Trial Outcomes & Findings for A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy (NCT NCT01232556)
NCT ID: NCT01232556
Last Updated: 2019-01-08
Results Overview
Overall Survival (OS) was defined as the time from randomization to death due to any cause, censoring at the date of last contact or the end of the study. The Kaplan-Meier method was used to determine OS. The hazard ratio and corresponding 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
338 participants
Primary outcome timeframe
From randomization up to 5 years after last dose or up to final study visit, whichever occurs first.
Results posted on
2019-01-08
Participant Flow
Participant milestones
| Measure |
Inotuzumab Ozogamicin Plus (+) Rituximab
Participants received rituximab 375 milligrams per square meter (mg/m\^2) via intravenous (IV) infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m\^2 via IV infusion on Day 2 of each 28-day cycle for a maximum of 6 cycles.
|
Rituximab+Gemcitabine or Rituximab+Bendamustine
Participants received either R-bendamustine (rituximab 375 mg/m\^2 via IV infusion on Day 1 and bendamustine 120 mg/m\^2 via IV infusion on Days 1 and 2 in 28-day cycles for a maximum of 6 cycles) or R-gemcitabine (rituximab 375 mg/m\^2 via IV infusion on Days 1, 8, 15 and 22 of Cycle 1 and on Day 1 for all other cycles, and gemcitabine 1000 mg/m\^2 via IV infusion on Days 1, 8 and 15 of each 28-day cycle for a maximum of 6 cycles). Choice of therapy was at the discretion of the investigator.
|
|---|---|---|
|
Overall Study
STARTED
|
166
|
172
|
|
Overall Study
Treated
|
165
|
167
|
|
Overall Study
COMPLETED
|
7
|
1
|
|
Overall Study
NOT COMPLETED
|
159
|
171
|
Reasons for withdrawal
| Measure |
Inotuzumab Ozogamicin Plus (+) Rituximab
Participants received rituximab 375 milligrams per square meter (mg/m\^2) via intravenous (IV) infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m\^2 via IV infusion on Day 2 of each 28-day cycle for a maximum of 6 cycles.
|
Rituximab+Gemcitabine or Rituximab+Bendamustine
Participants received either R-bendamustine (rituximab 375 mg/m\^2 via IV infusion on Day 1 and bendamustine 120 mg/m\^2 via IV infusion on Days 1 and 2 in 28-day cycles for a maximum of 6 cycles) or R-gemcitabine (rituximab 375 mg/m\^2 via IV infusion on Days 1, 8, 15 and 22 of Cycle 1 and on Day 1 for all other cycles, and gemcitabine 1000 mg/m\^2 via IV infusion on Days 1, 8 and 15 of each 28-day cycle for a maximum of 6 cycles). Choice of therapy was at the discretion of the investigator.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
21
|
17
|
|
Overall Study
Death
|
97
|
97
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Terminated by Sponsor
|
35
|
51
|
|
Overall Study
Other
|
6
|
4
|
Baseline Characteristics
A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy
Baseline characteristics by cohort
| Measure |
Inotuzumab Ozogamicin+Rituximab
n=166 Participants
Participants received rituximab 375 mg/m\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m\^2 via IV infusion on Day 2 of each 28-day cycle for a maximum of 6 cycles.
|
Rituximab+Gemcitabine or Rituximab+Bendamustine
n=172 Participants
Participants received either R-bendamustine (rituximab 375 mg/m\^2 via IV infusion on Day 1 and bendamustine 120 mg/m\^2 via IV infusion on Days 1 and 2 in 28-day cycles for a maximum of 6 cycles) or R-gemcitabine (rituximab 375 mg/m\^2 via IV infusion on Days 1, 8, 15 and 22 of Cycle 1 and on Day 1 for all other cycles, and gemcitabine 1000 mg/m\^2 via IV infusion on Days 1, 8 and 15 of each 28-day cycle for a maximum of 6 cycles). Choice of therapy was at the discretion of the investigator.
|
Total
n=338 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.6 Years
STANDARD_DEVIATION 12.29 • n=5 Participants
|
66.9 Years
STANDARD_DEVIATION 11.40 • n=7 Participants
|
67.7 Years
STANDARD_DEVIATION 11.86 • n=5 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
91 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization up to 5 years after last dose or up to final study visit, whichever occurs first.Population: ITT Population.
Overall Survival (OS) was defined as the time from randomization to death due to any cause, censoring at the date of last contact or the end of the study. The Kaplan-Meier method was used to determine OS. The hazard ratio and corresponding 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.
Outcome measures
| Measure |
Inotuzumab Ozogamicin+Rituximab
n=166 Participants
Participants received rituximab 375 mg/m\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m\^2 via IV infusion on Day 2 of each 28-day cycle for a maximum of 6 cycles.
|
Rituximab+Gemcitabine or Rituximab+Bendamustine
n=172 Participants
Participants received either R-bendamustine (rituximab 375 mg/m\^2 via IV infusion on Day 1 and bendamustine 120 mg/m\^2 via IV infusion on Days 1 and 2 in 28-day cycles for a maximum of 6 cycles) or R-gemcitabine (rituximab 375 mg/m\^2 via IV infusion on Days 1, 8, 15 and 22 of Cycle 1 and on Day 1 for all other cycles, and gemcitabine 1000 mg/m\^2 via IV infusion on Days 1, 8 and 15 of each 28-day cycle for a maximum of 6 cycles). Choice of therapy was at the discretion of the investigator.
|
|---|---|---|
|
Overall Survival
|
9.5 Months
Interval 7.0 to 14.5
|
9.5 Months
Interval 7.7 to 14.1
|
PRIMARY outcome
Timeframe: Up to 20 weeks after the first dose of study drugPopulation: Safety Population - included all participants who received at least 1 dose of test article (either inotuzumab ozogamicin administrated in combination with rituximab or investigator's choice). This population only excluded participants who never received any test article.
Includes all TEAEs: Any event that occurred after the first dose of study drug and was not present prior to study drug administration or worsened in severity after study drug administration..
Outcome measures
| Measure |
Inotuzumab Ozogamicin+Rituximab
n=164 Participants
Participants received rituximab 375 mg/m\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m\^2 via IV infusion on Day 2 of each 28-day cycle for a maximum of 6 cycles.
|
Rituximab+Gemcitabine or Rituximab+Bendamustine
n=167 Participants
Participants received either R-bendamustine (rituximab 375 mg/m\^2 via IV infusion on Day 1 and bendamustine 120 mg/m\^2 via IV infusion on Days 1 and 2 in 28-day cycles for a maximum of 6 cycles) or R-gemcitabine (rituximab 375 mg/m\^2 via IV infusion on Days 1, 8, 15 and 22 of Cycle 1 and on Day 1 for all other cycles, and gemcitabine 1000 mg/m\^2 via IV infusion on Days 1, 8 and 15 of each 28-day cycle for a maximum of 6 cycles). Choice of therapy was at the discretion of the investigator.
|
|---|---|---|
|
Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population)
% participants with a TEAE
|
98.8 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population)
% participants with Grade 3 or 4 TEAE
|
79.9 Percentage of Participants
|
79.6 Percentage of Participants
|
|
Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population)
% participants for study drug discontinuation
|
25.0 Percentage of Participants
|
18.0 Percentage of Participants
|
|
Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population)
% participants with serious TEAE
|
37.2 Percentage of Participants
|
37.7 Percentage of Participants
|
|
Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population)
% participants with Grade 5 TEAE
|
14.6 Percentage of Participants
|
13.8 Percentage of Participants
|
|
Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population)
% participants with dose reductions due to TEAEs
|
27.4 Percentage of Participants
|
29.3 Percentage of Participants
|
|
Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population)
% participants for study drug stopped temporarily
|
31.1 Percentage of Participants
|
46.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: From randomization up to 2 years or final study visit, whichever occurs first, including but not limited to planned assessments scheduled approximately every 12 weeks.Population: ITT Population
PFS is defined as time from date of randomization to date of progressive disease (PD, including investigator's claim of clinical progression), date of death from any cause, or initiation of a new treatment for the lymphoma due to persistent/refractory disease. The Kaplan-Meier method was used to determine PFS. The hazard ratio and corresponding 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression. PD requires the following: 1. Appearance of any new lesion more than 1.5 cm in any axis during or at the end of treatment, even if other lesions are decreasing in size. 2. At least a 50% increase from nadir in the sum of the product diameters of any previously involved nodes, or in a single involved node, or the size of other lesions. 3. At least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis.
Outcome measures
| Measure |
Inotuzumab Ozogamicin+Rituximab
n=166 Participants
Participants received rituximab 375 mg/m\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m\^2 via IV infusion on Day 2 of each 28-day cycle for a maximum of 6 cycles.
|
Rituximab+Gemcitabine or Rituximab+Bendamustine
n=172 Participants
Participants received either R-bendamustine (rituximab 375 mg/m\^2 via IV infusion on Day 1 and bendamustine 120 mg/m\^2 via IV infusion on Days 1 and 2 in 28-day cycles for a maximum of 6 cycles) or R-gemcitabine (rituximab 375 mg/m\^2 via IV infusion on Days 1, 8, 15 and 22 of Cycle 1 and on Day 1 for all other cycles, and gemcitabine 1000 mg/m\^2 via IV infusion on Days 1, 8 and 15 of each 28-day cycle for a maximum of 6 cycles). Choice of therapy was at the discretion of the investigator.
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
3.7 Months
Interval 2.9 to 5.0
|
3.5 Months
Interval 2.8 to 4.9
|
SECONDARY outcome
Timeframe: Up to 2 years from first study drug dose or up to final study visit, whichever occurs first, including but not limited to planned assessments scheduled approximately every 12 weeks.Population: ITT Population
CR is defined as disappearance of all detectable clinical evidence of disease (including cleared infiltrate on repeat bone marrow aspirate/biopsy if lymphoma involvement of bone marrow before treatment). Partial Response (PR) requires the following: 1. ≥50 % decrease in SPD of the six largest dominant nodes or nodal masses. 2. No increase in the size of other nodes, liver, or spleen. 3. Splenic and hepatic nodules must regress by ≥50% in the SPD, or for single nodules, in the greatest transverse diameter. 4. With the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. 5. No new sites of disease. The 95% CI was determined using the exact method based on binomial distribution.
Outcome measures
| Measure |
Inotuzumab Ozogamicin+Rituximab
n=166 Participants
Participants received rituximab 375 mg/m\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m\^2 via IV infusion on Day 2 of each 28-day cycle for a maximum of 6 cycles.
|
Rituximab+Gemcitabine or Rituximab+Bendamustine
n=172 Participants
Participants received either R-bendamustine (rituximab 375 mg/m\^2 via IV infusion on Day 1 and bendamustine 120 mg/m\^2 via IV infusion on Days 1 and 2 in 28-day cycles for a maximum of 6 cycles) or R-gemcitabine (rituximab 375 mg/m\^2 via IV infusion on Days 1, 8, 15 and 22 of Cycle 1 and on Day 1 for all other cycles, and gemcitabine 1000 mg/m\^2 via IV infusion on Days 1, 8 and 15 of each 28-day cycle for a maximum of 6 cycles). Choice of therapy was at the discretion of the investigator.
|
|---|---|---|
|
Percentage of Participants With A Best Overall Response of CR or Partial Response (PR) Per NCI International Response Criteria for NHL
|
29.5 Percentage of Participants
Interval 22.7 to 37.08
|
29.7 Percentage of Participants
Interval 22.94 to 37.08
|
SECONDARY outcome
Timeframe: Up to 2 years from first study drug dose or up to final study visit, whichever occurs first, including but not limited to planned assessments scheduled approximately every 12 weeks.Population: ITT Population
CR is defined as disappearance of all detectable clinical evidence of disease (including cleared infiltrate on repeat bone marrow aspirate/biopsy if lymphoma involvement of bone marrow before treatment). Partial Response (PR) requires the following: 1. ≥50 % decrease in SPD of the six largest dominant nodes or nodal masses. 2. No increase in the size of other nodes, liver, or spleen. 3. Splenic and hepatic nodules must regress by ≥50% in the SPD, or for single nodules, in the greatest transverse diameter. 4. With the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. 5. No new sites of disease. unCR and unPR means didn't have confirmatory assessment (including bone marrow assessment for CR). The 95% CI was determined using the exact method based on binomial distribution.
Outcome measures
| Measure |
Inotuzumab Ozogamicin+Rituximab
n=166 Participants
Participants received rituximab 375 mg/m\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m\^2 via IV infusion on Day 2 of each 28-day cycle for a maximum of 6 cycles.
|
Rituximab+Gemcitabine or Rituximab+Bendamustine
n=172 Participants
Participants received either R-bendamustine (rituximab 375 mg/m\^2 via IV infusion on Day 1 and bendamustine 120 mg/m\^2 via IV infusion on Days 1 and 2 in 28-day cycles for a maximum of 6 cycles) or R-gemcitabine (rituximab 375 mg/m\^2 via IV infusion on Days 1, 8, 15 and 22 of Cycle 1 and on Day 1 for all other cycles, and gemcitabine 1000 mg/m\^2 via IV infusion on Days 1, 8 and 15 of each 28-day cycle for a maximum of 6 cycles). Choice of therapy was at the discretion of the investigator.
|
|---|---|---|
|
Percentage of Participants With A Best Overall Response of CR, Unconfirmed CR (unCR), PR, or Unconfirmed PR (unPR) Per NCI International Response Criteria for NHL
|
41.0 Percentage of Participants
Interval 33.4 to 48.85
|
43.6 Percentage of Participants
Interval 36.07 to 51.36
|
SECONDARY outcome
Timeframe: Up to 2 years from first study drug dose or up to final study visit, whichever occurs first, including but not limited to planned assessments scheduled approximately every 12 weeks.Population: ITT population; only participants with a CR, unCR, PR, or unPR were included in the analysis
The duration of overall response is measured from the first date of response until the first date that the progressive disease (PD) or death is objectively documented. The hazard ratio and corresponding 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.
Outcome measures
| Measure |
Inotuzumab Ozogamicin+Rituximab
n=166 Participants
Participants received rituximab 375 mg/m\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m\^2 via IV infusion on Day 2 of each 28-day cycle for a maximum of 6 cycles.
|
Rituximab+Gemcitabine or Rituximab+Bendamustine
n=172 Participants
Participants received either R-bendamustine (rituximab 375 mg/m\^2 via IV infusion on Day 1 and bendamustine 120 mg/m\^2 via IV infusion on Days 1 and 2 in 28-day cycles for a maximum of 6 cycles) or R-gemcitabine (rituximab 375 mg/m\^2 via IV infusion on Days 1, 8, 15 and 22 of Cycle 1 and on Day 1 for all other cycles, and gemcitabine 1000 mg/m\^2 via IV infusion on Days 1, 8 and 15 of each 28-day cycle for a maximum of 6 cycles). Choice of therapy was at the discretion of the investigator.
|
|---|---|---|
|
Duration of Response
|
11.56 Months
Interval 7.8 to
The upper limit of the 95 percent (%) confidence interval could not be determined due to the large number of censored events.
|
6.93 Months
Interval 5.5 to 10.8
|
SECONDARY outcome
Timeframe: Assessed at Day 1 of each cycle and 6-9 weeks after the last dose, Cycle 3 (Week 12) reportedPopulation: ITT population
EQ-5D consists of a descriptive system and an EQ visual analogue scale. The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The scale, the best state is marked 100 and the worst state is marked 0, is to help the participant to say how good or bad a health state is. EQ-5D index, which was reported, was derived based on US weight. The range of EQ-5D index is -0.109 to 1.00. Higher scores mean better outcomes. The average post-baseline scores for EQ-5D index were computed at approximately Week 12. The overall treatment comparisons were estimated at approximately Week 12.
Outcome measures
| Measure |
Inotuzumab Ozogamicin+Rituximab
n=166 Participants
Participants received rituximab 375 mg/m\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m\^2 via IV infusion on Day 2 of each 28-day cycle for a maximum of 6 cycles.
|
Rituximab+Gemcitabine or Rituximab+Bendamustine
n=172 Participants
Participants received either R-bendamustine (rituximab 375 mg/m\^2 via IV infusion on Day 1 and bendamustine 120 mg/m\^2 via IV infusion on Days 1 and 2 in 28-day cycles for a maximum of 6 cycles) or R-gemcitabine (rituximab 375 mg/m\^2 via IV infusion on Days 1, 8, 15 and 22 of Cycle 1 and on Day 1 for all other cycles, and gemcitabine 1000 mg/m\^2 via IV infusion on Days 1, 8 and 15 of each 28-day cycle for a maximum of 6 cycles). Choice of therapy was at the discretion of the investigator.
|
|---|---|---|
|
Health Status as Assessed by the European Quality of Life 5 Dimension (EQ-5D) Questionnaire
|
0.79 Unit on a scale
Interval 0.76 to 0.82
|
0.77 Unit on a scale
Interval 0.74 to 0.79
|
SECONDARY outcome
Timeframe: Assessed at Day 1 of each cycle and 6-9 weeks after the last dose, Cycle 3 (Week 12) reportedPopulation: ITT population
FACT-Lym is a questionnaire that begins with 27 items covering four core Health-Related Quality of Life subscales: Physical Well-being (7 items), Social/Family Well-being (7), Emotional Well-being (6), and Functional Well-being (7). The FACT-Lym also includes an additional concerns subscale (15 items). It also asks participants about their concerns about lumps and swelling, fevers, infections, weight, appetite, emotional stability and treatment. The participants were requested to circle one number on a 0 to 4 points scale per line to indicate how true each statement has been for him/her during the past 7 days. FACT-Lym total score, which was reported, was derived based on FACT-Lym scoring guideline (Version 4). The range of FACT-Lym total score is 0 to 168. Higher scores mean better outcomes. The average post-baseline FACT-Lym total scores were computed at approximately Week 12. The overall treatment comparisons were estimated at approximately Week 12.
Outcome measures
| Measure |
Inotuzumab Ozogamicin+Rituximab
n=166 Participants
Participants received rituximab 375 mg/m\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m\^2 via IV infusion on Day 2 of each 28-day cycle for a maximum of 6 cycles.
|
Rituximab+Gemcitabine or Rituximab+Bendamustine
n=172 Participants
Participants received either R-bendamustine (rituximab 375 mg/m\^2 via IV infusion on Day 1 and bendamustine 120 mg/m\^2 via IV infusion on Days 1 and 2 in 28-day cycles for a maximum of 6 cycles) or R-gemcitabine (rituximab 375 mg/m\^2 via IV infusion on Days 1, 8, 15 and 22 of Cycle 1 and on Day 1 for all other cycles, and gemcitabine 1000 mg/m\^2 via IV infusion on Days 1, 8 and 15 of each 28-day cycle for a maximum of 6 cycles). Choice of therapy was at the discretion of the investigator.
|
|---|---|---|
|
Health Related Quality of Life as Assessed by the Functional Assessment of Cancer Therapy for Lymphoma (FACT-Lym) Questionnaire
|
120.07 Unit on a scale
Interval 116.74 to 123.41
|
116.96 Unit on a scale
Interval 113.74 to 120.19
|
Adverse Events
Inotuzumab Ozogamicin+Rituximab
Serious events: 61 serious events
Other events: 155 other events
Deaths: 0 deaths
Rituximab+Gemcitabine or Rituximab+Bendamustine
Serious events: 63 serious events
Other events: 158 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Inotuzumab Ozogamicin+Rituximab
n=164 participants at risk
Participants received rituximab 375 mg/m\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m\^2 via IV infusion on Day 2 of each 28-day cycle for a maximum of 6 cycles.
|
Rituximab+Gemcitabine or Rituximab+Bendamustine
n=167 participants at risk
Participants received either R-bendamustine (rituximab 375 mg/m\^2 via IV infusion on Day 1 and bendamustine 120 mg/m\^2 via IV infusion on Days 1 and 2 in 28-day cycles for a maximum of 6 cycles) or R-gemcitabine (rituximab 375 mg/m\^2 via IV infusion on Days 1, 8, 15 and 22 of Cycle 1 and on Day 1 for all other cycles, and gemcitabine 1000 mg/m\^2 via IV infusion on Days 1, 8 and 15 of each 28-day cycle for a maximum of 6 cycles). Choice of therapy was at the discretion of the investigator.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.0%
5/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
4.2%
7/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.2%
2/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
1.2%
2/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome transformation
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Vascular disorders
Haematoma
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
1.8%
3/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
1.2%
2/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.2%
2/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Gastrointestinal disorders
Ileus
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
General disorders
Asthenia
|
1.8%
3/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
1.2%
2/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
General disorders
Disease progression
|
9.1%
15/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
12.0%
20/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
General disorders
Fatigue
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
General disorders
General physical health deterioration
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
General disorders
Oedema due to hepatic disease
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
General disorders
Pain
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
General disorders
Pyrexia
|
3.0%
5/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
2.4%
4/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
General disorders
Sudden death
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
2/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
1.2%
2/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Infections and infestations
Clostridium difficile infection
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Infections and infestations
Device related infection
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Infections and infestations
Infection
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Infections and infestations
Infectious pleural effusion
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Infections and infestations
Influenza
|
1.2%
2/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Infections and infestations
Lung infection
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Infections and infestations
Meningitis
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Infections and infestations
Pneumonia
|
4.9%
8/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Infections and infestations
Pyelonephritis
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Infections and infestations
Salmonella sepsis
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
1.2%
2/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Infections and infestations
Sinusitis
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Infections and infestations
Staphylococcal infection
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Infections and infestations
Staphylococcal skin infection
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
1.2%
2/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
1.2%
2/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Infections and infestations
Viral infection
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
1.2%
2/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
1.2%
2/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
1.2%
2/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Renal and urinary disorders
Renal failure
|
1.2%
2/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
1.2%
2/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Hepatobiliary disorders
Hepatitis
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Hepatobiliary disorders
Venoocclusive liver disease
|
1.2%
2/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.2%
2/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
1.2%
2/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
3/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.8%
3/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Nervous system disorders
Cognitive disorder
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Nervous system disorders
IIIrd nerve paralysis
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Nervous system disorders
Paraplegia
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Nervous system disorders
Presyncope
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Nervous system disorders
Tremor
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Psychiatric disorders
Delirium febrile
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.00%
0/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.61%
1/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
1.8%
3/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
0.60%
1/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
Other adverse events
| Measure |
Inotuzumab Ozogamicin+Rituximab
n=164 participants at risk
Participants received rituximab 375 mg/m\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m\^2 via IV infusion on Day 2 of each 28-day cycle for a maximum of 6 cycles.
|
Rituximab+Gemcitabine or Rituximab+Bendamustine
n=167 participants at risk
Participants received either R-bendamustine (rituximab 375 mg/m\^2 via IV infusion on Day 1 and bendamustine 120 mg/m\^2 via IV infusion on Days 1 and 2 in 28-day cycles for a maximum of 6 cycles) or R-gemcitabine (rituximab 375 mg/m\^2 via IV infusion on Days 1, 8, 15 and 22 of Cycle 1 and on Day 1 for all other cycles, and gemcitabine 1000 mg/m\^2 via IV infusion on Days 1, 8 and 15 of each 28-day cycle for a maximum of 6 cycles). Choice of therapy was at the discretion of the investigator.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
14.6%
24/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
25.7%
43/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
22.6%
37/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
32.3%
54/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
17.1%
28/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
23.4%
39/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
34.8%
57/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
48.5%
81/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
61.6%
101/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
38.3%
64/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.5%
9/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
2.4%
4/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.1%
10/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
10.2%
17/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.7%
6/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
6.0%
10/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.5%
14/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
7.8%
13/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
23.2%
38/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
19.8%
33/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.4%
22/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
18.6%
31/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
30.5%
50/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
32.3%
54/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
14.0%
23/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
19.2%
32/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
General disorders
Asthenia
|
7.9%
13/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
8.4%
14/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
General disorders
Chills
|
3.0%
5/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
5.4%
9/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
General disorders
Fatigue
|
33.5%
55/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
25.1%
42/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
General disorders
Oedema peripheral
|
10.4%
17/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
9.0%
15/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
General disorders
Pyrexia
|
22.6%
37/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
21.0%
35/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
5.5%
9/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
3.6%
6/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
5.5%
9/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
7.2%
12/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
17.1%
28/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
10.2%
17/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
26.8%
44/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
10.8%
18/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
14.6%
24/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
9.6%
16/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
6.1%
10/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
2.4%
4/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Investigations
Blood creatinine increased
|
3.0%
5/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
7.8%
13/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Investigations
Blood lactate dehydrogenase increased
|
5.5%
9/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
2.4%
4/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
23.2%
38/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
9.6%
16/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Investigations
Haemoglobin decreased
|
2.4%
4/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
6.0%
10/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Investigations
Platelet count decreased
|
5.5%
9/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
4.2%
7/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Investigations
Weight decreased
|
2.4%
4/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
6.6%
11/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Investigations
White blood cell count decreased
|
2.4%
4/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
7.2%
12/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
7.3%
12/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
1.8%
3/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
17.1%
28/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
18.6%
31/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
5.5%
9/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
3.6%
6/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.7%
11/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
8.4%
14/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
7.3%
12/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
7.2%
12/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Nervous system disorders
Dizziness
|
4.9%
8/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
7.8%
13/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
6.1%
10/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
4.8%
8/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Nervous system disorders
Headache
|
4.9%
8/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
6.6%
11/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
4.3%
7/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
5.4%
9/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.6%
24/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
7.8%
13/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.5%
9/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
8.4%
14/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.7%
6/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
6.0%
10/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.9%
8/164 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
7.8%
13/167 • Up to 22 weeks after the informed consent
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place