Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Andecaliximab Combined With Nivolumab Versus Nivolumab Alone in Adults With Unresectable or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma (NCT NCT02864381)
NCT ID: NCT02864381
Last Updated: 2020-09-18
Results Overview
ORR was defined as the percentage of participants with confirmed overall best response of complete response (CR) or partial response (PR) after starting study drug but before starting any new chemotherapy or radiotherapy as assessed by the investigator according to Response Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as the disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
144 participants
Primary outcome timeframe
Up to 41 weeks
Results posted on
2020-09-18
Participant Flow
Participants were enrolled at study sites in Australia, Europe, and the United States. The first participant was screened on 01 September 2016. The last study visit occurred on 23 August 2019.
187 participants were screened.
Participant milestones
| Measure |
Andecaliximab + Nivolumab
Andecaliximab 800 mg administered via intravenous (IV) infusion plus nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 34 weeks at the time of the primary efficacy analysis; up to 101 weeks at the time of the safety follow-up analysis).
|
Nivolumab
Nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 41 weeks at the time of the primary efficacy analysis; up to 97 weeks at the time of the safety follow-up analysis).
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
72
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
72
|
72
|
Reasons for withdrawal
| Measure |
Andecaliximab + Nivolumab
Andecaliximab 800 mg administered via intravenous (IV) infusion plus nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 34 weeks at the time of the primary efficacy analysis; up to 101 weeks at the time of the safety follow-up analysis).
|
Nivolumab
Nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 41 weeks at the time of the primary efficacy analysis; up to 97 weeks at the time of the safety follow-up analysis).
|
|---|---|---|
|
Overall Study
Death
|
58
|
61
|
|
Overall Study
Withdrew Consent
|
5
|
6
|
|
Overall Study
Reason Unknown
|
7
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Investigator's Discretion
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Study to Evaluate the Efficacy and Safety of Andecaliximab Combined With Nivolumab Versus Nivolumab Alone in Adults With Unresectable or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma
Baseline characteristics by cohort
| Measure |
Andecaliximab + Nivolumab
n=72 Participants
Andecaliximab 800 mg administered via intravenous (IV) infusion plus nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 34 weeks at the time of the primary efficacy analysis; up to 101 weeks at the time of the safety follow-up analysis).
|
Nivolumab
n=72 Participants
Nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 41 weeks at the time of the primary efficacy analysis; up to 97 weeks at the time of the safety follow-up analysis).
|
Total
n=144 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 12.1 • n=93 Participants
|
59 years
STANDARD_DEVIATION 11.8 • n=4 Participants
|
59 years
STANDARD_DEVIATION 11.9 • n=27 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=93 Participants
|
50 Participants
n=4 Participants
|
99 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
55 Participants
n=93 Participants
|
61 Participants
n=4 Participants
|
116 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Not Permitted
|
12 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
59 Participants
n=93 Participants
|
61 Participants
n=4 Participants
|
120 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Permitted
|
11 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Region of Enrollment
United Kingdom
|
17 participants
n=93 Participants
|
18 participants
n=4 Participants
|
35 participants
n=27 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=93 Participants
|
14 participants
n=4 Participants
|
28 participants
n=27 Participants
|
|
Region of Enrollment
Belgium
|
5 participants
n=93 Participants
|
10 participants
n=4 Participants
|
15 participants
n=27 Participants
|
|
Region of Enrollment
France
|
9 participants
n=93 Participants
|
6 participants
n=4 Participants
|
15 participants
n=27 Participants
|
|
Region of Enrollment
Poland
|
5 participants
n=93 Participants
|
9 participants
n=4 Participants
|
14 participants
n=27 Participants
|
|
Region of Enrollment
Spain
|
10 participants
n=93 Participants
|
4 participants
n=4 Participants
|
14 participants
n=27 Participants
|
|
Region of Enrollment
Italy
|
8 participants
n=93 Participants
|
5 participants
n=4 Participants
|
13 participants
n=27 Participants
|
|
Region of Enrollment
Australia
|
2 participants
n=93 Participants
|
5 participants
n=4 Participants
|
7 participants
n=27 Participants
|
|
Region of Enrollment
Hungary
|
2 participants
n=93 Participants
|
1 participants
n=4 Participants
|
3 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Up to 41 weeksPopulation: The Intent-to-treat Analysis Set included all participants who were randomized in the study.
ORR was defined as the percentage of participants with confirmed overall best response of complete response (CR) or partial response (PR) after starting study drug but before starting any new chemotherapy or radiotherapy as assessed by the investigator according to Response Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as the disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Andecaliximab + Nivolumab
n=72 Participants
Andecaliximab 800 mg administered via intravenous (IV) infusion plus nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 34 weeks at the time of the primary efficacy analysis; up to 101 weeks at the time of the safety follow-up analysis).
|
Nivolumab
n=72 Participants
Nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 41 weeks at the time of the primary efficacy analysis; up to 97 weeks at the time of the safety follow-up analysis).
|
|---|---|---|
|
Objective Response Rate (ORR)
|
9.7 percentage of participants
Interval 4.0 to 19.0
|
6.9 percentage of participants
Interval 2.3 to 15.5
|
SECONDARY outcome
Timeframe: Andecaliximab + Nivolumab median follow-up time: 7.0 months; Nivolumab median follow-up time: 7.1 monthsPopulation: Participants in the Intent-to-treat Analysis Set were analyzed.
PFS was defined as the interval in months from the date of randomization to the earlier of the first documentation of definitive disease progression or death from any cause. The first definitive progressive disease (PD) was defined as the first radiation therapy, the first clinical PD, and the first confirmed imaging PD, whichever came first. Participants without PD or death and participants with PD after starting new anti-cancer therapy are censored at the last tumor assessment date.
Outcome measures
| Measure |
Andecaliximab + Nivolumab
n=72 Participants
Andecaliximab 800 mg administered via intravenous (IV) infusion plus nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 34 weeks at the time of the primary efficacy analysis; up to 101 weeks at the time of the safety follow-up analysis).
|
Nivolumab
n=72 Participants
Nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 41 weeks at the time of the primary efficacy analysis; up to 97 weeks at the time of the safety follow-up analysis).
|
|---|---|---|
|
Progression Free Survival (PFS)
|
1.840 months
Interval 1.807 to 2.004
|
1.856 months
Interval 1.741 to 1.906
|
SECONDARY outcome
Timeframe: Andecaliximab + Nivolumab median follow-up time: 7.0 months; Nivolumab median follow-up time: 7.0 monthsPopulation: Participants in the Intent-to-treat Analysis Set were analyzed.
OS was defined as the interval from the date of randomization to death from any cause. Surviving participants are censored at the last date known alive.
Outcome measures
| Measure |
Andecaliximab + Nivolumab
n=72 Participants
Andecaliximab 800 mg administered via intravenous (IV) infusion plus nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 34 weeks at the time of the primary efficacy analysis; up to 101 weeks at the time of the safety follow-up analysis).
|
Nivolumab
n=72 Participants
Nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 41 weeks at the time of the primary efficacy analysis; up to 97 weeks at the time of the safety follow-up analysis).
|
|---|---|---|
|
Overall Survival (OS)
|
7.162 months
Interval 4.797 to
Upper 95% Confidence Interval was not reached due to the low number of participants with events.
|
5.881 months
Interval 3.483 to 10.908
|
SECONDARY outcome
Timeframe: Andecaliximab + Nivolumab median follow-up time: 7.0 months; Nivolumab median follow-up time: 7.1 monthsPopulation: Participants in the Intent-to-treat Analysis Set who achieved CR or PR were analyzed.
DOR was defined as the interval from the date of the first response (complete or partial response) was achieved to the earlier of the first documentation of definitive disease progression or death from any cause.
Outcome measures
| Measure |
Andecaliximab + Nivolumab
n=7 Participants
Andecaliximab 800 mg administered via intravenous (IV) infusion plus nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 34 weeks at the time of the primary efficacy analysis; up to 101 weeks at the time of the safety follow-up analysis).
|
Nivolumab
n=5 Participants
Nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 41 weeks at the time of the primary efficacy analysis; up to 97 weeks at the time of the safety follow-up analysis).
|
|---|---|---|
|
Duration of Response (DOR)
|
NA months
Interval 1.807 to
Median and Upper Limit of Confidence Interval (CI) were not estimable due to the low number of participants with events.
|
NA months
Interval 2.037 to
Median and Upper Limit of CI were not estimable due to the low number of participants with events.
|
SECONDARY outcome
Timeframe: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 monthsPopulation: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
An adverse event (AE) is any untoward medical occurrence in a clinical study participants administered a medicinal product, which does not necessarily have a causal relationship with the treatment. TEAEs are events that are defined as AEs with onset dates on or after the first dose of andecaliximab/nivolumab and up to 30 days after permanent discontinuation of andecaliximab or 5 months after permanent discontinuation of nivolumab, or led to premature discontinuation of andecaliximab or nivolumab.
Outcome measures
| Measure |
Andecaliximab + Nivolumab
n=71 Participants
Andecaliximab 800 mg administered via intravenous (IV) infusion plus nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 34 weeks at the time of the primary efficacy analysis; up to 101 weeks at the time of the safety follow-up analysis).
|
Nivolumab
n=70 Participants
Nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 41 weeks at the time of the primary efficacy analysis; up to 97 weeks at the time of the safety follow-up analysis).
|
|---|---|---|
|
Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
|
98.6 percentage of participants
|
97.1 percentage of participants
|
SECONDARY outcome
Timeframe: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 monthsPopulation: Participants in the Safety Analysis Set with available data were analyzed.
Treatment-emergent (Chemistry, Hematology, Coagulation, and Urinalysis) laboratory abnormalities were graded per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 where: 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Potentially Life Threatening. Treatment-emergent laboratory abnormalities are defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of the last dose of andecaliximab plus 30 days or nivolumab plus 5 months. If the relevant baseline laboratory value is missing, any abnormality of at least Grade 1 observed within the time frame specified above will be considered treatment-emergent. Percentage of participants with any postbaseline Grade 1 or higher laboratory abnormality is reported.
Outcome measures
| Measure |
Andecaliximab + Nivolumab
n=71 Participants
Andecaliximab 800 mg administered via intravenous (IV) infusion plus nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 34 weeks at the time of the primary efficacy analysis; up to 101 weeks at the time of the safety follow-up analysis).
|
Nivolumab
n=70 Participants
Nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 41 weeks at the time of the primary efficacy analysis; up to 97 weeks at the time of the safety follow-up analysis).
|
|---|---|---|
|
Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities
Alanine aminotransferase increased
|
20.0 percentage of participants
|
27.1 percentage of participants
|
|
Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities
Alkaline phosphatase increased
|
45.1 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities
Aspartate aminotransferase increased
|
30.0 percentage of participants
|
28.6 percentage of participants
|
|
Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities
Blood bilirubin increased
|
8.5 percentage of participants
|
11.4 percentage of participants
|
|
Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities
Chronic Kidney Disease
|
16.9 percentage of participants
|
25.7 percentage of participants
|
|
Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities
Creatinine increased
|
1.4 percentage of participants
|
7.1 percentage of participants
|
|
Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities
Hyperglycemia
|
22.5 percentage of participants
|
18.6 percentage of participants
|
|
Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities
Hyperkalemia
|
7.1 percentage of participants
|
5.7 percentage of participants
|
|
Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities
Hypermagnesemia
|
2.8 percentage of participants
|
1.4 percentage of participants
|
|
Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities
Hypoalbuminemia
|
35.2 percentage of participants
|
38.6 percentage of participants
|
|
Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities
Hypoglycemia
|
11.3 percentage of participants
|
4.3 percentage of participants
|
|
Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities
Hypokalemia
|
10.0 percentage of participants
|
11.4 percentage of participants
|
|
Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities
Hypomagnesemia
|
5.6 percentage of participants
|
4.3 percentage of participants
|
|
Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities
Hyponatremia
|
28.2 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities
Hypophosphatemia
|
11.3 percentage of participants
|
8.6 percentage of participants
|
|
Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities
Lipase increased
|
11.3 percentage of participants
|
8.6 percentage of participants
|
|
Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities
Serum amylase increased
|
9.9 percentage of participants
|
7.1 percentage of participants
|
|
Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities
Activated partial thromboplastin time prolonged
|
2.6 percentage of participants
|
19.4 percentage of participants
|
|
Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities
International Normalized Ratio (INR) increased
|
2.6 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities
Anemia
|
53.5 percentage of participants
|
56.5 percentage of participants
|
|
Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities
Lymphocytes, Typical count decreased
|
35.2 percentage of participants
|
27.5 percentage of participants
|
|
Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities
Lymphocytes, Typical count increased
|
4.2 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities
Neutrophil count decreased
|
5.6 percentage of participants
|
5.8 percentage of participants
|
|
Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities
Platelet count decreased
|
8.5 percentage of participants
|
5.8 percentage of participants
|
|
Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities
White blood cell decreased
|
9.9 percentage of participants
|
7.2 percentage of participants
|
|
Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities
Proteinuria (Dipstick)
|
29.4 percentage of participants
|
31.3 percentage of participants
|
Adverse Events
Andecaliximab + Nivolumab
Serious events: 42 serious events
Other events: 66 other events
Deaths: 61 deaths
Nivolumab
Serious events: 38 serious events
Other events: 62 other events
Deaths: 62 deaths
Serious adverse events
| Measure |
Andecaliximab + Nivolumab
n=71 participants at risk
Andecaliximab 800 mg administered via intravenous (IV) infusion plus nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 34 weeks at the time of the primary efficacy analysis; up to 101 weeks at the time of the safety follow-up analysis).
|
Nivolumab
n=70 participants at risk
Nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 41 weeks at the time of the primary efficacy analysis; up to 97 weeks at the time of the safety follow-up analysis).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.0%
5/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
4/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Endocrine disorders
Hypophysitis
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Eye disorders
Retinal disorder
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.2%
3/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.6%
6/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
4.2%
3/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
2/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
2.8%
2/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
5.6%
4/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
4/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastric perforation
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastric stenosis
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.3%
3/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.00%
0/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haematemesis
|
4.2%
3/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
5.6%
4/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intestinal perforation
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
2/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Melaena
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
4.2%
3/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
2/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
2/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.00%
0/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
4.2%
3/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
2.8%
2/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
4.2%
3/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Complication associated with device
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Euthanasia
|
0.00%
0/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
2/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
General physical health deterioration
|
0.00%
0/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
2/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
2.8%
2/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
2/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholangitis
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholestasis
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Jaundice
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Device related infection
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Infection
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Liver abscess
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Lung abscess
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
2.8%
2/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
2.8%
2/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Septic shock
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.3%
3/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Subcutaneous abscess
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Subdiaphragmatic abscess
|
0.00%
0/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
2/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
General physical condition abnormal
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Transaminases increased
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.8%
2/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
2/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.8%
2/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Hepatic encephalopathy
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Myasthenia gravis
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Seizure
|
0.00%
0/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal failure
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.8%
2/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
2/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.8%
2/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
2.8%
2/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.8%
2/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Andecaliximab + Nivolumab
n=71 participants at risk
Andecaliximab 800 mg administered via intravenous (IV) infusion plus nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 34 weeks at the time of the primary efficacy analysis; up to 101 weeks at the time of the safety follow-up analysis).
|
Nivolumab
n=70 participants at risk
Nivolumab 3 mg/kg administered via IV infusion every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 41 weeks at the time of the primary efficacy analysis; up to 97 weeks at the time of the safety follow-up analysis).
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
25.4%
18/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.7%
18/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
15.5%
11/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
2/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
9.9%
7/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
4/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
19.7%
14/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
14/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.6%
4/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
2/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
15.5%
11/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
22.9%
16/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
19.7%
14/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.9%
9/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
2.8%
2/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
5/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.0%
5/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
2/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
16.9%
12/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.4%
8/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
8.5%
6/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
2/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
38.0%
27/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
24.3%
17/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
31.0%
22/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.7%
18/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
29.6%
21/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
17.1%
12/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
4/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
31.0%
22/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
35.7%
25/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
8.5%
6/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.6%
6/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
14.1%
10/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
4/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
5.6%
4/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
4.2%
3/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
4/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
9.9%
7/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
5.6%
4/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
4/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
5.6%
4/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
4/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Weight decreased
|
7.0%
5/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
7/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.8%
24/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
20/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.8%
2/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
5/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.8%
2/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
4/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
4/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.0%
5/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
7/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.6%
4/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
1/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.8%
2/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
5/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
4/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.6%
6/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.5%
11/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
5/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
4/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.2%
3/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
4/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
8.5%
6/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.4%
8/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
8.5%
6/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.6%
6/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
1.4%
1/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
4/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
7.0%
5/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
2/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
4.2%
3/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.9%
9/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
4/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.4%
8/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.1%
10/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.9%
9/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.2%
3/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.6%
6/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
7.0%
5/71 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
2/70 • All-Cause Mortality: Andecaliximab + Nivolumab median follow-up time: 28.2 months; Nivolumab median follow-up time: 28.4 months; Adverse Events: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
All-Cause Mortality: The Intent-to treat Analysis Set included all participants randomized in the study. Adverse Events:The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER