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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-002517-12 | EudraCT Number |
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This is a multi-centre, single-arm treatment study combining lenalidomide plus high dose dexamethasone.
Subjects who qualify for participation will receive lenalidomide plus high dose dexamethasone in 4 week cycles. Subjects will be seen every 2 weeks for the first 3 cycles of therapy and then every 4 weeks after the third cycle until disease progression is documented, study drug is discontinued for any reason or lenalidomide becomes commercially available for this indication. Assessments of safety and quality of life are performed during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lenalidomide plus Dexamethasone | Experimental | Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenalidomide | Drug | Oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days. Treatment as tolerated until disease progression, drug became commercially available or limited to 6 treatment cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Incidence of Treatment-emergent Adverse Events (TEAEs), by Severity, Seriousness, and Relationship to Treatment | Counts of study participants who had treatment-emergent adverse events (TEAEs) defined as any reported AE that started on or after the first day of study drug dosing. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) was used by investigators to assess TEAEs. Severity scale ranges from 0 (none) to 5 (death). Grade 3=severe AE; Grade 4=life threatening or disabling AE; Grade 5=death. | up to 123 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Adverse Events of Special Interest: Peripheral Neuropathy | Number of participants with at least one peripheral neuropathy treatment-emergent adverse event (TEAE), and number of participants reporting AEs coded to preferred terms that comprise the search terms for peripheral neuropathy in MedDRA version 9.0 are listed. A participant with multiple occurrences of a TEAE was counted only once for that category. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Knight, MD | Celgene Therapeutic Area Head | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Mater Private Centre for Haematology & Oncology | South Brisbane | QLD 4101 | Australia | |||
| Wilhelminenspital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Yong K, Alegre Amor A, Browne P, Cavenagh J, Dodds T, Greil R, et al. A Multicenter, Single-arm, Open-label Safety and Quality of Life Study of Lenalidomide plus Dexamethasone in previously treated Patients with Multiple Myeloma. Haematologica 2010;95(suppl.2):392, abs. 0944. | ||
| 22292853 | Derived | Alegre A, Oriol-Rocafiguera A, Garcia-Larana J, Mateos MV, Sureda A, Martinez-Chamorro C, Cibeira MT, Aguado B, Knight R, Rosettani B. Efficacy, safety and quality-of-life associated with lenalidomide plus dexamethasone for the treatment of relapsed or refractory multiple myeloma: the Spanish experience. Leuk Lymphoma. 2012 Sep;53(9):1714-21. doi: 10.3109/10428194.2012.662643. Epub 2012 Mar 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lenalidomide Plus Dexamethasone | Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Dexamethasone | Drug | Oral pulse dexamethasone at a dose of 40 mg daily on days 1-4, 9-12, and 17-20 for each 28-day-cycle for cycles 1 through 4. Beginning cycle 5, a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. |
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| up to 124 weeks |
| Time to First Peripheral Neuropathy Treatment-Emergent Adverse Event (TEAE) | Time between first dose and when a TEAE for peripheral neuropathy was reported. The mean is the univariate mean without adjusting for censoring. The treatment duration was used for censored participants. | up to 124 weeks |
| Participants With Adverse Events of Special Interest: Venous Thromboembolic Events | Number of participants with at least one venous thromboembolic treatment-emergent adverse event (TEAE), and number of participants reporting AEs coded to preferred terms that comprise the search terms for venous thromboembolic events in MedDRA version 9.0 are listed. A participant with multiple occurrences of a TEAE was counted only once for that category. | up to 124 weeks |
| Time to First Venous Thromboembolic Treatment-Emergent Adverse Event (TEAE) | Time between first dose and when a TEAE for venous thromboembolic event was reported. The mean is the univariate mean without adjusting for censoring. The treatment duration was used for censored participants. | up to 124 weeks |
| Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale | EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning. | Baseline (Day 0), Week 24 |
| Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale | EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of role functioning. | Baseline (Day 0), Week 24 |
| Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale | EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of emotional functioning. | Baseline (Day 0), Week 24 |
| Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Cognitive Functioning Scale | EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of cognitive functioning. | Baseline (Day 0), Week 24 |
| Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale | EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of social functioning. | Baseline (Day 0), Week 24 |
| Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale | EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the fatigue scale = higher level of symptomatology/problems. | Baseline (Day 0), Week 24 |
| Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale | EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the pain scale = higher level of symptomatology/problems. | Baseline (Day 0), Week 24 |
| Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea/Vomiting Scale | EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the nausea/vomiting scale = higher level of symptomatology/problems. | Baseline (Day 0), Week 24 |
| Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale | EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the constipation scale = higher level of symptomatology/problems. | Baseline (Day 0), Week 24 |
| Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhea Scale | EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the diarrhea scale = higher level of symptomatology/problems. | Baseline (Day 0), Week 24 |
| Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale | EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the insomnia scale = higher level of symptomatology/problems. | Baseline (Day 0), Week 24 |
| Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale | EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the dyspnoea scale = higher level of symptomatology/problems. | Baseline (Day 0), Week 24 |
| Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale | EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the appetite loss scale = higher level of symptomatology/problems. | Baseline (Day 0), Week 24 |
| Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Problems Scale | EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a problem scale like the financial problems scale = higher level of financial problems. | Baseline (Day 0), Week 24 |
| Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale | EORTQ QLC-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better quality of life. | Baseline (Day 0), Week 24 |
| Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the disease symptoms scale = higher level of symptomatology. | Baseline (Day 0), Week 24 |
| Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Scale | EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the side effects scale = higher level of symptomatology. | Baseline (Day 0), Week 24 |
| Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale | EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the future perspective scale, higher score = better perspective of the future. | Baseline (Day 0), Week 24 |
| Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale | EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the body image scale, higher scores = better body image. | Baseline (Day 0), Week 24 |
| Vienna |
| Montlearstrasse 37 |
| 1160 |
| Austria |
| St James's Hospital | Dublin | Ireland |
| H. Clínico de Salamanca | Salamanca | Spain |
| Royal Free Hospital & Medical School | London | NW3 2QG | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lenalidomide Plus Dexamethasone | Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participant |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Incidence of Treatment-emergent Adverse Events (TEAEs), by Severity, Seriousness, and Relationship to Treatment | Counts of study participants who had treatment-emergent adverse events (TEAEs) defined as any reported AE that started on or after the first day of study drug dosing. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) was used by investigators to assess TEAEs. Severity scale ranges from 0 (none) to 5 (death). Grade 3=severe AE; Grade 4=life threatening or disabling AE; Grade 5=death. | Safety population | Posted | Number | participants | up to 123 weeks |
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| Secondary | Participants With Adverse Events of Special Interest: Peripheral Neuropathy | Number of participants with at least one peripheral neuropathy treatment-emergent adverse event (TEAE), and number of participants reporting AEs coded to preferred terms that comprise the search terms for peripheral neuropathy in MedDRA version 9.0 are listed. A participant with multiple occurrences of a TEAE was counted only once for that category. | Safety population | Posted | Number | participants | up to 124 weeks |
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| Secondary | Time to First Peripheral Neuropathy Treatment-Emergent Adverse Event (TEAE) | Time between first dose and when a TEAE for peripheral neuropathy was reported. The mean is the univariate mean without adjusting for censoring. The treatment duration was used for censored participants. | Safety population | Posted | Mean | Standard Deviation | weeks | up to 124 weeks |
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| Secondary | Participants With Adverse Events of Special Interest: Venous Thromboembolic Events | Number of participants with at least one venous thromboembolic treatment-emergent adverse event (TEAE), and number of participants reporting AEs coded to preferred terms that comprise the search terms for venous thromboembolic events in MedDRA version 9.0 are listed. A participant with multiple occurrences of a TEAE was counted only once for that category. | Safety population | Posted | Number | participants | up to 124 weeks |
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| Secondary | Time to First Venous Thromboembolic Treatment-Emergent Adverse Event (TEAE) | Time between first dose and when a TEAE for venous thromboembolic event was reported. The mean is the univariate mean without adjusting for censoring. The treatment duration was used for censored participants. | Safety population | Posted | Mean | Standard Deviation | weeks | up to 124 weeks |
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| Secondary | Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale | EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning. | Full analysis set of participants who completed the questionnaire at baseline and week 24. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Week 24 |
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| Secondary | Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale | EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of role functioning. | Full analysis set of participants who completed the questionnaire at baseline and week 24. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Week 24 |
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| Secondary | Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale | EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of emotional functioning. | Full analysis set of participants who completed the questionnaire at baseline and week 24. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Week 24 |
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| Secondary | Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Cognitive Functioning Scale | EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of cognitive functioning. | Full analysis set of participants who completed the questionnaire at baseline and week 24. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Week 24 |
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| Secondary | Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale | EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of social functioning. | Full analysis set of participants who completed the questionnaire at baseline and week 24. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Week 24 |
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| Secondary | Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale | EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the fatigue scale = higher level of symptomatology/problems. | Full analysis set of participants who completed the questionnaire at baseline and week 24. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Week 24 |
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| Secondary | Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale | EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the pain scale = higher level of symptomatology/problems. | Full analysis set of participants who completed the questionnaire at baseline and week 24. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Week 24 |
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| Secondary | Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea/Vomiting Scale | EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the nausea/vomiting scale = higher level of symptomatology/problems. | Full analysis set of participants who completed the questionnaire at baseline and week 24. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Week 24 |
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| Secondary | Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale | EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the constipation scale = higher level of symptomatology/problems. | Full analysis set of participants who completed the questionnaire at baseline and week 24. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Week 24 |
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| Secondary | Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhea Scale | EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the diarrhea scale = higher level of symptomatology/problems. | Full analysis set of participants who completed the questionnaire at baseline and week 24. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Week 24 |
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| Secondary | Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale | EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the insomnia scale = higher level of symptomatology/problems. | Full analysis set of participants who completed the questionnaire at baseline and week 24. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Week 24 |
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| Secondary | Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale | EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the dyspnoea scale = higher level of symptomatology/problems. | Full analysis set of participants who completed the questionnaire at baseline and week 24. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Week 24 |
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| Secondary | Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale | EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the appetite loss scale = higher level of symptomatology/problems. | Full analysis set of participants who completed the questionnaire at baseline and week 24. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Week 24 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Problems Scale | EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a problem scale like the financial problems scale = higher level of financial problems. | Full analysis set of participants who completed the questionnaire at baseline and week 24. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Week 24 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale | EORTQ QLC-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better quality of life. | Full analysis set of participants who completed the questionnaire at baseline and week 24. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Week 24 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the disease symptoms scale = higher level of symptomatology. | Full analysis set of participants who completed the questionnaire at baseline and week 24. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Week 24 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Scale | EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the side effects scale = higher level of symptomatology. | Full analysis set of participants who completed the questionnaire at baseline and week 24. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Week 24 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale | EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the future perspective scale, higher score = better perspective of the future. | Full analysis set of participants who completed the questionnaire at baseline and week 24. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Week 24 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale | EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the body image scale, higher scores = better body image. | Full analysis set of participants who completed the questionnaire at baseline and week 24. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Week 24 |
|
Up to 123 weeks
A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
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 | Lenalidomide Plus Dexamethasone | Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. | 340 | 587 | 579 | 587 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Lung infection pseudomonal | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Pneumocystis jiroveci pneumonia | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Abscess oral | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Anal infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Brain abscess | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Bronchitis acute | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Bronchitis moraxella | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Cellulitis staphylococcal | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Central line infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Cholecystitis infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Clostridial infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Herpes zoster disseminated | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Joint abscess | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Legionella infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Listeria sepsis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Meningitis streptococcal | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Neutropenic infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Opportunistic infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Parotitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Perianal abscess | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Pilonidal cyst | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Pneumonia legionella | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Pneumonia moraxella | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Pseudomonal bacteraemia | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Subacute endocarditis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Drug interaction | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hyperplasia | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Bronchial hyperactivity | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Systematic Assessment |
| |
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Systematic Assessment |
| |
| Basosquamous carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Systematic Assessment |
| |
| Benign lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Systematic Assessment |
| |
| Gastrointestinal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Systematic Assessment |
| |
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Systematic Assessment |
| |
| Myeloma recurrence | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Arterial thrombosis limb | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Phlebitis superficial | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Atrial thrombosis | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Bladder disorder | Renal and urinary disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Obstructive uropathy | Renal and urinary disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Renal mass | Renal and urinary disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Renal tubular acidosis | Renal and urinary disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Syncope vasovagal | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Cranial nerve paralysis | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Phantom pain | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Serotonin syndrome | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Abdominal strangulated hernia | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Enterovesical fistula | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Oesophageal haemorrhage | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Tetany | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
| |
| Compression fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
| |
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
| |
| Foreign body trauma | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
| |
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
| |
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
| |
| Muscle rupture | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Korsakoff's psychosis alcoholic | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (9.0) | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA (9.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (9.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (9.0) | Systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA (9.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (9.0) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (9.0) | Systematic Assessment |
| |
| Blood culture positive | Investigations | MedDRA (9.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (9.0) | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (9.0) | Systematic Assessment |
| |
| Prostatic specific antigen increased | Investigations | MedDRA (9.0) | Systematic Assessment |
| |
| Steroid withdrawal syndrome | Endocrine disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hyperparathyroidism | Endocrine disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Oedema genital | Reproductive system and breast disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Neuropathy | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (9.0) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
This study was defined primarily as an expanded access program in the selected countries. Treatment was to continue until disease progression, study drug was discontinued for any reason, or lenalidomide became commercially available for indication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director, Clinical Trials Disclosure | Celgene Corporation | 1-888-260-1599 | clinicaltrialdisclosure@celgene.com |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided
| >65 years |
|
| Asian / Pacific Islander |
|
| Black |
|
| Hispanic |
|
| Title | Measurements |
|---|---|
|
| At least one serious AE (SAE) |
|
|
|
|
|
Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland. |
| OG002 | Lenalidomide - Subpopulation From Spain | Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain. |
|
|
| OG002 | Lenalidomide - Subpopulation From Spain | Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain. |
|
|
| OG002 | Lenalidomide - Subpopulation From Spain | Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain. |
|
|
| OG002 | Lenalidomide - Subpopulation From Spain | Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain. |
|
|
| OG002 | Lenalidomide - Subpopulation From Spain | Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain. |
|
|
| OG002 | Lenalidomide - Subpopulation From Spain | Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain. |
|
|
| OG002 | Lenalidomide - Subpopulation From Spain | Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain. |
|
|
| OG002 | Lenalidomide - Subpopulation From Spain | Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain. |
|
|
| OG002 | Lenalidomide - Subpopulation From Spain | Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain. |
|
|
| OG002 | Lenalidomide - Subpopulation From Spain | Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain. |
|
|
| OG002 | Lenalidomide - Subpopulation From Spain | Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain. |
|
|
| OG002 | Lenalidomide - Subpopulation From Spain | Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain. |
|
|
| OG002 | Lenalidomide - Subpopulation From Spain | Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain. |
|
|
| OG002 | Lenalidomide - Subpopulation From Spain | Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain. |
|
|
| OG002 | Lenalidomide - Subpopulation From Spain | Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain. |
|
|
| OG002 | Lenalidomide - Subpopulation From Spain | Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain. |
|
|
| OG002 | Lenalidomide - Subpopulation From Spain | Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain. |
|
|
| OG002 | Lenalidomide - Subpopulation From Spain | Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain. |
|
|
| OG002 | Lenalidomide - Subpopulation From Spain | Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain. |
|
|