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It is a non-interventional study with a duration of approximately 24 months per participant to investigate the therapeutic efficiency, safety and treatment regimens of Rituximab maintenance therapy in daily routine in participants with previously untreated, relapsed or refractory cluster of differentiation 20 (CD20)-positive follicular lymphoma (FL) in clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First-line Stratum | Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition. |
| |
| Relapsed/Refractory Stratum | Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Were Alive and Free From Progressive Disease | Progressive Disease is defined as at least a 20 percent (%) increase in the sum of the longest diameter of target lesions, taking) as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Median Progression Free Survival (PFS) Time | PFS was defined as the time from the date of the first cycle to the first occurrence of progression of tumor or death from any reason (whichever occurred first). If progression or death was not observed during the study, progression-free survival time was censored by the last documented tumor assessment during the maintenance therapy (latest at the end of study after two years). Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions. PFS was assessed using Kaplan-Meier estimate. |
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Inclusion Criteria:
Exclusion Criteria:
Not Applicable (NA)
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Participants with follicular lymphoma who are to be treated with Rituximab in the maintenance dosing period as decided by the physician
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Essen | 45122 | Germany |
Fifteen out of 505 participants were screen failure and excluded from the baseline and safety data sets. Safety Set Overall (SSO) included 490 participants who received at least 1 dose of study drug in/during the maintenance period. Therapy line was not reported for 1 participant and participant flow was reported for 489 participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | First-line Stratum | Participants who were untreated and decided by the treating physician to be treated with Rituximab for the cluster of differentiation (CD) 20-positive follicular lymphoma condition, were observed for a maximum of 2 years. |
| FG001 | Relapsed/Refractory Stratum | Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Reduced Safety Set Overall (rSSO): Included participants who received at least 1 dose of study drug during the maintenance therapy with adequate completion of documentation (primary data lock).
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| ID | Title | Description |
|---|---|---|
| BG000 | First-line Stratum | Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years. |
| BG001 | Relapsed/Refractory Stratum |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Participants Who Were Alive and Free From Progressive Disease | Progressive Disease is defined as at least a 20 percent (%) increase in the sum of the longest diameter of target lesions, taking) as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions. | Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy. | Posted | Number | 95% Confidence Interval | percentage of participants | 2 years |
|
2 years
SSO, 1 participant was excluded as no therapy line was reported and serious adverse events data was reported for 489 participants. rSSO was used for reporting non-serious adverse events.
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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 | First-line Stratum | Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800-821-8590 | genentech@druginfo.com |
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| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 2 years |
| Percentage of Participants Who Were Alive | Death for any reason was regarded as an event. Percentage of participants who were alive after 2 years of maintenance therapy with Rituximab was reported. | 2 years |
| Median Overall Survival (OS) Time | Survival was the interval of time from date of first dose of study medication to date of death at any time. Participants who had not died were censored at the date of last contact when they were known to be alive. OS was assessed using Kaplan-Meier estimate. | 2 years |
| Percentage of Participants With Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Progressive Disease [PD] at the End of Maintenance Therapy | CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR is defined as at least a 30 percentage (%) decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. PD is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions. | 2 years |
| Percentage of Participants With Best Overall Response | The percentage of participants was presented with respect to the best overall response (CR, PR, SD). CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. | 2 years |
| Percentage of Participants With Initiation of New Therapy | Percentage of participants for whom new therapy was initiated at the end of maintenance therapy was reported. | 2 years |
| Death due to lymphoma |
|
| Death due to other reason |
|
| Intolerability |
|
| Withdrawal by Subject |
|
| Other |
|
| Missing |
|
Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Relapsed/Refractory Stratum | Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years. |
|
|
| Secondary | Median Progression Free Survival (PFS) Time | PFS was defined as the time from the date of the first cycle to the first occurrence of progression of tumor or death from any reason (whichever occurred first). If progression or death was not observed during the study, progression-free survival time was censored by the last documented tumor assessment during the maintenance therapy (latest at the end of study after two years). Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions. PFS was assessed using Kaplan-Meier estimate. | Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy. | Posted | Median | 95% Confidence Interval | months | 2 years |
|
|
|
| Secondary | Percentage of Participants Who Were Alive | Death for any reason was regarded as an event. Percentage of participants who were alive after 2 years of maintenance therapy with Rituximab was reported. | Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy. | Posted | Number | 95% Confidence Interval | percentage of participants | 2 years |
|
|
|
| Secondary | Median Overall Survival (OS) Time | Survival was the interval of time from date of first dose of study medication to date of death at any time. Participants who had not died were censored at the date of last contact when they were known to be alive. OS was assessed using Kaplan-Meier estimate. | Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy. | Posted | Median | 95% Confidence Interval | months | 2 years |
|
|
|
| Secondary | Percentage of Participants With Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Progressive Disease [PD] at the End of Maintenance Therapy | CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR is defined as at least a 30 percentage (%) decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. PD is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions. | Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy. | Posted | Number | percentage of participants | 2 years |
|
|
|
| Secondary | Percentage of Participants With Best Overall Response | The percentage of participants was presented with respect to the best overall response (CR, PR, SD). CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. | Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy. | Posted | Number | 95% Confidence Interval | percentage of participants | 2 years |
|
|
|
| Secondary | Percentage of Participants With Initiation of New Therapy | Percentage of participants for whom new therapy was initiated at the end of maintenance therapy was reported. | Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy. | Posted | Number | percentage of participants | 2 years |
|
|
|
| 35 |
| 312 |
| 0 |
| 310 |
| EG001 | Relapsed/Refractory Stratum | Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years. | 39 | 177 | 30 | 173 |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Atrioventricular block | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Cardiovascular disorder | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Colitis microscopic | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Tongue coated | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Death | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Ill-defined disorder | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Performance status disorder | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Bile duct stenosis | Hepatobiliary disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Liver injury | Hepatobiliary disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Immunodeficiency | Immune system disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Haemophilus sepsis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Atypical pneumonia | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Bronchitis bacterial | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Infectious colitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Rotavirus infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
|
| B-lymphocyte count decreased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
|
| Blast cells present | Investigations | MedDRA (17.0) | Non-systematic Assessment |
|
| Carbohydrate antigen 15-3 increased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA (17.0) | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| B-cell lymphoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
|
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
|
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
|
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
|
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
|
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
|
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
|
| Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (17.0) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Alveolitis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Pleural fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Hospitalisation | Surgical and medical procedures | MedDRA (17.0) | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Shock haemorrhagic | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Shock | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Bacterial Infection | Infections and infestations | MedDRA (17.0) | Non-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.
| D008232 |
| Lymphoproliferative Disorders |
| 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 |
| SD |
|
| PD |
|
| Yes |
|