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| ID | Type | Description | Link |
|---|---|---|---|
| Hx-CD20-409 | Other Identifier | Genmab | |
| The MUNIN trial |
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To investigate the efficacy in two dose regimens of ofatumumab in combination with CHOP (cyclophosphamide,doxorubicin, vincristine,prednisolone) in previously untreated patients with Follicular Lymphoma (FL)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Comparator 1 | Active Comparator | Each patient will receive a total of 6 infusions with ofatumumab in combination with CHOP every 3 weeks. The first infusion will be 300mg followed by 5 infusions of 500mg |
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| Active Comparator 2 | Active Comparator | Each patient will receive a total of 6 infusions with ofatumumab in combination with CHOP every 3 weeks. The first infusion will be 300mg followed by 5 infusions of 1000mg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ofatumumab | Drug | ofatumumab 300mg, 500mg or 1000mg should be diluted into 1000mL pyrogen free saline and administered as an IV infusion.Duration of infusion will be approximately 4 hours.Infusions should be given every 3 weeks until a total of 6 infusions has been given |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With the Indicated Overall Best Response (OBR) at Visit 26 (3 Months After the Last Infusion of Ofatumumab) | Based on standardized response criteria for NHL, responders included participants with CR (complete disappearance of all detectable clinical and radiographic evidence of disease), CRu (more than a 75% decrease in LN size compared to baseline), and PR (>=50% decrease in LN size and evidence of new lesions). Non-responders included participants with stable disease (SD; <50% decrease in LN size from baseline) and progressive disease (PD; >=50% increase in LN size and evidence of new lesions). | Maximum of 23 months after the start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Complete Remission (CR) at Visit 26 | Participants were evaluated for response by an Independent Endpoint Review Committee in accordance with the standardized response criteria for NHL. Participants with CR were defined as those with the complete disappearance of all detectable clinical and radiographic evidence of disease. | Maximum of 23 months after the start of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Buffalo | New York | 14263 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22409295 | Background | Czuczman MS, Hess G, Gadeberg OV, Pedersen LM, Goldstein N, Gupta I, Jewell RC, Lin TS, Lisby S, Strange C, Windfeld K, Viardot A; 409 Study Investigators. Chemoimmunotherapy with ofatumumab in combination with CHOP in previously untreated follicular lymphoma. Br J Haematol. 2012 May;157(4):438-45. doi: 10.1111/j.1365-2141.2012.09086.x. Epub 2012 Mar 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 500 mg Ofatumumab + CHOP | Ofatumumab was given on Day 1 and CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) on Day 3 of each 21-day cycle, with 300 milligrams (mg) in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Cyclophosphamide | Drug | Cyclophosphamide 750 mg/m2 iv for 1 day, 24-48h post-ofatumumab infusion start |
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| Doxorubicin | Drug | Doxorubicin : 50mg/m2 iv for 1 day, 24-48h post-ofatumumumab infusion start |
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| Vincristine | Drug | Vincristine : 1.4mg/m2 iv for 1 day, 24-48h post-ofatumumab infusion start |
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| Prednisolone, Prednisone or equivalent | Drug | 100mg p.o daily for 5 days, 24-48h post-ofatumumab infusion start |
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| Median Percent Change From Visit 1 (Screening, Week -2) in Tumor Size at Visit 33 (24 Months After the Last Infusion of Ofatumumab) | The tumor size for a participant was computed as the sum of product of diameters (SPD) for the indicator lesions. Reduction in tumor size was calculated as percent change from Visit 1 until Visit 33, separately by radiologist 1 and radiologist 2. Percent change from Visit 1 (Screening, Week -2) = (value at Visit 33 minus value at Visit 1 divided by value at Visit 1) * 100. | Maximum of 24 months after the last infusion of Ofatumumab (Visit 33; median of 33.8 months) |
| Time to New Anti-follicular Lymphoma (FL) Therapy | Time to new FL therapy is defined as the time from randomization until the time of first administration of the new FL therapy other than ofatumumab. Time to new FL therapy will be censored if participants are lost to follow-up. The censoring date in such cases will be the date of the last attended visit at which the endpoint was assessed. | Followed up to 5 years |
| Progression-Free Survival (PFS) | PFS is defined as the time from randomization until progression or death. | Followed up to 5 years |
| Duration of Response | The duration of response is defined as the time from the initial response (the first visit at which response was observed) to progression or death. | Followed up to 5 years |
| Percent Change From Visit 1 (Screening) in Peripheral CD19+ and CD20+ Cell Counts at Visit 33 (24 Months After the Last Infusion of Ofatumumab) | The peripheral blood for each participant was collected and analyzed for CD19+ and CD20+ cell counts. CD19+ and CD20+ are B-cell types which are used as an index of a participant's response to treatment. | Maximum of 24 months after the last infusion of Ofatumumab (Visit 33; median of 33.8 months) |
| Number of Participants Who Experienced Any Adverse Event (AEs) From First Treatment to Visit 33 (24 Months After Last Infusion) | An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. A list of AEs experienced in the study with a frequency threshold of 5% can be found in the AE section. | Up to 22 months after study start |
| Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Visits 1, 28, and 33 | HAHA are indicators of immunogenicity to ofatumumab. Blood samples were drawn from participants at Visits 1, 28, and 33 for analysis of HAHA. | Visits 1 (Screening), 28 (9 months after last dose), and 33 (24 months after last dose) |
| Median Percent Change From Visit 1 (Screening) in Serum Complement (CH50) Levels at Visit 22 | The peripheral blood for each participant was collected and analyzed for serum complement CH50 levels. Cluster of Differentiation index 50 (CD50) is a human gene which is used as an index of immune response. CD50Percent change from Visit 1 (Screening, Week -2) = (value at Visit 22 minus value at Visit 1 divided by value at Visit 1) * 100. | Visit 1 (Screening, Week -2) and Visit 22 (Week 15) |
| Number of Participants Who Had a Conversion of BCL-2 t(14;18)-Positive to Negative by Polymerase Chain Reaction (PCR) in Peripheral Blood and Bone Marrow Aspirate and Its Durability Post-therapy | This is a genetic prognostic marker of FL response. The former sponsor decided to not analyze these samples; therefore, no results are presented. | Maximum of 6 years follow-up |
| Cmax and Ctrough at the Sixth Infusion (Week 15, Visit 22) | Cmax is defined as the maximum concentration of drug in plasma samples. Ctrough is defined as the trough plasma concentration (measured concentration at the end of a dosing interval [taken directly before next administration]). | Week 15 (Visit 22) |
| AUC(0-inf) and AUC(0-504) After the Sixth Infusion (Week 15, Visit 22) | AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure. AUC(0-504) is AUC from the start of infusion to 504 hours after the start of the infusion; AUC(0-inf) is AUC from the start of infusion extrapolated to infinity. | Week 15 (Visit 22) |
| Half Life (t1/2) of Ofatumumab at the Sixth Infusion (Week 15, Visit 22) | Half life is defined as the period of time required for the amount of drug in the body to be reduced by half. | Week 15 (Visit 22) |
| CL After the Sixth Infusion (Week 15, Visit 22) | CL is the clearance of drug from plasma, which is defined as the volume of plasma from which the drug is cleared per unit time. | Week 15 (Visit 22) |
| Vss at the Sixth Infusion (Week 15, Visit 22) | Vss is defined as the volume of distribution at steady state of ofatumumab. | Week 15 (Visit 22) |
| FG001 | 1000 mg Ofatumumab + CHOP | Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study. |
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| ID | Title | Description |
|---|---|---|
| BG000 | 500 mg Ofatumumab + CHOP | Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study. |
| BG001 | 1000 mg Ofatumumab + CHOP | Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline characteristics were collected in the Full Analysis Set (FAS), comprised of all participants who were exposed to trial drug irrespective of their compliance to the planned course of treatment. One participant was enrolled and randomized to receive 1000 mg Ofatumumab + CHOP, but withdrew prior to initiation of therapy. | Mean | Standard Deviation | Years |
| ||||||||||||||
| Sex: Female, Male | Baseline characteristics were collected in the Full Analysis Set (FAS), comprised of all participants who were exposed to trial drug irrespective of their compliance to the planned course of treatment. One participant was enrolled and randomized to receive 1000 mg Ofatumumab + CHOP, but withdrew prior to initiation of therapy. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Baseline characteristics were collected in the Full Analysis Set (FAS), comprised of all participants who were exposed to trial drug irrespective of their compliance to the planned course of treatment. One participant was enrolled and randomized to receive 1000 mg Ofatumumab + CHOP, but withdrew prior to initiation of therapy. | 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Number of Participants With Complete Remission (CR) at Visit 26 | Participants were evaluated for response by an Independent Endpoint Review Committee in accordance with the standardized response criteria for NHL. Participants with CR were defined as those with the complete disappearance of all detectable clinical and radiographic evidence of disease. | FAS | Posted | Number | participants | Maximum of 23 months after the start of treatment |
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| Secondary | Median Percent Change From Visit 1 (Screening, Week -2) in Tumor Size at Visit 33 (24 Months After the Last Infusion of Ofatumumab) | The tumor size for a participant was computed as the sum of product of diameters (SPD) for the indicator lesions. Reduction in tumor size was calculated as percent change from Visit 1 until Visit 33, separately by radiologist 1 and radiologist 2. Percent change from Visit 1 (Screening, Week -2) = (value at Visit 33 minus value at Visit 1 divided by value at Visit 1) * 100. | FAS. Participants were withdrawn from the study between Visits 1 and 33. | Posted | Median | Full Range | Percent change in tumor size | Maximum of 24 months after the last infusion of Ofatumumab (Visit 33; median of 33.8 months) |
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| Secondary | Time to New Anti-follicular Lymphoma (FL) Therapy | Time to new FL therapy is defined as the time from randomization until the time of first administration of the new FL therapy other than ofatumumab. Time to new FL therapy will be censored if participants are lost to follow-up. The censoring date in such cases will be the date of the last attended visit at which the endpoint was assessed. | FAS | Posted | Median | 95% Confidence Interval | months | Followed up to 5 years |
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| Secondary | Progression-Free Survival (PFS) | PFS is defined as the time from randomization until progression or death. | FAS | Posted | Median | 95% Confidence Interval | months | Followed up to 5 years |
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| Secondary | Duration of Response | The duration of response is defined as the time from the initial response (the first visit at which response was observed) to progression or death. | FAS. Only those participants with a response were analyzed. | Posted | Median | 95% Confidence Interval | months | Followed up to 5 years |
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| Secondary | Percent Change From Visit 1 (Screening) in Peripheral CD19+ and CD20+ Cell Counts at Visit 33 (24 Months After the Last Infusion of Ofatumumab) | The peripheral blood for each participant was collected and analyzed for CD19+ and CD20+ cell counts. CD19+ and CD20+ are B-cell types which are used as an index of a participant's response to treatment. | FAS. Only those participants who provided samples at Visit 33 were analyzed. | Posted | Median | Full Range | Percent change in cell counts | Maximum of 24 months after the last infusion of Ofatumumab (Visit 33; median of 33.8 months) |
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| Secondary | Number of Participants Who Experienced Any Adverse Event (AEs) From First Treatment to Visit 33 (24 Months After Last Infusion) | An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. A list of AEs experienced in the study with a frequency threshold of 5% can be found in the AE section. | FAS | Posted | Number | participants | Up to 22 months after study start |
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| Secondary | Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Visits 1, 28, and 33 | HAHA are indicators of immunogenicity to ofatumumab. Blood samples were drawn from participants at Visits 1, 28, and 33 for analysis of HAHA. | FAS. Participants dropped out of the study as the study progressed. | Posted | Number | participants | Visits 1 (Screening), 28 (9 months after last dose), and 33 (24 months after last dose) |
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| Secondary | Median Percent Change From Visit 1 (Screening) in Serum Complement (CH50) Levels at Visit 22 | The peripheral blood for each participant was collected and analyzed for serum complement CH50 levels. Cluster of Differentiation index 50 (CD50) is a human gene which is used as an index of immune response. CD50Percent change from Visit 1 (Screening, Week -2) = (value at Visit 22 minus value at Visit 1 divided by value at Visit 1) * 100. | FAS. Only those participants who remained in the study at Visit 22 were analyzed. | Posted | Median | Full Range | Percent change in serum complement CH50 | Visit 1 (Screening, Week -2) and Visit 22 (Week 15) |
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| Primary | Number of Participants With the Indicated Overall Best Response (OBR) at Visit 26 (3 Months After the Last Infusion of Ofatumumab) | Based on standardized response criteria for NHL, responders included participants with CR (complete disappearance of all detectable clinical and radiographic evidence of disease), CRu (more than a 75% decrease in LN size compared to baseline), and PR (>=50% decrease in LN size and evidence of new lesions). Non-responders included participants with stable disease (SD; <50% decrease in LN size from baseline) and progressive disease (PD; >=50% increase in LN size and evidence of new lesions). | FAS | Posted | Number | participants | Maximum of 23 months after the start of treatment |
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| Secondary | Number of Participants Who Had a Conversion of BCL-2 t(14;18)-Positive to Negative by Polymerase Chain Reaction (PCR) in Peripheral Blood and Bone Marrow Aspirate and Its Durability Post-therapy | This is a genetic prognostic marker of FL response. The former sponsor decided to not analyze these samples; therefore, no results are presented. | FAS | Posted | Maximum of 6 years follow-up |
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| Secondary | Cmax and Ctrough at the Sixth Infusion (Week 15, Visit 22) | Cmax is defined as the maximum concentration of drug in plasma samples. Ctrough is defined as the trough plasma concentration (measured concentration at the end of a dosing interval [taken directly before next administration]). | FAS. Data were provided for the number of participants who had a value. Participants withdrawn during the study were not analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | milligrams per liter (mg/L) | Week 15 (Visit 22) |
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| Secondary | AUC(0-inf) and AUC(0-504) After the Sixth Infusion (Week 15, Visit 22) | AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure. AUC(0-504) is AUC from the start of infusion to 504 hours after the start of the infusion; AUC(0-inf) is AUC from the start of infusion extrapolated to infinity. | FAS. Data were provided for the number of participants for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Milligrams * hours/liter (mg.h/L) | Week 15 (Visit 22) |
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| Secondary | Half Life (t1/2) of Ofatumumab at the Sixth Infusion (Week 15, Visit 22) | Half life is defined as the period of time required for the amount of drug in the body to be reduced by half. | FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Week 15 (Visit 22) |
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| Secondary | CL After the Sixth Infusion (Week 15, Visit 22) | CL is the clearance of drug from plasma, which is defined as the volume of plasma from which the drug is cleared per unit time. | FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Milliliters per hour (mL/h) | Week 15 (Visit 22) |
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| Secondary | Vss at the Sixth Infusion (Week 15, Visit 22) | Vss is defined as the volume of distribution at steady state of ofatumumab. | FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters | Week 15 (Visit 22) |
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Non-serious adverse events (AEs) were collected from the start of study medication until Follow-up (up to 24 months after last treatment). Serious AEs were collected from the start of study medication until study completion (up to 60 months).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 500 mg Ofatumumab + CHOP | Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study. | 13 | 29 | 29 | 29 | ||
| EG001 | 1000 mg Ofatumumab + CHOP | Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study. | 11 | 29 | 28 | 29 | ||
| EG002 | 500 mg Ofatumumab + CHOP: Extended Follow-up | Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study. | 1 | 29 | 0 | 29 | ||
| EG003 | 1000 mg Ofatumumab + CHOP: Extended Follow-up | Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study. | 6 | 29 | 0 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Peritonitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Small intestinal perforation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA | Systematic Assessment |
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| Injection site extravasation | General disorders | MedDRA | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
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| Lung infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Candidiasis | Infections and infestations | MedDRA | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Ovarian cyst | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
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| Cytokine release syndrome | Immune system disorders | MedDRA | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA | Systematic Assessment |
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| Disease progression | General disorders | MedDRA | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Precancerous skin lesion | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Rosacea | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Periostitis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA | Systematic Assessment |
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| Iliostomy | Surgical and medical procedures | MedDRA | Systematic Assessment |
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| Abnorminal hernia | General disorders | MedDRA | Systematic Assessment |
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| Fibula Fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Meniscus injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Erysipelas | Infections and infestations | MedDRA | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Vulval Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Infarction (CNS) | Vascular disorders | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
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| Infusion related reaction | General disorders | MedDRA | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
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| Oedema | General disorders | MedDRA | Systematic Assessment |
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| Chills | General disorders | MedDRA | Systematic Assessment |
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| Pain | General disorders | MedDRA | Systematic Assessment |
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| Asthenia | General disorders | MedDRA | Systematic Assessment |
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| Mucosal inflammation | General disorders | MedDRA | Systematic Assessment |
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| Chest pain | General disorders | MedDRA | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Gingivitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Hemorrhoids | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Aphthous stomatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Glossodynia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Gingival bleeding | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Polyneuropathy | Nervous system disorders | MedDRA | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | MedDRA | Systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MedDRA | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Nasal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hematoma | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA | Systematic Assessment |
| |
| Keratoconjuntivitis sicca | Eye disorders | MedDRA | Systematic Assessment |
| |
| Ocular surface disease | Eye disorders | MedDRA | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Inconsistence | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| 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 |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D014750 | Vincristine |
| D011239 | Prednisolone |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011244 | Pregnadienediols |
Not provided
Not provided
| Male |
|
| Hispanic or Latino |
|
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