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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-004177-17 | EudraCT Number | ||
| COMB157E2301 | Other Identifier | Novartis |
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The study was terminated early as it did not meet the Primary efficacy objective after primary analysis.
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The purpose of this study was to evaluate the safety and efficacy of ofatumumab and bendamustine combination therapy in patients with indolent B-cell NHL that did not respond to rituximab or a rituximab-containing regimen during or within 6 months of the last rituximab treatment.
Ofatumumab is an anti-CD20 monoclonal antibody shown to have monotherapy activity in patients with follicular lymphoma that has relapsed following rituximab-containing therapy. Bendamustine was approved by FDA for the treatment of in patients with indolent B-cell Non-Hodgkin's Lymphoma (NHL) that did not respond to rituximab or a rituximab-containing regimen during or within 6 months of the last rituximab treatment.
Biologics have demonstrated enhanced efficacy when added to chemotherapeutic combinations in the frontline treatment for indolent NHL. The combination of ofatumumab and bendamustine may provide additional clinical benefit and efficacy to those who no longer respond to rituximab or rituximab-containing regimens.
The objective of this study is to determine the effect of ofatumumab and bendamustine combination therapy in patients with indolent B-cell NHL that did not respond to rituximab or a rituximab-containing regimen during or within 6 months of the last rituximab treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ofatumumab and Bendamustine (Arm A) | Experimental | Up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and q28 days when given as monotherapy) |
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| Bendamustine (Arm B) | Active Comparator | Up to 8 cycles of bendamustine (120 mg/m2) on Days 1,2 every 21 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ofatumumab | Drug | Ofatumumab was a liquid concentrate solution for infusion presented in glass vials containing 50 mL of solution at a concentration of 20 mg/mL to provide 1000 mg per vial. The ofatumumab infusions were prepared in 1000 mL sterile, pyrogen-free 0.9% NaCl to yield a 1 mg/mL ofatumumab concentration infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC) | PFS is defined as the time interval between randomization until disease progression or death (due to any cause). | From randomization to the date of first documented disease progression or death due to any cause (67.5 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) in Participants With Follicular Lymphoma (FL) Per IRC | PFS is defined as the time interval between randomization until disease progression or death (due to any cause). | From randomization to the date of first documented disease progression or death due to any cause (67.5 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Tucson | Arizona | 85715 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33973233 | Derived | Rummel MJ, Janssens A, MacDonald D, Keating MM, Zaucha JM, Davis J, Lasher J, Babanrao Pisal C, Izquierdo M, Friedberg JW. A phase 3, randomized study of ofatumumab combined with bendamustine in rituximab-refractory iNHL (COMPLEMENT A + B study). Br J Haematol. 2021 Jun;193(6):1123-1133. doi: 10.1111/bjh.17420. Epub 2021 May 10. |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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| ID | Title | Description |
|---|---|---|
| FG000 | Ofa + Benda (Arm A) | ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days |
| FG001 | Benda (Arm B) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Phase - no Optional Ofa |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 13, 2017 | Dec 24, 2019 |
randomized open label bendamustine monotherapy vs. ofatumumab
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| Bendamustine infusion | Drug | Bendamustine 100 mg/vial, injection |
|
| Ofatumumab and Bendamustine infusions (Arm A) | Drug | Up to 8 cycles of Bendamustine (90 mg/m2 Days 1 and 2, every 21 days) given in combination with 12 doses of ofatumumab (1000 mg). Ofatumumab will be given on day 1 of each cycle of bendamustine as long as patients in Arm A receive bendamustine. Once patients in Arm A complete bendamustine therapy, the remaining doses of ofatumumab will be given monthly until all 12 doses are completed. |
|
| Bendamustine infusion (Arm B) | Drug | Bendamustine (120 mg/m2 Days 1 and 2, every 21 days, up to 8 cycles). |
|
| Overall Response Rate (ORR) in All Participants Per IRC |
ORR: Percentage of subjects achieving complete response (CR) or partial response (PR) from the start of randomization until disease progression or the start of new anti-cancer therapy, including the optional ofatumumab for subjects in Arm B based on responses from the IRC assessment of best overall response using the Revised Response Criteria for Malignant Lymphoma (RRCML). Response criteria is CR, PR, standard disease (SD), progressive disease (PD) or not estimable. CR is the complete disappearance of all detectable clinical evidence of disease & disease-related symptoms. PR is at least a 50% decrease from baseline in the sum of the product of the diameters (SPD) of target lesions. SD is failure to attain the criteria needed for a CR, PR or PD. PD is the appearance of any new lesion more than 1.5 cm in any axis or at least a 50% increase from nadir in the SPD of target or non target lesions or at least a 50% increase in the longest diameter(SLD) or any Target or non target lesions. |
| From randomization until the 217th PFS event occurred, up to about 67.5 months |
| Overall Response Rate (ORR) in Participants With FL Per IRC | ORR: Percentage of subjects achieving complete response (CR) or partial response (PR) from the start of randomization until disease progression or the start of new anti-cancer therapy, including the optional ofatumumab for subjects in Arm B based on responses from the IRC assessment of best overall response using the Revised Response Criteria for Malignant Lymphoma (RRCML). Response criteria is CR, PR, standard disease (SD), progressive disease (PD) or not estimable. CR is the complete disappearance of all detectable clinical evidence of disease & disease-related symptoms. PR is at least a 50% decrease from baseline in the sum of the product of the diameters (SPD) of target lesions. SD is failure to attain the criteria needed for a CR, PR or PD. PD is the appearance of any new lesion more than 1.5 cm in any axis or at least a 50% increase from nadir in the SPD of target or non target lesions or at least a 50% increase in the longest diameter(SLD) or any Target or non target lesions. | From randomization until the 217th PFS event occurred, up to about 67.5 months |
| Overall Survival (OS) in All Participants | The interval of time between the date of randomization and the date of death due to any cause. For subjects who are alive, time of death will be censored at the date of last contact. | From randomization up to about 89 months |
| Overall Survival (OS) in Participants With FL | The interval of time between the date of randomization and the date of death due to any cause. For subjects who are alive, time of death will be censored at the date of last contact. | From randomization up to about 89 months |
| Time to Response in All Participants Per IRC | Time to response = time from randomization to the first response (CR/ PR). If no CR/PR value was present data was to be censored at last adequate assessment. | From randomization to up to 67.5 months |
| Time to Response in Participants With FL Per IRC | Time to response = time from randomization to the first response (CR/ PR). If no CR/PR value was present data was to be censored at last adequate assessment. | From randomization to up to 67.5 months |
| Duration of Response in All Participants Per IRC | Time (in months) from the initial response (CR/PR) to first documented sign of disease progression or death due to any cause. | time from the initial response (CR/PR) (Day 84) to first documented sign of disease progression or death due to any cause up to 67.5 months |
| Duration of Response in Participants With FL Per IRC | Time (in months) from the initial response (CR/PR) to first documented sign of disease progression or death due to any cause. | time from the initial response (CR/PR) (Day 84) to first documented sign of disease progression or death due to any cause up to 67.5 months |
| Time to Progression in All Participants Per IRC | Time from randomization until disease progression | From randomization to the date of first documented disease progression, whichever occurred first, reported betwen day of first participant randomized up to about 67.5 months |
| Time to Progression in Participants With FL Per IRC | Time from randomization until disease progression | From randomization to the date of first documented disease progression, whichever occurred first, reported betwen day of first participant randomized up to about 67.5 months |
| Time to Next Therapy in All Participants Per IRC | Time to next therapy was defined as the time (in months) from randomization date to the date of receiving the next line treatment, including all therapy types. | from randomization date to the date of receiving the next line treatment or death, up to 67.5 months |
| Time to Next Therapy in Participants With FL Per IRC | Time to next therapy was defined as the time (in months) from randomization date to the date of receiving the next line treatment, including all therapy types | from randomization date to the date of receiving the next line treatment or death, up to 67.5 months |
| PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym | The Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) is intended as a lymphoma specific additional concerns subscale that is designed to supplement the FACT-G. The subscale consists of 15 items. Subjects respond to the items on a five point Likert scale ranging from 0 'Not at all' to 4 'Very much'. Subscale scores are calculated by summing individual items to obtain a score, then multiplying the sum of the item scores by the number of items in the subscale, then dividing by the number of items answered. The Score range is 0 -28 for Physical Well-Being, Social/Family Well-Being, 0 -24 for Functional Well-Being and 0 - 60 for the Lymphoma subscale (LYMS). FACT lymphoma TOI is the sum of Physical, Functional Well-Being & Lymphoma scores. FACT-G Total Score is the sum of Physical, Emotional, Social and Functional Well-Being scores. FACT-Lymph is the sum of Physical, Social, Emotional, Functional and Lymphoma scores. The higher the score, the better the QOL. C =cycle; D=Day | administered at the screening visit and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days |
| PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym | The Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) is intended as a lymphoma specific additional concerns subscale that is designed to supplement the FACT-G. The subscale consists of 15 items. Subjects respond to the items on a five point Likert scale ranging from 0 'Not at all' to 4 'Very much'. Subscale scores are calculated by summing individual items to obtain a score, then multiplying the sum of the item scores by the number of items in the subscale, then dividing by the number of items answered. The Score range is 0 -28 for Physical Well-Being, Social/Family Well-Being, 0 -24 for Functional Well-Being and 0 - 60 for the Lymphoma subscale (LYMS). FACT lymphoma TOI is the sum of Physical, Functional Well-Being & Lymphoma scores. FACT-G Total Score is the sum of Physical, Emotional, Social and Functional Well-Being scores. FACT-Lymph is the sum of Physical, Social, Emotional, Functional and Lymphoma scores. The higher the score, the better the QOL. C =cycle; D=Day | administered at the screeing visit and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days |
| PRO - Change From Baseline in HRQL Measures in All Participants: The EQ-5D | The EuroQoL Five-Dimension (EQ-5D) is a self-administered, generic, indirect utility measure used for health economic analysis.EQ-5D should be answered as one of 3 levels about current condition for 5 dimensions and was calculated total average by giving a weighting on 3 level of answers (EQ-5D levels into 'no problems' (level 1) and 'problems' (level 2 and 3)). Table of scores by each level for EQ-5D items: mobility(level 1=0, level2=0.069,level 3=0.314), self care(level 1=0, level2=0.104,level 3=0.214), usual activities(level 1=0, level2=0.036,level 3=0.094), pain/discomfort (level 1=0, level2=0.,level 3=0.386) and anxiety/depression(level 1=0, level2=0.071,level 3=0.2) *EQ-5D Total = 1 - 0.081 - (the score of the each level) - 0.269 (if at least one of level 3 presents) | administered at screening and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days |
| PRO - Change From Baseline in HRQL Measures in Participants With FL: The EQ-5D | The EuroQoL Five-Dimension (EQ-5D) is a self-administered, generic, indirect utility measure used for health economic analysis.EQ-5D should be answered as one of 3 levels about current condition for 5 dimensions and was calculated total average by giving a weighting on 3 level of answers (EQ-5D levels into 'no problems' (level 1) and 'problems' (level 2 and 3)). Table of scores by each level for EQ-5D items: mobility(level 1=0, level2=0.069,level 3=0.314), self care(level 1=0, level2=0.104,level 3=0.214), usual activities(level 1=0, level2=0.036,level 3=0.094), pain/discomfort (level 1=0, level2=0.,level 3=0.386) and anxiety/depression(level 1=0, level2=0.071,level 3=0.2) *EQ-5D Total = 1 - 0.081 - (the score of the each level) - 0.269 (if at least one of level 3 presents) | administered at screening and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days |
| PRO - Change in Health Treatment in HRQL Measures in All Participants: The Health Change Questionnaire (HCQ) | The Health Change Questionnaire,(HCQ) used is a nine item scale that asks the patient to rate change in status since beginning treatment on this study. For HCQ, values from 1 to 9 were assigned to the 9 responses in the HCQ questionnaire, ranging from 1 for 'my health is a great deal better' to 9 for 'my health is a great deal worse' since the beginning of the study. Lower scores represent better conditions | administered at screening and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days |
| PRO - Change in Health Treatment in HRQL Measures in Participants With FL: The Health Change Questionnaire (HCQ) | The Health Change Questionnaire, (HCQ) used is a nine item scale that asks the patient to rate change in status since beginning treatment on this study. For HCQ, values from 1 to 9 were assigned to the 9 responses in the HCQ questionnaire, ranging from 1 for 'my health is a great deal better' to 9 for 'my health is a great deal worse' since the beginning of the study. Lower scores represent better conditions | administered at screening and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days |
| Reduction in Tumor Size | Tumor size was measured by the mean change in the sum of the products of the greatest diameter (SPD) of the largest abnormal nodes from baseline to post-baseline by CT Scan. | baseline, post-baseline (up to 55 months) |
| Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status | This is the number of participants with change in ECOG status. Change is measured categorically by "Improvement, deterioration and No change". Improvement is defined as decrease from baseline by at least one step on the ECOG performance status scale. Deteriorations is defined as increase from baseline by at least one step on the ECOG performance status scale. ECOG status to evaluate daily living: 0: Fully active, able to carry on all pre-disease performance without restriction; 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2: Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4: Completely disabled; cannot carry on any self care.Totally confined to bed or chai; 5: Dead | administered at screening and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days |
| Summary of Number of Participants With Human Anti-Human Antibodies (HAHA) | A summary by responders and non-responders | From randomization up to about 67.5 months |
| Overall Response Rate (ORR) to Optional Ofatumumab Monotherapy in Subjects Who Progressed During or Following Single-agent Bendamustine | ORR: Percentage of subjects achieving complete response (CR) or partial response (PR) from the start of randomization until disease progression or the start of new anti-cancer therapy, including the optional ofatumumab for subjects in Arm B based on responses from the IRC assessment of best overall response using the Revised Response Criteria for Malignant Lymphoma (RRCML). Response criteria is CR, PR, standard disease (SD), progressive disease (PD) or not estimable. CR is the complete disappearance of all detectable clinical evidence of disease & disease-related symptoms. PR is at least a 50% decrease from baseline in the sum of the product of the diameters (SPD) of target lesions. SD is failure to attain the criteria needed for a CR, PR or PD. PD is the appearance of any new lesion more than 1.5 cm in any axis or at least a 50% increase from nadir in the SPD of target or non target lesions or at least a 50% increase in the longest diameter(SLD) or any Target or non target lesions. | From randomization until the 217th PFS event occurred, up to about 67.8 months |
| Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM) | at scheduled visits for actual values as well as for change from baseline | Screening, C1D1, 1M post D252, 6M post D252, 12M post D252 up to 67.5 months; Cycle = 21 days |
| Plasma Ofatumumab Concentrations | Concentrations of ofatumumab in plasma listed by actual relative time and summarized by nominal time. | C1D1, C7D1, C12D1, C1D1, C12D1, 12M post-D252, withdrawal up to 12 months follow up |
| B-cell Monitoring (CD19+, CD20+) | The percent change of CD5+CD19+ and CD5-CD19+ from baseline was summarized to assess the treatment effect, to monitor the normal B-cell population, and to follow their recovery. | C5D1 (month 5), 1M post-D252, 9M post-D252, up to 67.5 months; Cycle = 21 days |
| Human Anti-chimeric Antibodies (HACA) Over Time | The number of participants with positive and negative baseline HACA results | At Baseline and Cycle 1 day 1 |
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| Novartis Investigative Site | Volgograd | 400138 | Russia |
| Novartis Investigative Site | Bratislava | 833 10 | Slovakia |
| Novartis Investigative Site | Kyiv | 03022 | Ukraine |
| Novartis Investigative Site | Lviv | 79044 | Ukraine |
| Novartis Investigative Site | Makiivka | 86132 | Ukraine |
| Novartis Investigative Site | Plymouth | Devon | PL68DH | United Kingdom |
| Novartis Investigative Site | Northwood | Middlesex | HA6 2RN | United Kingdom |
| Novartis Investigative Site | Harrow | HA1 3UJ | United Kingdom |
| Novartis Investigative Site | Southampton | SO16 6YD | United Kingdom |
| Novartis Investigative Site | Uxbridge | UB8 3NN | United Kingdom |
Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days |
| FG002 | Optional Ofa | Participants from the Benda arm who opted for optional ofatumumab therapy post disease progression. |
| Completed 5-year Follow-up |
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| Safety Population |
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| COMPLETED |
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| NOT COMPLETED |
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| Optional Ofa Phase |
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Intent-to-Treat (ITT):
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ofa + Benda (Arm A) | ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days |
| BG001 | Benda (Arm B) | Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| FLIPI-1 Score at Screening | Follicular Lymphoma International Prognostic Index-1 (FLIPI) is a prognostic tool that may be used to evaluate & select treatments based on differences in survival between risk groups. Low: (0 - 1) corresponds to better survival rate; intermediate: 2, corresponds to intermediate survival rate & high: (>=3) corresponds to worse survival rate. This index uses parameters related to subject characteristics such as age, tumor burden (Ann Arbor stage, number of nodal sites), tumor aggressiveness (serum Lactate Dehydrogenase (LDH) level), & consequences of the lymphoma on the host (hemoglobin level). | Number | participants |
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| Baseline Absolute Lymphocyte Count (ALC) | LLN - equal to the 5th percentile of a healthy, non-smoking population | Number | Participants |
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| Fc Gamma Receptor (FcR) Gamma 3A Variation | Number | Participants |
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| Human Anti-Chimeric Antibodies (HACA) | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC) | PFS is defined as the time interval between randomization until disease progression or death (due to any cause). | ITT: The Intent-to-Treat (ITT) population included subjects who were randomized in the study. | Posted | Median | 95% Confidence Interval | months | From randomization to the date of first documented disease progression or death due to any cause (67.5 months) |
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| Secondary | Progression-free Survival (PFS) in Participants With Follicular Lymphoma (FL) Per IRC | PFS is defined as the time interval between randomization until disease progression or death (due to any cause). | Subjects in ITT with Follicular Lymphoma (FL). ITT population included subjects who were randomized in the study. | Posted | Median | 95% Confidence Interval | months | From randomization to the date of first documented disease progression or death due to any cause (67.5 months) |
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| Secondary | Overall Response Rate (ORR) in All Participants Per IRC | ORR: Percentage of subjects achieving complete response (CR) or partial response (PR) from the start of randomization until disease progression or the start of new anti-cancer therapy, including the optional ofatumumab for subjects in Arm B based on responses from the IRC assessment of best overall response using the Revised Response Criteria for Malignant Lymphoma (RRCML). Response criteria is CR, PR, standard disease (SD), progressive disease (PD) or not estimable. CR is the complete disappearance of all detectable clinical evidence of disease & disease-related symptoms. PR is at least a 50% decrease from baseline in the sum of the product of the diameters (SPD) of target lesions. SD is failure to attain the criteria needed for a CR, PR or PD. PD is the appearance of any new lesion more than 1.5 cm in any axis or at least a 50% increase from nadir in the SPD of target or non target lesions or at least a 50% increase in the longest diameter(SLD) or any Target or non target lesions. | ITT: The ITT population included subjects who were randomized in the study. | Posted | Number | 95% Confidence Interval | Percentage of participants | From randomization until the 217th PFS event occurred, up to about 67.5 months |
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| Secondary | Overall Response Rate (ORR) in Participants With FL Per IRC | ORR: Percentage of subjects achieving complete response (CR) or partial response (PR) from the start of randomization until disease progression or the start of new anti-cancer therapy, including the optional ofatumumab for subjects in Arm B based on responses from the IRC assessment of best overall response using the Revised Response Criteria for Malignant Lymphoma (RRCML). Response criteria is CR, PR, standard disease (SD), progressive disease (PD) or not estimable. CR is the complete disappearance of all detectable clinical evidence of disease & disease-related symptoms. PR is at least a 50% decrease from baseline in the sum of the product of the diameters (SPD) of target lesions. SD is failure to attain the criteria needed for a CR, PR or PD. PD is the appearance of any new lesion more than 1.5 cm in any axis or at least a 50% increase from nadir in the SPD of target or non target lesions or at least a 50% increase in the longest diameter(SLD) or any Target or non target lesions. | Subjects in ITT with FL. ITT population included subjects who were randomized in the study. | Posted | Number | 95% Confidence Interval | Percentage of participants | From randomization until the 217th PFS event occurred, up to about 67.5 months |
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| Secondary | Overall Survival (OS) in All Participants | The interval of time between the date of randomization and the date of death due to any cause. For subjects who are alive, time of death will be censored at the date of last contact. | ITT: The ITT population included subjects who were randomized in the study. | Posted | Median | 95% Confidence Interval | months | From randomization up to about 89 months |
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| Secondary | Overall Survival (OS) in Participants With FL | The interval of time between the date of randomization and the date of death due to any cause. For subjects who are alive, time of death will be censored at the date of last contact. | Subjects in ITT with FL. ITT population included subjects who were randomized in the study. | Posted | Median | 95% Confidence Interval | months | From randomization up to about 89 months |
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| Secondary | Time to Response in All Participants Per IRC | Time to response = time from randomization to the first response (CR/ PR). If no CR/PR value was present data was to be censored at last adequate assessment. | ITT: The ITT population included subjects who were randomized in the study. | Posted | Median | 95% Confidence Interval | Months | From randomization to up to 67.5 months |
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| Secondary | Time to Response in Participants With FL Per IRC | Time to response = time from randomization to the first response (CR/ PR). If no CR/PR value was present data was to be censored at last adequate assessment. | Subjects in ITT with FL. ITT population included subjects who were randomized in the study. | Posted | Median | 95% Confidence Interval | Months | From randomization to up to 67.5 months |
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| Secondary | Duration of Response in All Participants Per IRC | Time (in months) from the initial response (CR/PR) to first documented sign of disease progression or death due to any cause. | ITT: The ITT population included subjects who were randomized in the study. | Posted | Median | 95% Confidence Interval | months | time from the initial response (CR/PR) (Day 84) to first documented sign of disease progression or death due to any cause up to 67.5 months |
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| Secondary | Duration of Response in Participants With FL Per IRC | Time (in months) from the initial response (CR/PR) to first documented sign of disease progression or death due to any cause. | Subjects in ITT with FL. ITT population included subjects who were randomized in the study. | Posted | Median | 95% Confidence Interval | months | time from the initial response (CR/PR) (Day 84) to first documented sign of disease progression or death due to any cause up to 67.5 months |
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| Secondary | Time to Progression in All Participants Per IRC | Time from randomization until disease progression | ITT: The ITT population included subjects who were randomized in the study. | Posted | Median | 95% Confidence Interval | Months | From randomization to the date of first documented disease progression, whichever occurred first, reported betwen day of first participant randomized up to about 67.5 months |
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| Secondary | Time to Progression in Participants With FL Per IRC | Time from randomization until disease progression | Subjects in ITT with FL. ITT population included subjects who were randomized in the study. | Posted | Median | 95% Confidence Interval | Months | From randomization to the date of first documented disease progression, whichever occurred first, reported betwen day of first participant randomized up to about 67.5 months |
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| Secondary | Time to Next Therapy in All Participants Per IRC | Time to next therapy was defined as the time (in months) from randomization date to the date of receiving the next line treatment, including all therapy types. | ITT: The ITT population included subjects who were randomized in the study. | Posted | Median | 95% Confidence Interval | Months | from randomization date to the date of receiving the next line treatment or death, up to 67.5 months |
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| Secondary | Time to Next Therapy in Participants With FL Per IRC | Time to next therapy was defined as the time (in months) from randomization date to the date of receiving the next line treatment, including all therapy types | Subjects in ITT with FL. ITT population included subjects who were randomized in the study. | Posted | Median | 95% Confidence Interval | Months | from randomization date to the date of receiving the next line treatment or death, up to 67.5 months |
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| Secondary | PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym | The Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) is intended as a lymphoma specific additional concerns subscale that is designed to supplement the FACT-G. The subscale consists of 15 items. Subjects respond to the items on a five point Likert scale ranging from 0 'Not at all' to 4 'Very much'. Subscale scores are calculated by summing individual items to obtain a score, then multiplying the sum of the item scores by the number of items in the subscale, then dividing by the number of items answered. The Score range is 0 -28 for Physical Well-Being, Social/Family Well-Being, 0 -24 for Functional Well-Being and 0 - 60 for the Lymphoma subscale (LYMS). FACT lymphoma TOI is the sum of Physical, Functional Well-Being & Lymphoma scores. FACT-G Total Score is the sum of Physical, Emotional, Social and Functional Well-Being scores. FACT-Lymph is the sum of Physical, Social, Emotional, Functional and Lymphoma scores. The higher the score, the better the QOL. C =cycle; D=Day | ITT: The ITT population included subjects who were randomized in the study. | Posted | Mean | Standard Deviation | scores on a scale | administered at the screening visit and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days |
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| Secondary | PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym | The Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) is intended as a lymphoma specific additional concerns subscale that is designed to supplement the FACT-G. The subscale consists of 15 items. Subjects respond to the items on a five point Likert scale ranging from 0 'Not at all' to 4 'Very much'. Subscale scores are calculated by summing individual items to obtain a score, then multiplying the sum of the item scores by the number of items in the subscale, then dividing by the number of items answered. The Score range is 0 -28 for Physical Well-Being, Social/Family Well-Being, 0 -24 for Functional Well-Being and 0 - 60 for the Lymphoma subscale (LYMS). FACT lymphoma TOI is the sum of Physical, Functional Well-Being & Lymphoma scores. FACT-G Total Score is the sum of Physical, Emotional, Social and Functional Well-Being scores. FACT-Lymph is the sum of Physical, Social, Emotional, Functional and Lymphoma scores. The higher the score, the better the QOL. C =cycle; D=Day | Subjects in ITT with FL. ITT population included subjects who were randomized in the study. | Posted | Mean | Standard Deviation | scores on a scale | administered at the screeing visit and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days |
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| Secondary | PRO - Change From Baseline in HRQL Measures in All Participants: The EQ-5D | The EuroQoL Five-Dimension (EQ-5D) is a self-administered, generic, indirect utility measure used for health economic analysis.EQ-5D should be answered as one of 3 levels about current condition for 5 dimensions and was calculated total average by giving a weighting on 3 level of answers (EQ-5D levels into 'no problems' (level 1) and 'problems' (level 2 and 3)). Table of scores by each level for EQ-5D items: mobility(level 1=0, level2=0.069,level 3=0.314), self care(level 1=0, level2=0.104,level 3=0.214), usual activities(level 1=0, level2=0.036,level 3=0.094), pain/discomfort (level 1=0, level2=0.,level 3=0.386) and anxiety/depression(level 1=0, level2=0.071,level 3=0.2) *EQ-5D Total = 1 - 0.081 - (the score of the each level) - 0.269 (if at least one of level 3 presents) | ITT: The ITT population included subjects who were randomized in the study. | Posted | Mean | Standard Deviation | scores on a scale | administered at screening and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days |
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| Secondary | PRO - Change From Baseline in HRQL Measures in Participants With FL: The EQ-5D | The EuroQoL Five-Dimension (EQ-5D) is a self-administered, generic, indirect utility measure used for health economic analysis.EQ-5D should be answered as one of 3 levels about current condition for 5 dimensions and was calculated total average by giving a weighting on 3 level of answers (EQ-5D levels into 'no problems' (level 1) and 'problems' (level 2 and 3)). Table of scores by each level for EQ-5D items: mobility(level 1=0, level2=0.069,level 3=0.314), self care(level 1=0, level2=0.104,level 3=0.214), usual activities(level 1=0, level2=0.036,level 3=0.094), pain/discomfort (level 1=0, level2=0.,level 3=0.386) and anxiety/depression(level 1=0, level2=0.071,level 3=0.2) *EQ-5D Total = 1 - 0.081 - (the score of the each level) - 0.269 (if at least one of level 3 presents) | Subjects in ITT with FL. ITT population included subjects who were randomized in the study. | Posted | Mean | Standard Deviation | scores on a scale | administered at screening and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days |
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| Secondary | PRO - Change in Health Treatment in HRQL Measures in All Participants: The Health Change Questionnaire (HCQ) | The Health Change Questionnaire,(HCQ) used is a nine item scale that asks the patient to rate change in status since beginning treatment on this study. For HCQ, values from 1 to 9 were assigned to the 9 responses in the HCQ questionnaire, ranging from 1 for 'my health is a great deal better' to 9 for 'my health is a great deal worse' since the beginning of the study. Lower scores represent better conditions | ITT: The ITT population included subjects who were randomized in the study. | Posted | Mean | Standard Deviation | scores on a scale | administered at screening and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days |
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| Secondary | PRO - Change in Health Treatment in HRQL Measures in Participants With FL: The Health Change Questionnaire (HCQ) | The Health Change Questionnaire, (HCQ) used is a nine item scale that asks the patient to rate change in status since beginning treatment on this study. For HCQ, values from 1 to 9 were assigned to the 9 responses in the HCQ questionnaire, ranging from 1 for 'my health is a great deal better' to 9 for 'my health is a great deal worse' since the beginning of the study. Lower scores represent better conditions | Subjects in ITT with FL. ITT population included subjects who were randomized in the study. | Posted | Mean | Standard Deviation | scores on a scale | administered at screening and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days |
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| Secondary | Reduction in Tumor Size | Tumor size was measured by the mean change in the sum of the products of the greatest diameter (SPD) of the largest abnormal nodes from baseline to post-baseline by CT Scan. | ITT: The ITT population included subjects who were randomized in the study. | Posted | Mean | Standard Deviation | mm^2 | baseline, post-baseline (up to 55 months) |
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| Secondary | Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status | This is the number of participants with change in ECOG status. Change is measured categorically by "Improvement, deterioration and No change". Improvement is defined as decrease from baseline by at least one step on the ECOG performance status scale. Deteriorations is defined as increase from baseline by at least one step on the ECOG performance status scale. ECOG status to evaluate daily living: 0: Fully active, able to carry on all pre-disease performance without restriction; 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2: Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4: Completely disabled; cannot carry on any self care.Totally confined to bed or chai; 5: Dead | ITT: The ITT population included subjects who were randomized in the study. | Posted | Number | participants | administered at screening and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days |
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| Secondary | Summary of Number of Participants With Human Anti-Human Antibodies (HAHA) | A summary by responders and non-responders | Safety: The Safety population included all subjects who received at least one dose of a study drug. Per protocol, HAHA was only collected for subjects in the Ofa+benda arm. | Posted | Number | Participants | From randomization up to about 67.5 months |
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| Secondary | Overall Response Rate (ORR) to Optional Ofatumumab Monotherapy in Subjects Who Progressed During or Following Single-agent Bendamustine | ORR: Percentage of subjects achieving complete response (CR) or partial response (PR) from the start of randomization until disease progression or the start of new anti-cancer therapy, including the optional ofatumumab for subjects in Arm B based on responses from the IRC assessment of best overall response using the Revised Response Criteria for Malignant Lymphoma (RRCML). Response criteria is CR, PR, standard disease (SD), progressive disease (PD) or not estimable. CR is the complete disappearance of all detectable clinical evidence of disease & disease-related symptoms. PR is at least a 50% decrease from baseline in the sum of the product of the diameters (SPD) of target lesions. SD is failure to attain the criteria needed for a CR, PR or PD. PD is the appearance of any new lesion more than 1.5 cm in any axis or at least a 50% increase from nadir in the SPD of target or non target lesions or at least a 50% increase in the longest diameter(SLD) or any Target or non target lesions. | ITT: The ITT population included subjects who were randomized in the study. | Posted | Number | Percentage of participants | From randomization until the 217th PFS event occurred, up to about 67.8 months |
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| Secondary | Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM) | at scheduled visits for actual values as well as for change from baseline | Safety: The Safety population included all subjects who received at least one dose of a study drug (Ofa+benda arm only). | Posted | Mean | Standard Deviation | g/L | Screening, C1D1, 1M post D252, 6M post D252, 12M post D252 up to 67.5 months; Cycle = 21 days |
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| Secondary | Plasma Ofatumumab Concentrations | Concentrations of ofatumumab in plasma listed by actual relative time and summarized by nominal time. | Pharmacokinetic Population: The Pharmacokinetic Population included all subjects who provided at least one evaluable PK concentration | Posted | Mean | Standard Deviation | ug/mL | C1D1, C7D1, C12D1, C1D1, C12D1, 12M post-D252, withdrawal up to 12 months follow up |
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| Secondary | B-cell Monitoring (CD19+, CD20+) | The percent change of CD5+CD19+ and CD5-CD19+ from baseline was summarized to assess the treatment effect, to monitor the normal B-cell population, and to follow their recovery. | ITT: The ITT population included subjects who were randomized in the study. | Posted | Mean | Standard Deviation | percentage change from baseline | C5D1 (month 5), 1M post-D252, 9M post-D252, up to 67.5 months; Cycle = 21 days |
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| Secondary | Human Anti-chimeric Antibodies (HACA) Over Time | The number of participants with positive and negative baseline HACA results | Safety: The Safety population included all subjects who received at least one dose of a study drug | Posted | Number | Participants | At Baseline and Cycle 1 day 1 |
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Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 60 days, up to maximum duration of 367 days.
AE: Any sign or symptom that occurs during the study treatment plus up to 60 days post treatment
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ofa + Benda (Arm A) | ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days | 66 | 172 | 72 | 172 | 158 | 172 |
| EG001 | Benda (Arm B) | Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days | 71 | 170 | 84 | 170 | 162 | 170 |
| EG002 | Optional Ofa | Eligible benda arm participants who were offered optional ofatumumab following disease progression | 15 | 32 | 8 | 32 | 21 | 32 |
| EG003 | Ofa + Benda (Arm A) + Benda (Arm B) + Optional Ofa | All participants in the Ofa + Benda arm and in the Benda only arm | 137 | 342 | 160 | 342 | 320 | 342 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
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| Aplastic anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
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| Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
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| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
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| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
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| Thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
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| Acute coronary syndrome | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
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| Cardiac failure chronic | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
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| Cardio-respiratory arrest | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
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| Cardiopulmonary failure | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
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| Left ventricular dysfunction | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Optic atrophy | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Retinal artery occlusion | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Duodenal perforation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Faecalith | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hepatorenal syndrome | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Type IV hypersensitivity reaction | Immune system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal sepsis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Acinetobacter bacteraemia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Cytomegalovirus chorioretinitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Dysentery | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Herpes ophthalmic | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Herpes zoster disseminated | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Neutropenic infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumocystis jirovecii infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumonia cytomegaloviral | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Postoperative abscess | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Progressive multifocal leukoencephalopathy | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Spinal cord infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Staphylococcal skin infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Cytomegalovirus test positive | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Adenocarcinoma pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Benign ovarian tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Burkitt's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Myelofibrosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Paraparesis | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vascular encephalopathy | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abnormal behaviour | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Urinary tract inflammation | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pulmonary thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Paraneoplastic pemphigus | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Toxic epidermal necrolysis | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Loss of personal independence in daily activities | Social circumstances | MedDRA (19.0) | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Aortic aneurysm rupture | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Subclavian vein thrombosis | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
As the primary endpoint of the study was not met, secondary efficacy endpoints were not fully tested. The data being reported is for information only and not intended to be inferential.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 23, 2018 | Dec 24, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C527517 | ofatumumab |
Not provided
Not provided
Not provided
| Withdrawal by Subject |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| 3 - 5 |
|
| Missing |
|
| >= LLN |
|
| Missing |
|
| TG |
|
| TT |
|
| Missing |
|
| Positive |
|
| Missing |
|
|
|
Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days |
|
|
|
| Benda (Arm B) |
Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| OG001 | Benda (Arm B) | Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days |
|
|
| OG001 | Benda (Arm B) | Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days |
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Benda (Arm B) |
Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days |
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
|