amylase increased
|
2.9%
1/35 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
8.7%
2/23 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.5%
3/121 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Blood and lymphatic system disorders
Anaemia
|
5.7%
2/35 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
31.0%
9/29 • Number of events 9 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
14.7%
5/34 • Number of events 5 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
14.0%
17/121 • Number of events 17 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Psychiatric disorders
Anxiety
|
5.7%
2/35 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
8.7%
2/23 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.9%
1/34 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.1%
5/121 • Number of events 6 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.9%
8/35 • Number of events 10 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
27.6%
8/29 • Number of events 15 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
14.7%
5/34 • Number of events 13 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
17.4%
21/121 • Number of events 38 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
General disorders
Asthenia
|
20.0%
7/35 • Number of events 11 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
8.7%
2/23 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
31.0%
9/29 • Number of events 11 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
17.6%
6/34 • Number of events 7 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
19.8%
24/121 • Number of events 31 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
5.9%
2/34 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
1.7%
2/121 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.6%
3/35 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
13.8%
4/29 • Number of events 4 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
5.9%
2/34 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
8.3%
10/121 • Number of events 11 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
13.0%
3/23 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
3.4%
1/29 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
3.3%
4/121 • Number of events 4 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Investigations
Blood creatinine increased
|
2.9%
1/35 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
17.2%
5/29 • Number of events 5 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
5.9%
2/34 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
7.4%
9/121 • Number of events 10 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
6.9%
2/29 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
1.7%
2/121 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Infections and infestations
COVID-19
|
5.7%
2/35 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
1.7%
2/121 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
General disorders
Chills
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
6.9%
2/29 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.9%
1/34 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.5%
3/121 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
10.3%
3/29 • Number of events 4 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.5%
3/121 • Number of events 4 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Gastrointestinal disorders
Constipation
|
2.9%
1/35 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
8.7%
2/23 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
20.7%
6/29 • Number of events 9 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
14.7%
5/34 • Number of events 5 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
11.6%
14/121 • Number of events 17 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.4%
4/35 • Number of events 5 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
3.4%
1/29 • Number of events 4 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
11.8%
4/34 • Number of events 4 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
7.4%
9/121 • Number of events 13 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.4%
4/35 • Number of events 4 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
21.7%
5/23 • Number of events 5 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
24.1%
7/29 • Number of events 8 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
8.8%
3/34 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
15.7%
19/121 • Number of events 20 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
7/35 • Number of events 22 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
13.0%
3/23 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
17.2%
5/29 • Number of events 6 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
11.8%
4/34 • Number of events 7 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
15.7%
19/121 • Number of events 38 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Gastrointestinal disorders
Dry mouth
|
2.9%
1/35 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
3.4%
1/29 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
8.8%
3/34 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.1%
5/121 • Number of events 5 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.6%
3/35 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
6.9%
2/29 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
11.8%
4/34 • Number of events 5 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
8.3%
10/121 • Number of events 12 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.7%
2/35 • Number of events 4 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
13.0%
3/23 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
3.4%
1/29 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
17.6%
6/34 • Number of events 6 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
9.9%
12/121 • Number of events 14 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
8.6%
3/35 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.5%
3/121 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Renal and urinary disorders
Dysuria
|
5.7%
2/35 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
6.9%
2/29 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.9%
1/34 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.1%
5/121 • Number of events 5 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
13.0%
3/23 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
3.4%
1/29 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.9%
1/34 • Number of events 4 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.1%
5/121 • Number of events 8 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Investigations
Lipase increased
|
2.9%
1/35 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
5.9%
2/34 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.5%
3/121 • Number of events 4 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
General disorders
Fatigue
|
17.1%
6/35 • Number of events 7 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
8.7%
2/23 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
6.9%
2/29 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
5.9%
2/34 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
9.9%
12/121 • Number of events 13 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.7%
2/35 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
5.9%
2/34 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
3.3%
4/121 • Number of events 4 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
2.9%
1/35 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
6.9%
2/29 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.5%
3/121 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Renal and urinary disorders
Haematuria
|
2.9%
1/35 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
6.9%
2/29 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.5%
3/121 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
8.7%
2/23 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.9%
1/34 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.5%
3/121 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Nervous system disorders
Headache
|
20.0%
7/35 • Number of events 7 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.3%
1/23 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
3.4%
1/29 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
7.4%
9/121 • Number of events 10 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
6.9%
2/29 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
5.9%
2/34 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
3.3%
4/121 • Number of events 4 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.9%
1/35 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
3.4%
1/29 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
5.9%
2/34 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.1%
5/121 • Number of events 6 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Vascular disorders
Hypertension
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.3%
1/23 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
10.3%
3/29 • Number of events 4 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
5.9%
2/34 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
5.0%
6/121 • Number of events 8 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
5.9%
2/34 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.5%
3/121 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.9%
1/35 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
8.7%
2/23 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
3.4%
1/29 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
5.9%
2/34 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
5.0%
6/121 • Number of events 6 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Endocrine disorders
Hypothyroidism
|
14.3%
5/35 • Number of events 5 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
6.9%
2/29 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
8.8%
3/34 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
9.1%
11/121 • Number of events 11 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
3.4%
1/29 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
8.8%
3/34 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.1%
5/121 • Number of events 5 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
General disorders
Malaise
|
5.7%
2/35 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
3.4%
1/29 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.5%
3/121 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
5.9%
2/34 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
1.7%
2/121 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.7%
2/35 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
6.9%
2/29 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.9%
1/34 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
5.0%
6/121 • Number of events 6 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Infections and infestations
Nasopharyngitis
|
2.9%
1/35 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
5.9%
2/34 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.5%
3/121 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
5/35 • Number of events 5 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
13.8%
4/29 • Number of events 4 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
8.8%
3/34 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
9.9%
12/121 • Number of events 12 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.9%
1/35 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
6.9%
2/29 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.5%
3/121 • Number of events 4 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
General disorders
Oedema peripheral
|
2.9%
1/35 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
17.2%
5/29 • Number of events 5 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
8.8%
3/34 • Number of events 4 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
8.3%
10/121 • Number of events 11 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
General disorders
Pain
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
3.4%
1/29 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
5.9%
2/34 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.5%
3/121 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.7%
2/35 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
10.3%
3/29 • Number of events 5 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
5.9%
2/34 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
6.6%
8/121 • Number of events 10 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Nervous system disorders
Paraesthesia
|
8.6%
3/35 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
3.4%
1/29 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
11.8%
4/34 • Number of events 4 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
6.6%
8/121 • Number of events 8 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
6.9%
2/29 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
1.7%
2/121 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Infections and infestations
Pneumonia
|
2.9%
1/35 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
8.7%
2/23 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
11.8%
4/34 • Number of events 6 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
5.8%
7/121 • Number of events 9 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.7%
9/35 • Number of events 12 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
13.0%
3/23 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
13.8%
4/29 • Number of events 5 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
14.7%
5/34 • Number of events 5 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
17.4%
21/121 • Number of events 25 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
General disorders
Pyrexia
|
8.6%
3/35 • Number of events 6 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
8.7%
2/23 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
13.8%
4/29 • Number of events 7 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
11.8%
4/34 • Number of events 8 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
10.7%
13/121 • Number of events 23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
5/35 • Number of events 12 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
8.7%
2/23 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
10.3%
3/29 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
14.7%
5/34 • Number of events 5 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
12.4%
15/121 • Number of events 22 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
5.7%
2/35 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.9%
1/34 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.5%
3/121 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
5.9%
2/34 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
1.7%
2/121 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.7%
2/35 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.9%
1/34 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.5%
3/121 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
6.9%
2/29 • Number of events 4 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.9%
1/34 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.5%
3/121 • Number of events 5 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Infections and infestations
Skin infection
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
5.9%
2/34 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
1.7%
2/121 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
6.9%
2/29 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.9%
1/34 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.5%
3/121 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
5.9%
2/34 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.5%
3/121 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Gastrointestinal disorders
Toothache
|
5.7%
2/35 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
1.7%
2/121 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Infections and infestations
Urinary tract infection
|
8.6%
3/35 • Number of events 4 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
21.7%
5/23 • Number of events 6 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
13.8%
4/29 • Number of events 5 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
14.7%
5/34 • Number of events 6 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
14.0%
17/121 • Number of events 21 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/35 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
6.9%
2/29 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.9%
1/34 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.5%
3/121 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
5.7%
2/35 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/29 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/34 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
1.7%
2/121 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
2/35 • Number of events 3 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
6.9%
2/29 • Number of events 4 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
2.9%
1/34 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
5.0%
6/121 • Number of events 9 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
|
Investigations
Weight decreased
|
2.9%
1/35 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
0.00%
0/23 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
3.4%
1/29 • Number of events 1 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
5.9%
2/34 • Number of events 2 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
3.3%
4/121 • Number of events 4 • Adverse events were assessed for up to approximately 2.3 years. All-Cause Mortality was assessed for up to 28.2 months
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
- Publication restrictions are in place
Restriction type: OTHER