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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
This Phase Ib/II, open-label, multicenter trial is designed to evaluate the safety, pharmacokinetics, and efficacy of dulanermin when combined with rituximab in subjects with follicular, CD20+, B-cell Non-Hodgkin's Lymphoma (NHL) that has progressed following a response of ≥ 6 months duration to a prior rituximab-containing therapy. The multicenter, international, randomized Phase II part of this study will commence only after the safety and available pharmacokinetic data from the Phase Ib part of the study have been evaluated by the Sponsor and have been provided to participating investigators and the FDA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase Ib: Dulanermin 4 mg/kg | Experimental | Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses. |
|
| Phase Ib: Dulanermin 8 mg/kg | Experimental | Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses. |
|
| Phase II: Rituximab | Active Comparator | Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses. |
|
| Phase II: Combination Therapy | Experimental | Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dulanermin | Drug | Dulanermin was administered by intravenous (IV) infusion over 1 hour on days 1-5 of each 21-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase Ib: Number of Participants With a Dose-limiting Toxicity | A dose-limiting toxicity (DLT) was defined as a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0 Grade ≥ 3 hematologic or major organ toxicity that was related to study drug (i.e., dulanermin). Although a patient may have experienced a DLT at any time during the study, only events that occurred within the DLT assessment window were considered for dose-escalation decisions and determination of the maximum tolerated dose (MTD). | The DLT assessment window was defined as the duration required to complete two full cycles of treatment with dulanermin (2 * 21 days) and four doses of rituximab (usually through Day 28). |
| Number of Participants With Treatment-Emergent Adverse Events by Severity Grade | Safety was assessed through summaries of treatment-emergent adverse events (AEs); AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0, according to the following guidelines: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (Life-threatening or disabling) and Grade 5 (Death related to AE). | From Baseline through Study Termination (up to a maximum of approximately 13 months for phase Ib and up to approximately 33 months for phase II) |
| Phase II: Objective Response as Assessed by the Independent Review Facility (IRF) | Objective response was defined as a confirmed or unconfirmed complete response (CR, CRu) or partial response (PR) assessed on the basis of clinical, radiographic (computed tomography (CT) scans of the neck, chest, abdomen, pelvis and inguinal region), and pathologic (i.e., bone marrow) criteria and according to the modified International Working Group (IWG) criteria. All radiographic and clinical data for the evaluation of objective response were submitted to an IRF for blinded and impartial assessment. Patients without a post-baseline tumor assessment were considered non-responders. | From Baseline through Study Termination (up to approximately 33 months) |
| Vital Signs: Change From Baseline in Diastolic and Systolic Blood Pressure at Treatment Termination Visit |
| Measure | Description | Time Frame |
|---|---|---|
| Phase II: Progression Free Survival | Progression free survival (PFS) was defined as the time from randomization to documented disease progression or death, whichever occurred first and was based on the investigator's assessment using the modified IWG criteria. Kaplan-Meier methods were used to estimate median time to PFS. Data for patients without disease progression or death on study were censored at the time of the last tumor assessment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chia Portera, PhD., M.D | Genentech, Inc. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26687959 | Derived | Cheah CY, Belada D, Fanale MA, Janikova A, Czucman MS, Flinn IW, Kapp AV, Ashkenazi A, Kelley S, Bray GL, Holden S, Seymour JF. Dulanermin with rituximab in patients with relapsed indolent B-cell lymphoma: an open-label phase 1b/2 randomised study. Lancet Haematol. 2015 Apr;2(4):e166-74. doi: 10.1016/S2352-3026(15)00026-5. Epub 2015 Mar 25. |
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The Phase Ib part of this study was completed prior to the start of Phase II. Phase Ib participants were not eligible for participation in Phase II.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase Ib - Dulanermin 4 mg/kg | Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses. |
| FG001 | Phase Ib - Dulanermin 8 mg/kg | Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses. |
| FG002 | Phase II - Rituximab | Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses. |
| FG003 | Phase II - Combination Therapy | Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses. |
| FG004 | Phase II - Dulanermin | Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase Ib |
|
| |||||||||||||||||||||
| Phase II |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase Ib - Dulanermin 4 mg/kg | Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Age demographic data for the Phase Ib population. |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Phase Ib: Number of Participants With a Dose-limiting Toxicity | A dose-limiting toxicity (DLT) was defined as a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0 Grade ≥ 3 hematologic or major organ toxicity that was related to study drug (i.e., dulanermin). Although a patient may have experienced a DLT at any time during the study, only events that occurred within the DLT assessment window were considered for dose-escalation decisions and determination of the maximum tolerated dose (MTD). | The DLT-evaluable population consisted of all patients enrolled in the Phase Ib who received at least two complete cycles of dulanermin and four doses of rituximab and complete study assessments through the DLT Assessment Window without a DLT (usually through Day 28) or experienced a DLT and withdrew from the study within the DLT Assessment Window. | Posted | Number | participants | The DLT assessment window was defined as the duration required to complete two full cycles of treatment with dulanermin (2 * 21 days) and four doses of rituximab (usually through Day 28). |
|
Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
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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 | Phase Ib - Dulanermin 4 mg/kg | Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIARRHOEA | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
The Sponsor terminated the study on 5 May 2010, prior to the completion of the 36-month follow-up (FU) period, based on the primary analysis results. All patients were off-study or in survival FU (the treatment period was completed).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffman-LaRoche | 800-821-8590 |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| C505653 | TNFSF10 protein, human |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Phase II: Dulanermin | Experimental | Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. |
|
| Rituximab | Drug | Rituximab was administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses. |
|
Blood pressure was measured at baseline and throughout the study. Change from baseline was calculated using the patient's last recorded measurement at the completion of treatment visit - baseline measurement. |
| Baseline and Treatment Termination visit (8 weeks for Rituximab arm and 12 weeks for combination and Dulanermin arms) |
| Vital Signs: Change From Baseline in Heart Rate at Treatment Termination Visit | Heart rate was measured at baseline and throughout the study. Change from baseline was calculated using the patient's last recorded measurement at the completion of treatment visit - baseline measurement. | Baseline and Treatment Termination visit (8 weeks for Rituximab arm and 12 weeks for combination and Dulanermin arms) |
| Vital Signs: Change From Baseline in Body Temperature at Treatment Termination Visit | Body temperature was measured at baseline and throughout the study. Change from baseline was calculated using the patients last recorded measurement at the completion of treatment visit - baseline measurement. | Baseline and Treatment Termination visit (8 weeks for Rituximab arm and 12 weeks for combination and Dulanermin arms) |
| Number of Participants With a Clinically Significant Laboratory Abnormality | Laboratory Parameters were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). A clinically significant abnormality was defined as a Grade 3 (severe) or Grade 4 (very severe, life threatening, or disabling) laboratory toxicity according to the NCI CTCAE v3.0. | Baseline and Treatment Termination visit (8 weeks for Rituximab arm and 12 weeks for combination and Dulanermin arms). |
| Mean Serum Concentration of Dulanermin | The dulanermin serum concentration was measured using enzyme linked immunosorbent assay (ELISA). | Blood samples were taken 0.5, 1.5, 2, 3, 5, 7 and 24 hours after the start of the infusion on Day 1 of Cycle 1. |
| From Baseline through Study Termination (up to approximately 33 months) |
| Phase II: Overall Survival | Median overall survival could not be estimated because of the low number of deaths at the time of study termination. | From Baseline through Study Termination (up to approximately 33 months) |
| Phase II: Objective Response as Assessed by the Investigator | Objective response was defined as a confirmed or unconfirmed complete response(CR, CRu) or partial response (PR) assessed on the basis of clinical, radiographic (computed tomography (CT) scans of the neck, chest, abdomen, pelvis and inguinal region), and pathologic (i.e., bone marrow) criteria and according to the modified International Working Group (IWG) criteria. Patients without a post-baseline tumor assessment were considered non-responders. | From Baseline through Study Termination (up to approximately 33 months) |
| Phase II: Duration of Response as Assessed by the Investigator | An event was defined as documented disease progression or death on study, whichever occurred first. Duration of objective response was defined only for patients with an objective response as determined by the investigator and was the time from the initial response to disease progression or death on study. Kaplan-Meier methods were used to estimate median, percentiles, and range of duration of response. | From Baseline through Study Termination (up to approximately 33 months) |
| Death |
|
| Disease Progression |
|
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Phase Ib - Dulanermin 8 mg/kg |
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses. |
| BG002 | Phase II - Rituximab | Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses. |
| BG003 | Phase II - Combination Therapy | Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses. |
| BG004 | Phase II - Dulanermin | Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. |
| BG005 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Age, Customized | Age demographic data for the Phase II population. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 | Phase Ib - Dulanermin 4 mg/kg | Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses. |
| OG001 | Phase Ib - Dulanermin 8 mg/kg | Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses. |
|
|
| Primary | Number of Participants With Treatment-Emergent Adverse Events by Severity Grade | Safety was assessed through summaries of treatment-emergent adverse events (AEs); AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0, according to the following guidelines: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (Life-threatening or disabling) and Grade 5 (Death related to AE). | Safety Evaluable population, consisting of all randomized patients who received at least one dose of treatment. | Posted | Number | participants | From Baseline through Study Termination (up to a maximum of approximately 13 months for phase Ib and up to approximately 33 months for phase II) |
|
|
|
| Primary | Phase II: Objective Response as Assessed by the Independent Review Facility (IRF) | Objective response was defined as a confirmed or unconfirmed complete response (CR, CRu) or partial response (PR) assessed on the basis of clinical, radiographic (computed tomography (CT) scans of the neck, chest, abdomen, pelvis and inguinal region), and pathologic (i.e., bone marrow) criteria and according to the modified International Working Group (IWG) criteria. All radiographic and clinical data for the evaluation of objective response were submitted to an IRF for blinded and impartial assessment. Patients without a post-baseline tumor assessment were considered non-responders. | The phase II Efficacy-Evaluable population consisted of all randomized patients who received at least one dose of study treatment and had measurable disease at baseline, as assessed by the IRF. | Posted | Number | participants | From Baseline through Study Termination (up to approximately 33 months) |
|
|
|
| Primary | Vital Signs: Change From Baseline in Diastolic and Systolic Blood Pressure at Treatment Termination Visit | Blood pressure was measured at baseline and throughout the study. Change from baseline was calculated using the patient's last recorded measurement at the completion of treatment visit - baseline measurement. | Safety Evaluable population, consisting of all randomized patients who received at least one dose of treatment. | Posted | Mean | Standard Deviation | mmHg | Baseline and Treatment Termination visit (8 weeks for Rituximab arm and 12 weeks for combination and Dulanermin arms) |
|
|
|
| Primary | Vital Signs: Change From Baseline in Heart Rate at Treatment Termination Visit | Heart rate was measured at baseline and throughout the study. Change from baseline was calculated using the patient's last recorded measurement at the completion of treatment visit - baseline measurement. | Safety Evaluable population, consisting of all randomized patients who received at least one dose of treatment. | Posted | Mean | Standard Deviation | beats/minute | Baseline and Treatment Termination visit (8 weeks for Rituximab arm and 12 weeks for combination and Dulanermin arms) |
|
|
|
| Secondary | Phase II: Progression Free Survival | Progression free survival (PFS) was defined as the time from randomization to documented disease progression or death, whichever occurred first and was based on the investigator's assessment using the modified IWG criteria. Kaplan-Meier methods were used to estimate median time to PFS. Data for patients without disease progression or death on study were censored at the time of the last tumor assessment. | Safety-Evaluable population consisting of all randomized patients who received at least one dose of study treatment | Posted | Median | 95% Confidence Interval | months | From Baseline through Study Termination (up to approximately 33 months) |
|
|
|
| Secondary | Phase II: Overall Survival | Median overall survival could not be estimated because of the low number of deaths at the time of study termination. | Posted | Median | 95% Confidence Interval | months | From Baseline through Study Termination (up to approximately 33 months) |
|
|
| Secondary | Phase II: Objective Response as Assessed by the Investigator | Objective response was defined as a confirmed or unconfirmed complete response(CR, CRu) or partial response (PR) assessed on the basis of clinical, radiographic (computed tomography (CT) scans of the neck, chest, abdomen, pelvis and inguinal region), and pathologic (i.e., bone marrow) criteria and according to the modified International Working Group (IWG) criteria. Patients without a post-baseline tumor assessment were considered non-responders. | Safety Evaluable population, consisting of all randomized patients who received at least one dose of treatment. | Posted | Number | participants | From Baseline through Study Termination (up to approximately 33 months) |
|
|
|
| Secondary | Phase II: Duration of Response as Assessed by the Investigator | An event was defined as documented disease progression or death on study, whichever occurred first. Duration of objective response was defined only for patients with an objective response as determined by the investigator and was the time from the initial response to disease progression or death on study. Kaplan-Meier methods were used to estimate median, percentiles, and range of duration of response. | Safety-evaluable patients with an objective response determined by the Investigator. | Posted | Median | 95% Confidence Interval | months | From Baseline through Study Termination (up to approximately 33 months) |
|
|
|
| Primary | Vital Signs: Change From Baseline in Body Temperature at Treatment Termination Visit | Body temperature was measured at baseline and throughout the study. Change from baseline was calculated using the patients last recorded measurement at the completion of treatment visit - baseline measurement. | Safety Evaluable population, consisting of all randomized patients who received at least one dose of treatment. | Posted | Mean | Standard Deviation | degrees Celsius | Baseline and Treatment Termination visit (8 weeks for Rituximab arm and 12 weeks for combination and Dulanermin arms) |
|
|
|
| Primary | Number of Participants With a Clinically Significant Laboratory Abnormality | Laboratory Parameters were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). A clinically significant abnormality was defined as a Grade 3 (severe) or Grade 4 (very severe, life threatening, or disabling) laboratory toxicity according to the NCI CTCAE v3.0. | Safety Evaluable population consisting of all randomized patients who received at least one dose of study drug. | Posted | Number | participants | Baseline and Treatment Termination visit (8 weeks for Rituximab arm and 12 weeks for combination and Dulanermin arms). |
|
|
|
| Primary | Mean Serum Concentration of Dulanermin | The dulanermin serum concentration was measured using enzyme linked immunosorbent assay (ELISA). | Safety-evaluable population | Posted | Mean | Standard Deviation | µg/ml | Blood samples were taken 0.5, 1.5, 2, 3, 5, 7 and 24 hours after the start of the infusion on Day 1 of Cycle 1. |
|
|
|
| 1 |
| 6 |
| 6 |
| 6 |
| EG001 | Phase Ib - Dulanermin 8 mg/kg | Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses. | 1 | 6 | 6 | 6 |
| EG002 | Phase II - Rituximab | Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses. | 1 | 22 | 16 | 22 |
| EG003 | Phase II - Combination Therapy | Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses. | 4 | 26 | 22 | 26 |
| EG004 | Phase II - Dulanermin | Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. | 0 | 11 | 8 | 11 |
| CONSTIPATION | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| INFUSION RELATED REACTION | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| MYELODYSPLASTIC SYNDROME | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| ILEUS PARALYTIC | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| SEPSIS | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| DYSPHAGIA | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| ORAL PAIN | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| SENSITIVITY OF TEETH | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| STOMATITIS | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| TOOTHACHE | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| CHILLS | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| CATHETER SITE PAIN | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| CATHETER SITE ERYTHEMA | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| CATHETER SITE PRURITUS | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| FEELING COLD | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| GAIT DISTURBANCE | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| MUCOSAL INFLAMMATION | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| PAIN | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| SWELLING | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| HERNIA | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| NIGHT SWEATS | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| EXFOLIATIVE RASH | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| SKIN INDURATION | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| METABOLIC ACIDOSIS | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| FLUID RETENTION | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| PARAESTHESIA | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| SINUS HEADACHE | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| TREMOR | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| DYSGEUSIA | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| HYPOGEUSIA | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| SINUS CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| LUNG CONSOLIDATION | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| RESPIRATORY DISTRESS | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| RESPIRATORY TRACT CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| GROIN INFECTION | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| HERPES ZOSTER | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| ORAL HERPES | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| VIRAL INFECTION | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| RHINITIS | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| LIPASE INCREASED | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| BACTERIAL TEST POSITIVE | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| BLOOD AMYLASE INCREASED | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| HYPOTENSION | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| PHLEBITIS SUPERFICIAL | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| PHLEBITIS | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| NERVOUSNESS | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| NOCTURIA | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| COAGULOPATHY | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| DISSEMINATED INTRAVASCULAR COAGULATION | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| LEFT VENTRICULAR DYSFUNCTION | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| RIGHT VENTRICULAR DYSFUNCTION | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| DEAFNESS UNILATERAL | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| ADRENAL INSUFFICIENCY | Endocrine disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| DRY EYE | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| VISION BLURRED | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| HEPATIC FAILURE | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| CONTUSION | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| INCISION SITE PAIN | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| DRUG HYPERSENSITIVITY | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Grade 4 AE |
|
| Grade 3 AE |
|
| Grade 2 AE |
|
| Grade 1 AE |
|
| Any Grade AEs |
|
|
| Complete Response unconfirmed |
|
| Partial Response |
|
| Systolic Blood Pressure |
|
|
| Complete Response unconfirmed |
|
| Partial Response |
|
| 2 hours after the start of infusion |
|
| 3 hours after the start of infusion |
|
| 5 hours after the start of infusion |
|
| 7 hours after the start of infusion |
|
| 24 hours after the start of infusion |
|