Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007-002532-28 | EudraCT Number |
Not provided
Not provided
Study terminated due to slow enrollment.
Not provided
Not provided
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This is a Phase II, single-arm, open-label, multinational, multicenter study of rATG in patients with low or intermediate-1 risk MDS who have either failed 1 prior treatment with growth factor(s), hypomethylating agents (5-azacitidine or decitabine), or the antiangiogenic agents lenalidomide or thalidomide, or who have never been treated for MDS (i.e., treatment-naïve patients).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thymoglobulin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thymoglobulin®, Rabbit Anti-thymocyte Globulin (rATG) | Biological | All patients were to be treated with rATG 3.75 mg/kg/day administered by intravenous (IV) infusion over ≥6 hours for 5 consecutive days (cumulative dose: 18.75 mg/kg) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieved Hematologic Improvement (HI) | This is a measure of HI in the erythroid, platelet, and neutrophil lineages. Note that HI was observed in the erythroid lineage only, which is defined as a participant who had a >=1.5 g/dL increase in hemoglobin from baseline (pretreatment value must have been <11 g/dL) and who had a relevant reduction of units of red blood cell (RBC) transfusions by an absolute number of >=4 RBC transfusions over 8 weeks as compared with the pretreatment transfusion number in the previous 8 weeks. These criteria were taken from the 2006 International Working Group criteria. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Duration of HI | This is a measure of the duration of HI for those participants who achieved HI. Duration of HI is defined as the time from confirmation of HI response to the date of first documentation of HI relapse or death due to any cause, whichever occurs first. | 36 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Genzyme, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Avicenne/University | Paris | 93009 | France | |||
| St. Johannes-Hospital Duisburg |
Because the study was terminated early due to slow enrollment, only 16 participants were enrolled in the study. Of these, 14 participants went on to receive treatment with Thymoglobulin.
Enrollment period: 05 November 2007 through 06 May 2009. Study participants were enrolled at 7 study centers in Europe.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Thymoglobulin | Thymoglobulin 3.75 mg/kg/day for 5 consecutive days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Number of Participants Who Achieved Disease Remission |
Disease remission is defined as a participant whose best response to therapy was a complete remission or partial remission. A complete remission is defined as: bone marrow <=5% myeloblasts with normal maturation of all cell lines; persistent dysplasia noted; and peripheral blood hemoglobin >=11 g/dL, platelets >=100 x 10^9/L, neutrophils >=1.0 x 10^9/L, and blasts 0%. Partial remission is defined as: all complete remission criteria if abnormal before treatment, except bone marrow blasts decreased by >=50% over pretreatment, but still >5%; and cellularity and morphology not relevant. |
| 36 months |
| Duration of Disease Remission | This is a measure of the duration of overall disease remission only for those participants who achieved an overall remission. Duration of overall remission is defined as the time from first documentation of overall remission to the date of first documentation of disease relapse or death due to any cause, whichever occurs first. | 36 months |
| Number of Participants Who Achieved Transfusion Independence | This is a measure of transfusion independence, which is defined as a participant with no transfusions for a period of 8 consecutive calendar weeks after first dose. Transfusion independence was to be calculated only for those participants who had documented transfusions during the 8 weeks prior to enrollment. | 36 months |
| Number of Participants With Duration of Transfusion Independence | This is a measure of the duration of transfusion independence only for those participants who achieved transfusion independence. Duration of transfusion independence is defined as the longest period of time during which a participant requires no transfusions. | 36 months |
| Number of Participants With a Relapse Following HI | This is a measure of relapse following HI, which is defined as a participant who experiences at least one of the following: >=50% decrease from maximum response levels in granulocytes or platelets; >=1.5 g/dL reduction in hemoglobin; or transfusion dependence. | 36 months |
| Number of Participants With a Relapse Following Overall Remission | This is a measure of relapse following an overall remission only for participants who experienced either a complete or partial remission. Relapse following an overall remission is defined as a participant who meets any of the following criteria: a return to pretreatment bone marrow blast percentage; decrease of >=50% from maximum remission levels in neutrophils or platelets; reduction in hemoglobin concentration by >=1.5 g/dL from maximum remission levels; or transfusion dependence. | 36 months |
| Number of Participants With Progression-free Survival | This is a measure of a progression-free survival which is defined as the time from the participant's first dose to the date of disease progression, lost to follow-up or death due to any cause, whichever occurs first. | 36 months |
| Number of Participants With Transformation to Acute Myeloid Leukemia | This is a measure of transformation to acute myeloid leukemia only for participants who have bone marrow assessments. Transformation to acute myeloid leukemia is defined as the earliest date a participant experiences bone marrow blasts of >=20% after the start of treatment. | 36 months |
| Number of Participants With a Cytogenetic Response | This is a measure of cytogenic response for participants whose best response to therapy is a either a complete or partial cytogenetic response. A complete cytogenetic response is defined as the disappearance of the chromosomal abnormality without appearance of new ones. A partial cytogenetic response is defined as at least 50% reduction of the chromosomal abnormality. | 36 months |
| Number of Participants With a Marrow Remission | This is a measure of bone marrow complete remission for participants who experience a remission. Bone marrow complete remission is defined as a bone marrow assessment of <=5% myeloblasts and decrease by >=50% over pretreatment. | 36 months |
| Duisburg |
| 47166 |
| Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| UMC St Radboud Centraal | Nijmegen | 6525 GA | Netherlands |
| Royal Bournemouth Hospital | Bournemouth | England | BH7 7DW | United Kingdom |
| St. James Hospital | Leeds | England | LS9 7TF | United Kingdom |
| King's College Hospital | London | England | SE5 9RS | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Thymoglobulin | Thymoglobulin 3.75 mg/kg/day for 5 consecutive days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Age, Customized | Number | participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
|
| 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 | Number of Participants Who Achieved Hematologic Improvement (HI) | This is a measure of HI in the erythroid, platelet, and neutrophil lineages. Note that HI was observed in the erythroid lineage only, which is defined as a participant who had a >=1.5 g/dL increase in hemoglobin from baseline (pretreatment value must have been <11 g/dL) and who had a relevant reduction of units of red blood cell (RBC) transfusions by an absolute number of >=4 RBC transfusions over 8 weeks as compared with the pretreatment transfusion number in the previous 8 weeks. These criteria were taken from the 2006 International Working Group criteria. | Number of participants analyzed includes those who received treatment with Thymoglobulin and completed follow-up efficacy assessments. However, no formal efficacy analysis was conducted due to the small sample size and early study termination. | Posted | Number | participants | 12 months |
|
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Duration of HI | This is a measure of the duration of HI for those participants who achieved HI. Duration of HI is defined as the time from confirmation of HI response to the date of first documentation of HI relapse or death due to any cause, whichever occurs first. | This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point). | Posted | 36 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Achieved Disease Remission | Disease remission is defined as a participant whose best response to therapy was a complete remission or partial remission. A complete remission is defined as: bone marrow <=5% myeloblasts with normal maturation of all cell lines; persistent dysplasia noted; and peripheral blood hemoglobin >=11 g/dL, platelets >=100 x 10^9/L, neutrophils >=1.0 x 10^9/L, and blasts 0%. Partial remission is defined as: all complete remission criteria if abnormal before treatment, except bone marrow blasts decreased by >=50% over pretreatment, but still >5%; and cellularity and morphology not relevant. | This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point). | Posted | 36 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Duration of Disease Remission | This is a measure of the duration of overall disease remission only for those participants who achieved an overall remission. Duration of overall remission is defined as the time from first documentation of overall remission to the date of first documentation of disease relapse or death due to any cause, whichever occurs first. | This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point). | Posted | 36 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Achieved Transfusion Independence | This is a measure of transfusion independence, which is defined as a participant with no transfusions for a period of 8 consecutive calendar weeks after first dose. Transfusion independence was to be calculated only for those participants who had documented transfusions during the 8 weeks prior to enrollment. | This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point). | Posted | 36 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Duration of Transfusion Independence | This is a measure of the duration of transfusion independence only for those participants who achieved transfusion independence. Duration of transfusion independence is defined as the longest period of time during which a participant requires no transfusions. | This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point). | Posted | 36 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With a Relapse Following HI | This is a measure of relapse following HI, which is defined as a participant who experiences at least one of the following: >=50% decrease from maximum response levels in granulocytes or platelets; >=1.5 g/dL reduction in hemoglobin; or transfusion dependence. | This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point). | Posted | 36 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With a Relapse Following Overall Remission | This is a measure of relapse following an overall remission only for participants who experienced either a complete or partial remission. Relapse following an overall remission is defined as a participant who meets any of the following criteria: a return to pretreatment bone marrow blast percentage; decrease of >=50% from maximum remission levels in neutrophils or platelets; reduction in hemoglobin concentration by >=1.5 g/dL from maximum remission levels; or transfusion dependence. | Secondary outcome measure was not formally analyzed or assessed due to early study termination and small sample size (i.e., no study participants reached the 36-month time point) | Posted | 36 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Progression-free Survival | This is a measure of a progression-free survival which is defined as the time from the participant's first dose to the date of disease progression, lost to follow-up or death due to any cause, whichever occurs first. | This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point). | Posted | 36 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Transformation to Acute Myeloid Leukemia | This is a measure of transformation to acute myeloid leukemia only for participants who have bone marrow assessments. Transformation to acute myeloid leukemia is defined as the earliest date a participant experiences bone marrow blasts of >=20% after the start of treatment. | This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point). | Posted | 36 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With a Cytogenetic Response | This is a measure of cytogenic response for participants whose best response to therapy is a either a complete or partial cytogenetic response. A complete cytogenetic response is defined as the disappearance of the chromosomal abnormality without appearance of new ones. A partial cytogenetic response is defined as at least 50% reduction of the chromosomal abnormality. | This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point). | Posted | 36 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With a Marrow Remission | This is a measure of bone marrow complete remission for participants who experience a remission. Bone marrow complete remission is defined as a bone marrow assessment of <=5% myeloblasts and decrease by >=50% over pretreatment. | This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point). | Posted | 36 months |
|
|
Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study).
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Thymoglobulin | Thymoglobulin 3.75 mg/kg/day for 5 consecutive days | 7 | 14 | 14 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Serum sickness | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Scleral hyperaemia | Eye disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Local swelling | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Serum sickness | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Central line infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Epstein-Barr virus infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Blood sodium increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Protein urine present | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Benign intracranial hypertension | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Genital ulceration | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Menstrual disorder | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Sexual dysfunction | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Skin chapped | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Stasis dermatitis | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cardiovascular insufficiency | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
The study was terminated early due to a slow enrollment rate; therefore, only safety data were collected from participants for 45 days following the last day of infusion (Day 5).
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Genzyme MedInfo | Genzyme Corporation | 800-745-4447 | medinfo@genzyme.com |
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C512542 | thymoglobulin |
| D000961 | Antilymphocyte Serum |
| ID | Term |
|---|---|
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| Not Reported |
|