Trial Outcomes & Findings for Bendamustine Hydrochloride in Combination With Rituximab in Patients With Relapsed Refractory Mantle Cell Lymphoma (NCT NCT00891839)
NCT ID: NCT00891839
Last Updated: 2014-11-04
Results Overview
The International Working Group (IWG) criteria (Cheson et al 2007) for a complete response is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A partial response 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. 95% CIs are calculated using binomial exact method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
Month 3 (end of cycle 3), Month 6 (end of cycle 6)
Results posted on
2014-11-04
Participant Flow
Forty-five patients were screened and all were enrolled.
Participant milestones
| Measure |
Bendamustine+Rituximab
Participants receive bendamustine at 90 mg/m\^2 intravenously (iv) on days 1 and 2, and 375 mg/m\^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
|
|---|---|
|
Overall Study
STARTED
|
45
|
|
Overall Study
COMPLETED
|
38
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Bendamustine+Rituximab
Participants receive bendamustine at 90 mg/m\^2 intravenously (iv) on days 1 and 2, and 375 mg/m\^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Disease progression
|
3
|
Baseline Characteristics
Bendamustine Hydrochloride in Combination With Rituximab in Patients With Relapsed Refractory Mantle Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Bendamustine+Rituximab
n=45 Participants
Participants receive bendamustine at 90 mg/m\^2 intravenously (iv) on days 1 and 2, and 375 mg/m\^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
|
|---|---|
|
Age, Continuous
|
69.5 years
STANDARD_DEVIATION 8.02 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Weight
|
80.3 kg
STANDARD_DEVIATION 13.59 • n=5 Participants
|
|
Height
|
172.7 cm
STANDARD_DEVIATION 9.87 • n=5 Participants
|
|
Body Surface Area (BSA)
|
1.9 m^2
STANDARD_DEVIATION 0.20 • n=5 Participants
|
|
Ann Arbor Staging System of Lymphoma
Stage I
|
0 participants
n=5 Participants
|
|
Ann Arbor Staging System of Lymphoma
Stage II
|
4 participants
n=5 Participants
|
|
Ann Arbor Staging System of Lymphoma
Stage III
|
4 participants
n=5 Participants
|
|
Ann Arbor Staging System of Lymphoma
Stage IV
|
37 participants
n=5 Participants
|
|
B-Symptoms
Present
|
9 participants
n=5 Participants
|
|
B-Symptoms
Absent
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 3 (end of cycle 3), Month 6 (end of cycle 6)Population: Safety population consisting of all participants treated with at least 1 dose of bendamustine HCL.
The International Working Group (IWG) criteria (Cheson et al 2007) for a complete response is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A partial response 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. 95% CIs are calculated using binomial exact method.
Outcome measures
| Measure |
Bendamustine+Rituximab
n=45 Participants
Participants receive bendamustine at 90 mg/m\^2 intravenously (iv) on days 1 and 2, and 375 mg/m\^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
|
|---|---|
|
Overall Response Rate (Complete Response + Partial Response) at the End of Cycles 3 and 6 Using the 2007 International Working Group Criteria
end of Cycle 3
|
71 percentage of participants
Interval 55.7 to 83.6
|
|
Overall Response Rate (Complete Response + Partial Response) at the End of Cycles 3 and 6 Using the 2007 International Working Group Criteria
end of Cycle 6
|
82 percentage of participants
Interval 68.0 to 92.0
|
SECONDARY outcome
Timeframe: Day 1 up to Month 43Population: Safety population of participants who had a response.
Duration of response is defined as the time between the date of the first response to date of progression or death. Response is determined on the basis of the 2007 IWG criteria. A complete response is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A partial response 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 |
Bendamustine+Rituximab
n=37 Participants
Participants receive bendamustine at 90 mg/m\^2 intravenously (iv) on days 1 and 2, and 375 mg/m\^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
|
|---|---|
|
Kaplan-Meier Estimate for Duration of Response
|
18.9 months
Interval 13.3 to 35.3
|
SECONDARY outcome
Timeframe: Day 1 up to Month 45Population: Safety population
Progression-free survival is defined as the time from first exposure to study medication to disease progression or relapse, or death due to any cause. Progression is defined using the 2007 International Working Group criteria, as any new lesion or increase by at least 50% of previously involved sites from nadir.
Outcome measures
| Measure |
Bendamustine+Rituximab
n=45 Participants
Participants receive bendamustine at 90 mg/m\^2 intravenously (iv) on days 1 and 2, and 375 mg/m\^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
|
|---|---|
|
Kaplan-Meier Estimate for Progression-Free Survival
|
17.2 months
Interval 13.2 to 24.0
|
SECONDARY outcome
Timeframe: Day 1 up to Month 57Population: Safety population
Overall survival is defined as the time from first exposure to study medication to death, or to last date from adverse events, concomitant medications, vital signs, lost to follow-up, or last known alive, for overall survival censoring date.
Outcome measures
| Measure |
Bendamustine+Rituximab
n=45 Participants
Participants receive bendamustine at 90 mg/m\^2 intravenously (iv) on days 1 and 2, and 375 mg/m\^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
|
|---|---|
|
Kaplan-Meier Estimate for Overall Survival
|
38.4 months
Interval 23.4 to
Upper range not estimable as not enough participants died
|
SECONDARY outcome
Timeframe: Baseline (Days -30 to 0), post treatment (up to Month 9, 30 days following completion of therapy)Population: Safety population of participants with PET data
Participants had a whole-body PET at baseline and at the end of cycle 6 or the end-of-treatment visit. Negative PET refers to PET results showing no abnormal lymph nodes; conversely, positive PET refers to PET results showing abnormal lymph nodes.
Outcome measures
| Measure |
Bendamustine+Rituximab
n=38 Participants
Participants receive bendamustine at 90 mg/m\^2 intravenously (iv) on days 1 and 2, and 375 mg/m\^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
|
|---|---|
|
Shifts in Baseline to Post-Treatment in Positron Emission Tomography (PET)
Baseline Positive - Study Positive
|
15 participants
|
|
Shifts in Baseline to Post-Treatment in Positron Emission Tomography (PET)
Baseline Negative - Study Negative
|
0 participants
|
|
Shifts in Baseline to Post-Treatment in Positron Emission Tomography (PET)
Baseline Positive - Study Negative
|
0 participants
|
|
Shifts in Baseline to Post-Treatment in Positron Emission Tomography (PET)
Baseline Negative - Study Positive
|
23 participants
|
SECONDARY outcome
Timeframe: Day 0 (baseline) up to Month 8Population: Safety population. One participant dropped out prior to obtaining a post-treatment ECOG evaluation.
The ECOG scale is: * Grade 0: Fully active, able to carry on all pre-disease activities without restriction; * Grade 1: Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; * Grade 2: Ambulatory and capable of all self-care but unable to work. Up and about more than 50% of waking hours; * Grade 3: Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; * Grade 4: Completely disabled. Cannot carry on any self-care. Confined to bed or Chair. The shift table compares baseline ECOG scores to the ECOG scores as of the last treatment visit.
Outcome measures
| Measure |
Bendamustine+Rituximab
n=44 Participants
Participants receive bendamustine at 90 mg/m\^2 intravenously (iv) on days 1 and 2, and 375 mg/m\^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
|
|---|---|
|
Shifts in Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status
Improved
|
8 participants
|
|
Shifts in Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status
Stayed the same
|
32 participants
|
|
Shifts in Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status
Deteriorated
|
4 participants
|
Adverse Events
Bendamustine+Rituximab
Serious events: 18 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bendamustine+Rituximab
n=45 participants at risk
Participants receive bendamustine at 90 mg/m\^2 intravenously (iv) on days 1 and 2, and 375 mg/m\^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.2%
1/45 • Number of events 1 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.2%
1/45 • Number of events 1 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Cardiac disorders
Cardiac failure congestive
|
2.2%
1/45 • Number of events 1 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Cardiac disorders
Myocardial infarction
|
2.2%
1/45 • Number of events 1 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
2.2%
1/45 • Number of events 1 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
1/45 • Number of events 1 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Gastrointestinal disorders
Haematochezia
|
2.2%
1/45 • Number of events 1 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
General disorders
Infusion related reaction
|
2.2%
1/45 • Number of events 1 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
General disorders
Pyrexia
|
2.2%
1/45 • Number of events 1 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Infections and infestations
Bronchitis
|
2.2%
1/45 • Number of events 1 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Infections and infestations
Device related infection
|
2.2%
1/45 • Number of events 1 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Infections and infestations
Pneumonia
|
6.7%
3/45 • Number of events 3 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Infections and infestations
Toxoplasmosis
|
2.2%
1/45 • Number of events 1 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.2%
1/45 • Number of events 1 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Infections and infestations
Urinary tract infection
|
2.2%
1/45 • Number of events 1 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Infections and infestations
Urosepsis
|
2.2%
1/45 • Number of events 1 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.2%
1/45 • Number of events 1 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
1/45 • Number of events 1 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
2.2%
1/45 • Number of events 1 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.2%
1/45 • Number of events 1 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Burkitt's lymphoma
|
2.2%
1/45 • Number of events 1 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
2.2%
1/45 • Number of events 1 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare
|
2.2%
1/45 • Number of events 1 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Nervous system disorders
Sedation
|
2.2%
1/45 • Number of events 1 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Psychiatric disorders
Confusional state
|
4.4%
2/45 • Number of events 2 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Psychiatric disorders
Hallucination, auditory
|
2.2%
1/45 • Number of events 1 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Psychiatric disorders
Hallucination, visual
|
2.2%
1/45 • Number of events 1 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Psychiatric disorders
Mental status changes
|
2.2%
1/45 • Number of events 1 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Renal and urinary disorders
Ureteric obstruction
|
2.2%
1/45 • Number of events 1 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
2.2%
1/45 • Number of events 1 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.2%
1/45 • Number of events 1 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.2%
1/45 • Number of events 1 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.4%
2/45 • Number of events 2 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.2%
1/45 • Number of events 1 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.2%
1/45 • Number of events 1 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.2%
1/45 • Number of events 1 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
Other adverse events
| Measure |
Bendamustine+Rituximab
n=45 participants at risk
Participants receive bendamustine at 90 mg/m\^2 intravenously (iv) on days 1 and 2, and 375 mg/m\^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
22.2%
10/45 • Number of events 14 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Blood and lymphatic system disorders
Leukopenia
|
20.0%
9/45 • Number of events 12 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
13.3%
6/45 • Number of events 9 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Blood and lymphatic system disorders
Neutropenia
|
46.7%
21/45 • Number of events 29 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
26.7%
12/45 • Number of events 21 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Cardiac disorders
Tachycardia
|
13.3%
6/45 • Number of events 6 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Eye disorders
Vision blurred
|
6.7%
3/45 • Number of events 3 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Gastrointestinal disorders
Abdominal pain
|
13.3%
6/45 • Number of events 6 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Gastrointestinal disorders
Constipation
|
37.8%
17/45 • Number of events 32 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Gastrointestinal disorders
Diarrhoea
|
35.6%
16/45 • Number of events 26 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Gastrointestinal disorders
Dry mouth
|
11.1%
5/45 • Number of events 7 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
3/45 • Number of events 4 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Gastrointestinal disorders
Flatulence
|
6.7%
3/45 • Number of events 3 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Gastrointestinal disorders
Nausea
|
68.9%
31/45 • Number of events 61 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Gastrointestinal disorders
Stomatitis
|
6.7%
3/45 • Number of events 3 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Gastrointestinal disorders
Vomiting
|
35.6%
16/45 • Number of events 27 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
General disorders
Asthenia
|
11.1%
5/45 • Number of events 7 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
General disorders
Chest pain
|
6.7%
3/45 • Number of events 6 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
General disorders
Chills
|
15.6%
7/45 • Number of events 15 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
General disorders
Fatigue
|
55.6%
25/45 • Number of events 36 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
General disorders
Infusion related reaction
|
8.9%
4/45 • Number of events 8 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
General disorders
Mucosal inflammation
|
8.9%
4/45 • Number of events 4 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
General disorders
Oedema peripheral
|
15.6%
7/45 • Number of events 12 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
General disorders
Pyrexia
|
28.9%
13/45 • Number of events 24 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Immune system disorders
Cytokine release syndrome
|
11.1%
5/45 • Number of events 11 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Infections and infestations
Pneumonia
|
6.7%
3/45 • Number of events 3 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Infections and infestations
Sinusitis
|
6.7%
3/45 • Number of events 3 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Infections and infestations
Upper respiratory tract infection
|
13.3%
6/45 • Number of events 6 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Infections and infestations
Urinary tract infection
|
8.9%
4/45 • Number of events 4 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
6.7%
3/45 • Number of events 3 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.7%
3/45 • Number of events 4 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Investigations
Neutrophil count decreased
|
6.7%
3/45 • Number of events 4 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Investigations
Weight decreased
|
31.1%
14/45 • Number of events 15 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
42.2%
19/45 • Number of events 25 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.9%
4/45 • Number of events 5 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
20.0%
9/45 • Number of events 14 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
8.9%
4/45 • Number of events 7 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.7%
3/45 • Number of events 3 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.9%
4/45 • Number of events 5 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.8%
8/45 • Number of events 10 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.9%
4/45 • Number of events 7 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.7%
3/45 • Number of events 3 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.7%
3/45 • Number of events 3 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.9%
4/45 • Number of events 6 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
3/45 • Number of events 3 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Nervous system disorders
Dizziness
|
24.4%
11/45 • Number of events 18 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Nervous system disorders
Dysgeusia
|
8.9%
4/45 • Number of events 5 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Nervous system disorders
Headache
|
17.8%
8/45 • Number of events 13 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Psychiatric disorders
Anxiety
|
6.7%
3/45 • Number of events 5 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Psychiatric disorders
Confusional state
|
6.7%
3/45 • Number of events 3 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Psychiatric disorders
Insomnia
|
20.0%
9/45 • Number of events 11 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
26.7%
12/45 • Number of events 18 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
28.9%
13/45 • Number of events 22 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
6.7%
3/45 • Number of events 4 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.1%
5/45 • Number of events 7 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.7%
3/45 • Number of events 5 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.7%
3/45 • Number of events 4 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
6.7%
3/45 • Number of events 3 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.3%
6/45 • Number of events 6 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.3%
6/45 • Number of events 14 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Vascular disorders
Flushing
|
8.9%
4/45 • Number of events 5 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Vascular disorders
Hypertension
|
6.7%
3/45 • Number of events 4 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
|
Vascular disorders
Hypotension
|
20.0%
9/45 • Number of events 12 • Day 1 up to Month 8
Participants are counted only once in each preferred term category, and only once in each system organ class category and high-level term.
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products, R&D Inc.
Phone: 215-591-3000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
- Publication restrictions are in place
Restriction type: OTHER