Trial Outcomes & Findings for A Study of TRU-016 in Combination With Rituximab and Bendamustine in Subjects With Relapsed Indolent Lymphoma (NCT NCT01317901)
NCT ID: NCT01317901
Last Updated: 2017-06-28
Results Overview
Response was assessed by the investigator on the basis of clinical, radiological, and pathological (i.e., bone marrow) criteria, using the IWG criteria (Cheson et al 2007). A CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Day 15 and Day 28 of even-numbered cycles
Results posted on
2017-06-28
Participant Flow
Twelve adult patients, 6 in each dose group, were enrolled at 4 hospitals between May and October 2011.
Participant milestones
| Measure |
10 mg/kg TRU-016+Bendamustine+Rituximab
TRU-016: 100 mg TRU-016 lyophilized solution for infusion at 10 mg/kg (or 6 mg/kg, if necessary) on Days 1 and 15 of each 28 day cycle Rituximab: 375 mg/m\^2 rituximab was administered by IV infusion on Day 2 of each cycle.
Bendamustine: 90 mg/m\^2 bendamustine was administered by IV infusion on Days 1 and 2 of each cycle.
|
20 mg/kg TRU-016+Bendamustine+Rituximab
TRU-016: 100 mg TRU-016 lyophilized solution for infusion at 10 mg/kg (or 6 mg/kg, if necessary) on Days 1 and 15 of each 28 day cycle Rituximab: 375 mg/m\^2 rituximab was administered by IV infusion on Day 2 of each cycle.
Bendamustine: 90 mg/m\^2 bendamustine was administered by IV infusion on Days 1 and 2 of each cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of TRU-016 in Combination With Rituximab and Bendamustine in Subjects With Relapsed Indolent Lymphoma
Baseline characteristics by cohort
| Measure |
TRU-016 (10 mg/kg) +Bendamustine+Rituximab
n=6 Participants
|
TRU-016 (20 mg/kg) +Bendamustine+Rituximab
n=6 Participants
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.3 years
STANDARD_DEVIATION 4.76 • n=5 Participants
|
64.3 years
STANDARD_DEVIATION 10.61 • n=7 Participants
|
60.8 years
STANDARD_DEVIATION 8.65 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
β2-microglobulin
|
2.4 MG/l
STANDARD_DEVIATION 1.3 • n=5 Participants
|
2.9 MG/l
STANDARD_DEVIATION 1.9 • n=7 Participants
|
2.6 MG/l
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
Sum of product diameters
|
40.9 cm2
STANDARD_DEVIATION 26.5 • n=5 Participants
|
35.0 cm2
STANDARD_DEVIATION 32.6 • n=7 Participants
|
37.9 cm2
STANDARD_DEVIATION 28.5 • n=5 Participants
|
|
Time since first diagnosis of primary cancer
|
3.2 years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
6.0 years
STANDARD_DEVIATION 4.7 • n=7 Participants
|
4.6 years
STANDARD_DEVIATION 4.0 • n=5 Participants
|
|
Direct Anti-globulin Test
Positive
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Direct Anti-globulin Test
Negative
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Direct Anti-globulin Test
unknown
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Staging at diagnosis
Stage 1
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Staging at diagnosis
Stage 2
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Staging at diagnosis
Stage 3
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Staging at diagnosis
Stage 4
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Staging at diagnosis
Not done
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
FLIPI
Low risk (0-1 points)
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
FLIPI
Intermediate risk (2 points)
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
FLIPI
Highrisk (3-5 points)
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 15 and Day 28 of even-numbered cyclesPopulation: All treated subjects
Response was assessed by the investigator on the basis of clinical, radiological, and pathological (i.e., bone marrow) criteria, using the IWG criteria (Cheson et al 2007). A CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.
Outcome measures
| Measure |
TRU-016 (10 mg/kg) + Bendamustine + Rituximab
n=6 Participants
10 mg/kg of TRU 016 combined with rituximab 375 mg/m\^2 and bendamustine 90 mg/m\^2 were evaluated during up to 6 cycles (28 days each). TRU-016 was administered by intravenous (IV) infusion on Days 1 and 15 of each cycle. Rituximab was administered by IV infusion on Day 2 of each cycle. Bendamustine was administered by IV infusion on Days 1 and 2 of each cycle. Subjects received study treatment for up to 6 cycles.
TRU-016: 100 mg TRU-016 lyophilized solution for infusion at 10 or 20 mg/kg (or 6 mg/kg, if necessary) on Days 1 and 15 of each 28 day cycle
Bendamustine: Bendamustine by IV administration on Days 1 and 2 of each 28 day cycle.
Rituximab: Rituximab by IV administration at 375 mg/m\^2 on Day 2 of each 28 day cycle.
|
20 mg/kg of TRU 016 + Bendamustine + Rituximab
n=6 Participants
20 mg/kg of TRU 016 combined with rituximab 375 mg/m\^2 and bendamustine 90 mg/m\^2 were evaluated during up to 6 cycles (28 days each). TRU-016 was administered by intravenous (IV) infusion on Days 1 and 15 of each cycle. Rituximab was administered by IV infusion on Day 2 of each cycle. Bendamustine was administered by IV infusion on Days 1 and 2 of each cycle. Subjects received study treatment for up to 6 cycles.
|
|---|---|---|
|
Response
Complete Response
|
3 participants
|
2 participants
|
|
Response
Partial Response
|
1 participants
|
4 participants
|
|
Response
Stable disease
|
1 participants
|
0 participants
|
|
Response
Relapsed/progressive disease
|
1 participants
|
0 participants
|
Adverse Events
TRU-016 (10 mg/kg)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
TRU-016 (20 mg/kg)
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TRU-016 (10 mg/kg)
n=6 participants at risk
TRU-016 (10 mg/kg) + bendamustine + rituximab
|
TRU-016 (20 mg/kg)
n=6 participants at risk
TRU-016 (20 mg/kg) + bendamustine + rituximab
|
|---|---|---|
|
Blood and lymphatic system disorders
febrile neutropenia
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Infections and infestations
pneumonia
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Ear and labyrinth disorders
vestibular disorder
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Eye disorders
retinal vein occlusion
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
myelodysplastic syndrome
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary thrombosis
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Vascular disorders
deep vein thrombosis
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
Other adverse events
| Measure |
TRU-016 (10 mg/kg)
n=6 participants at risk
TRU-016 (10 mg/kg) + bendamustine + rituximab
|
TRU-016 (20 mg/kg)
n=6 participants at risk
TRU-016 (20 mg/kg) + bendamustine + rituximab
|
|---|---|---|
|
Blood and lymphatic system disorders
neutropenia
|
83.3%
5/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
33.3%
2/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Blood and lymphatic system disorders
anemia
|
33.3%
2/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
50.0%
3/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
50.0%
3/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Blood and lymphatic system disorders
lymphopenia
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Blood and lymphatic system disorders
febrile neutropenia
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Ear and labyrinth disorders
vestibular disorder
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Eye disorders
retinal vein occlusion
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Gastrointestinal disorders
nausea
|
50.0%
3/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
66.7%
4/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Gastrointestinal disorders
abdominal pain
|
50.0%
3/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
50.0%
3/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Gastrointestinal disorders
diarrhea
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
33.3%
2/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Gastrointestinal disorders
vomiting
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
33.3%
2/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
33.3%
2/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Gastrointestinal disorders
dry mouth
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Gastrointestinal disorders
dyspepsia
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Gastrointestinal disorders
hemorrhoids
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
General disorders
fatigue
|
50.0%
3/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
66.7%
4/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
General disorders
chill
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
33.3%
2/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
General disorders
influenza ike illness
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Cardiac disorders
Non-cardiac chest pain
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Investigations
White blood cell count decreased
|
50.0%
3/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Investigations
Neutrophil count decreased
|
50.0%
3/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
2/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Investigations
Lymphocyte count decreased
|
33.3%
2/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Investigations
Aspartate aminotransferase
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Investigations
Immunoglobulins decreased
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
50.0%
3/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Investigations
Hyponatraemia
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
33.3%
2/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Nervous system disorders
Migraine
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Nervous system disorders
Paraesthesia
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Psychiatric disorders
Insomnia
|
33.3%
2/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
33.3%
2/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
50.0%
3/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
33.3%
2/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Vascular disorders
Flushing
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
|
Skin and subcutaneous tissue disorders
Phlebitis
|
0.00%
0/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
16.7%
1/6 • 1 year
After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place