Trial Outcomes & Findings for A Study of Brentuximab Vedotin Combined With Nivolumab for Relapsed or Refractory Hodgkin Lymphoma (NCT NCT02572167)
NCT ID: NCT02572167
Last Updated: 2022-11-08
Results Overview
Treatment-emergent adverse events (TEAEs) are presented and defined as newly occurring (not present at baseline) or worsening after first dose of investigational product. The timeframe includes a 6.01 month safety reporting period and additional long-term follow up through 28.9 months.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
93 participants
Primary outcome timeframe
Up to 28.9 months
Results posted on
2022-11-08
Participant Flow
Participant milestones
| Measure |
Part 1: Staggered Dose
Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
|
Part 2: Staggered Dose Expansion
Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
|
Part 3: Same-day Dose
Brentuximab vedotin plus nivolumab brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
56
|
31
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
56
|
31
|
Reasons for withdrawal
| Measure |
Part 1: Staggered Dose
Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
|
Part 2: Staggered Dose Expansion
Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
|
Part 3: Same-day Dose
Brentuximab vedotin plus nivolumab brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
5
|
3
|
|
Overall Study
Death
|
0
|
8
|
3
|
|
Overall Study
Did not meet inclusion criteria
|
0
|
0
|
1
|
|
Overall Study
Study closure by Sponsor
|
4
|
40
|
24
|
Baseline Characteristics
A Study of Brentuximab Vedotin Combined With Nivolumab for Relapsed or Refractory Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Part 1: Staggered Dose
n=6 Participants
Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
|
Part 2: Staggered Dose Expansion
n=55 Participants
Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
|
Part 3: Same-day Dose
n=30 Participants
Brentuximab vedotin plus nivolumab brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
26.0 years
n=99 Participants
|
37.0 years
n=107 Participants
|
31.5 years
n=206 Participants
|
34.0 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
51 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
40 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
74 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
77 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 0
|
4 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
58 Participants
n=7 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 1
|
2 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
32 Participants
n=7 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Unknown
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Up to 28.9 monthsPopulation: The safety analysis set includes all patients who receive any amount of brentuximab vedotin or nivolumab.
Treatment-emergent adverse events (TEAEs) are presented and defined as newly occurring (not present at baseline) or worsening after first dose of investigational product. The timeframe includes a 6.01 month safety reporting period and additional long-term follow up through 28.9 months.
Outcome measures
| Measure |
Part 1: Staggered Dose
n=6 Participants
Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
|
Part 2: Staggered Dose Expansion
n=55 Participants
Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
|
Part 3: Same-day Dose
n=30 Participants
Brentuximab vedotin plus nivolumab brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Any treatment-emergent adverse event (TEAE)
|
6 Participants
|
55 Participants
|
30 Participants
|
|
Number of Participants With Adverse Events (AEs)
AEs related to brentuximab vedotin only
|
5 Participants
|
41 Participants
|
15 Participants
|
|
Number of Participants With Adverse Events (AEs)
AEs related to nivolumab only
|
3 Participants
|
20 Participants
|
13 Participants
|
|
Number of Participants With Adverse Events (AEs)
AEs related to both study drugs
|
5 Participants
|
37 Participants
|
27 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any serious adverse event (SAE)
|
0 Participants
|
16 Participants
|
5 Participants
|
|
Number of Participants With Adverse Events (AEs)
SAEs related to brentuximab vedotin only
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
SAE related to nivolumab only
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
SAE related to both study drugs
|
0 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events (AEs)
AEs leading to treatment discontinuation
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 3.42 monthsPopulation: The Efficacy Evaluable analysis set includes all patients who had an adequate baseline disease assessment, received any amount of either drug, and subsequently had an adequate response assessment.
Number of patients with complete metabolic response (CMR) at end of treatment
Outcome measures
| Measure |
Part 1: Staggered Dose
n=6 Participants
Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
|
Part 2: Staggered Dose Expansion
n=54 Participants
Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
|
Part 3: Same-day Dose
n=30 Participants
Brentuximab vedotin plus nivolumab brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
|
|---|---|---|---|
|
Complete Remission Rate
|
4 Participants
|
33 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Up to 3.42 monthsPopulation: The Efficacy Evaluable analysis set includes all patients who had an adequate baseline disease assessment, received any amount of either drug, and subsequently had an adequate response assessment.
Number of patients with complete metabolic response (CMR) or partial metabolic response (PMR)
Outcome measures
| Measure |
Part 1: Staggered Dose
n=6 Participants
Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
|
Part 2: Staggered Dose Expansion
n=54 Participants
Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
|
Part 3: Same-day Dose
n=30 Participants
Brentuximab vedotin plus nivolumab brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
|
|---|---|---|---|
|
Objective Response Rate
|
6 Participants
|
43 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Up to 69.3 monthsPopulation: The Efficacy Evaluable analysis set includes all patients who had an adequate baseline disease assessment, received any amount of either drug, and subsequently had an adequate response assessment.
The time from start of the first documentation of complete response (CR) to the first documentation of tumor progression (PD) including radiographic evidence of progression and clinical progression per investigator or to death due to any cause, whichever comes first.
Outcome measures
| Measure |
Part 1: Staggered Dose
n=4 Participants
Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
|
Part 2: Staggered Dose Expansion
n=33 Participants
Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
|
Part 3: Same-day Dose
n=24 Participants
Brentuximab vedotin plus nivolumab brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
|
|---|---|---|---|
|
Duration of Complete Response
|
NA Months
Interval 0.0 to 69.3
The median duration of CR was not reached for any part of this study.
|
NA Months
Interval 0.0 to 61.9
The median duration of CR was not reached for any part of this study.
|
NA Months
Interval 0.0 to 50.4
The median duration of CR was not reached for any part of this study.
|
SECONDARY outcome
Timeframe: Up to 69.3 monthsPopulation: The Efficacy Evaluable analysis set includes all patients who had an adequate baseline disease assessment, received any amount of either drug, and subsequently had an adequate response assessment.
The time from start of the first documentation of OR (CR or PR) to the first documentation of PD or to death due to any cause, whichever comes first.
Outcome measures
| Measure |
Part 1: Staggered Dose
n=6 Participants
Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
|
Part 2: Staggered Dose Expansion
n=43 Participants
Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
|
Part 3: Same-day Dose
n=28 Participants
Brentuximab vedotin plus nivolumab brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
|
|---|---|---|---|
|
Duration of Objective Response
|
NA Months
Interval 0.0 to 69.3
The median duration of OR was not reached for any part of this study.
|
NA Months
Interval 0.0 to 61.9
The median duration of OR was not reached for any part of this study.
|
NA Months
Interval 0.0 to 50.4
The median duration of OR was not reached for any part of this study.
|
SECONDARY outcome
Timeframe: Up to 67.3 monthsPopulation: Subset includes all patients who received any amount of brentuximab vedotin or nivolumab and who received a stem cell transplant without intervening salvage after study treatment.
For participants who undergo ASCT, the time from ASCT to the first documentation of PD or to death due to any cause, whichever comes first.
Outcome measures
| Measure |
Part 1: Staggered Dose
n=6 Participants
Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
|
Part 2: Staggered Dose Expansion
n=36 Participants
Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
|
Part 3: Same-day Dose
n=25 Participants
Brentuximab vedotin plus nivolumab brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
|
|---|---|---|---|
|
Progression-free Survival Post-autologous Stem Cell Transplant
|
NA Months
Interval 0.0 to 67.3
The median duration of PFS was not reached for any part of this study.
|
NA Months
Interval 0.0 to 61.1
The median duration of PFS was not reached for any part of this study.
|
NA Months
Interval 0.0 to 48.8
The median duration of PFS was not reached for any part of this study.
|
Adverse Events
Part 1: Staggered Dose
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 2: Staggered Dose Expansion
Serious events: 16 serious events
Other events: 55 other events
Deaths: 8 deaths
Part 3: Same-day Dose
Serious events: 5 serious events
Other events: 30 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Part 1: Staggered Dose
n=6 participants at risk
Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
|
Part 2: Staggered Dose Expansion
n=55 participants at risk
Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
|
Part 3: Same-day Dose
n=30 participants at risk
Brentuximab vedotin plus nivolumab brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
7.3%
4/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
6.7%
2/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
1.8%
1/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.3%
1/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
1.8%
1/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
1.8%
1/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
5.5%
3/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.3%
1/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
1.8%
1/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.3%
1/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.3%
1/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
1.8%
1/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Infections and infestations
Necrotising soft tissue infection
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.3%
1/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Infections and infestations
Septic shock
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.3%
1/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Infections and infestations
Systemic candida
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
1.8%
1/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
1.8%
1/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.3%
1/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.6%
2/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
1.8%
1/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
1.8%
1/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
1.8%
1/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.3%
1/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
5.5%
3/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.3%
1/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
General disorders
Malaise
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
1.8%
1/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
General disorders
Pain
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
1.8%
1/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
1.8%
1/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
1.8%
1/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
1.8%
1/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
1.8%
1/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
1.8%
1/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
1.8%
1/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
1.8%
1/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
1.8%
1/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.6%
2/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Eye disorders
Uveitis
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
1.8%
1/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
1.8%
1/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Nervous system disorders
Guillain-barre syndrome
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.3%
1/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
1.8%
1/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
Other adverse events
| Measure |
Part 1: Staggered Dose
n=6 participants at risk
Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
|
Part 2: Staggered Dose Expansion
n=55 participants at risk
Brentuximab vedotin plus nivolumab; staggered dose in Cycle 1 only. brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
|
Part 3: Same-day Dose
n=30 participants at risk
Brentuximab vedotin plus nivolumab brentuximab vedotin: 1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles nivolumab: 3 mg/kg by intravenous (IV) infusion for up to 4 cycles
|
|---|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
16.4%
9/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.3%
1/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
83.3%
5/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
54.5%
30/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
50.0%
15/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
33.3%
2/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
23.6%
13/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
36.7%
11/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
25.5%
14/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
33.3%
10/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
21.8%
12/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
20.0%
6/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
50.0%
3/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
20.0%
11/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
16.7%
5/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
16.4%
9/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
23.3%
7/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
16.4%
9/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
6.7%
2/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
10.9%
6/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
13.3%
4/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
9.1%
5/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
10.0%
3/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
9.1%
5/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.3%
1/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.6%
2/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
10.0%
3/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.6%
2/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Skin and subcutaneous tissue disorders
Rash follicular
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
5.5%
3/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.3%
1/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Skin and subcutaneous tissue disorders
Blister
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
1.8%
1/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Skin and subcutaneous tissue disorders
Rash morbilliform
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
6.7%
2/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
General disorders
Fatigue
|
100.0%
6/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
70.9%
39/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
93.3%
28/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
General disorders
Pyrexia
|
33.3%
2/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
43.6%
24/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
53.3%
16/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
General disorders
Chills
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
29.1%
16/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
36.7%
11/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
General disorders
Chest discomfort
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
16.4%
9/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
16.7%
5/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
General disorders
Pain
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
9.1%
5/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
30.0%
9/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
General disorders
Non-cardiac chest pain
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
7.3%
4/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
16.7%
5/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
General disorders
Oedema peripheral
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
12.7%
7/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.3%
1/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
General disorders
Asthenia
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
10.9%
6/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.3%
1/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
General disorders
Puncture site pain
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.6%
2/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
10.0%
3/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
General disorders
Malaise
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.6%
2/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
6.7%
2/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
General disorders
Catheter site pain
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
5.5%
3/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
General disorders
Face oedema
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
1.8%
1/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
6.7%
2/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
General disorders
Catheter site rash
|
33.3%
2/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
6/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
74.5%
41/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
93.3%
28/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Gastrointestinal disorders
Diarrhoea
|
83.3%
5/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
58.2%
32/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
73.3%
22/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
6/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
45.5%
25/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
60.0%
18/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
3/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
40.0%
22/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
43.3%
13/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Gastrointestinal disorders
Stomatitis
|
66.7%
4/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
34.5%
19/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
40.0%
12/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
25.5%
14/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
33.3%
10/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
21.8%
12/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
10.0%
3/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
18.2%
10/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.3%
1/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
9.1%
5/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
13.3%
4/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Gastrointestinal disorders
Abdominal distension
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
7.3%
4/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.3%
1/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
5.5%
3/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.3%
1/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
9.1%
5/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.6%
2/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
6.7%
2/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
5.5%
3/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Gastrointestinal disorders
Proctalgia
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
1.8%
1/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.3%
1/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
6.7%
2/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
100.0%
6/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
52.7%
29/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
66.7%
20/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Blood and lymphatic system disorders
Anaemia
|
100.0%
6/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
43.6%
24/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
53.3%
16/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Blood and lymphatic system disorders
Neutropenia
|
100.0%
6/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
34.5%
19/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
40.0%
12/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
83.3%
5/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
21.8%
12/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
20.0%
6/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
12.7%
7/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
23.3%
7/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
7.3%
4/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
6.7%
2/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
10.0%
3/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
36.4%
20/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
33.3%
10/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
2/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
27.3%
15/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
26.7%
8/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
23.6%
13/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.3%
1/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
33.3%
2/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
7.3%
4/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
16.7%
5/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
7.3%
4/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
13.3%
4/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
12.7%
7/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.3%
1/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
9.1%
5/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
10.0%
3/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
9.1%
5/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.3%
1/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.6%
2/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
10.0%
3/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
13.3%
4/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.6%
2/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
6.7%
2/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.6%
2/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.3%
1/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
5.5%
3/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Nervous system disorders
Headache
|
50.0%
3/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
38.2%
21/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
43.3%
13/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
2/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
34.5%
19/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
33.3%
10/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
23.6%
13/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
13.3%
4/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Nervous system disorders
Paraesthesia
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
12.7%
7/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
10.0%
3/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
7.3%
4/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
7.3%
4/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
6.7%
2/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Nervous system disorders
Syncope
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
7.3%
4/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.3%
1/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
7.3%
4/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
5.5%
3/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
6.7%
2/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
2/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
27.3%
15/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
23.3%
7/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
50.0%
3/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
16.4%
9/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
23.3%
7/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
50.0%
3/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
20.0%
11/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
13.3%
4/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
66.7%
4/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
12.7%
7/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
20.0%
6/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
10.9%
6/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.3%
1/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
10.9%
6/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.3%
1/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.6%
2/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.3%
1/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
2/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
27.3%
15/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
43.3%
13/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
18.2%
10/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
33.3%
10/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
14.5%
8/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
10.0%
3/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
9.1%
5/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
6.7%
2/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.6%
2/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
16.7%
5/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
7.3%
4/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
6.7%
2/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
7.3%
4/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.3%
1/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
1.8%
1/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
10.0%
3/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
5.5%
3/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.3%
1/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Metabolism and nutrition disorders
Hyperlipasaemia
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
1.8%
1/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
6.7%
2/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
1.8%
1/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
6.7%
2/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
6.7%
2/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
45.5%
25/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
46.7%
14/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
25.5%
14/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
33.3%
10/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
12.7%
7/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
13.3%
4/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
6.7%
2/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
50.0%
3/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
45.5%
25/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
36.7%
11/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.6%
2/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
6.7%
2/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Vascular disorders
Hypotension
|
33.3%
2/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
20.0%
11/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
30.0%
9/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Vascular disorders
Flushing
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
18.2%
10/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
10.0%
3/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
20.0%
11/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
10.0%
3/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Vascular disorders
Hot flush
|
33.3%
2/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
9.1%
5/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
13.3%
4/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
9.1%
5/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Vascular disorders
Deep vein thrombosis
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
1.8%
1/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Vascular disorders
Superior vena cava syndrome
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
12.7%
7/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
16.7%
5/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.6%
2/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
10.0%
3/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Infections and infestations
Folliculitis
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.6%
2/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Infections and infestations
Fungal skin infection
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
1.8%
1/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.3%
1/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
6.7%
2/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Infections and infestations
Rash pustular
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.3%
1/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
6.7%
2/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Infections and infestations
Herpes simplex
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Infections and infestations
Pneumonia
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Infections and infestations
Rhinovirus infection
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Investigations
Transaminases increased
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
7.3%
4/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
6.7%
2/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
7.3%
4/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
6.7%
2/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Investigations
Weight decreased
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
7.3%
4/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
6.7%
2/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.6%
2/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
6.7%
2/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Investigations
Weight increased
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
5.5%
3/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.3%
1/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
10.0%
3/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
1.8%
1/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
6.7%
2/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
6.7%
2/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Cardiac disorders
Tachycardia
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
16.4%
9/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
13.3%
4/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
5.5%
3/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
6.7%
2/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
5.5%
3/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
6.7%
2/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
9.1%
5/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
10.0%
3/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
5.5%
3/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
6.7%
2/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
1.8%
1/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
6.7%
2/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
5.5%
3/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
1.8%
1/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Renal and urinary disorders
Urinary tract pain
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
9.1%
5/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
6.7%
2/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Immune system disorders
Engraftment syndrome
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
5.5%
3/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
6.7%
2/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
7.3%
4/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
10.0%
3/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
6.7%
2/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Endocrine disorders
Thyroiditis
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.3%
1/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Eye disorders
Dry eye
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
7.3%
4/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.3%
1/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Eye disorders
Vision blurred
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
1.8%
1/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
6.7%
2/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
1.8%
1/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.3%
1/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
16.7%
1/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.6%
2/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
13.3%
4/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Product Issues
Thrombosis in device
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
6.7%
2/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
General disorders
Swelling face
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
5.5%
3/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
0.00%
0/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
6.7%
2/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/6 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
10.9%
6/55 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
3.3%
1/30 • Non-serious adverse events were followed up to 6.01 months. Serious adverse events and all-cause mortality were followed up to 72 months.
All-Cause Mortality includes all patients enrolled in the study. Serious Adverse Events and Other Adverse Events includes the safety analysis set - all patients who received any amount of brentuximab vedotin or nivolumab.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place