NCT00689936 · ADVERSE EVENTS
Adverse events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.
- Collection time frame
- From the first dose of treatment to at least 28 days after discontinuation of active treatment for those not continuing in the PFS phase; median duration of treatment was 80.2 weeks in the Rd arm, 72.0 weeks in the Rd18 arm and 67.1 weeks in the MPT arm.
- Other-event reporting threshold
- 5%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | 378 / 532 | 523 / 532 | Not reported / Not reported |
| Lenalidomide and Dexamethasone (Rd18) | 308 / 540 | 532 / 540 | Not reported / Not reported |
| Melphalan + Prednisone + Thalidomide (MPT) | 270 / 541 | 532 / 541 | Not reported / Not reported |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 24
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 15
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 23
- num At Risk
- 541
- term
- ANAEMIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 541
- term
- ANAEMIA HAEMOLYTIC AUTOIMMUNE
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 541
- term
- DISSEMINATED INTRAVASCULAR COAGULATION
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 541
- term
- FEBRILE BONE MARROW APLASIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 8
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 13
- num At Risk
- 541
- term
- FEBRILE NEUTROPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 541
- term
- HAEMOLYSIS
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 541
- term
- HYPERVISCOSITY SYNDROME
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 541
- term
- HYPOCOAGULABLE STATE
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 541
- term
- IDIOPATHIC THROMBOCYTOPENIC PURPURA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 541
- term
- LEUKOPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 541
- term
- LYMPHADENITIS
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 541
- term
- LYMPHOPENIA
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 237
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 191
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 219
- num At Risk
- 541
- term
- ANAEMIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 66
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 59
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 92
- num At Risk
- 541
- term
- LEUKOPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 60
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 43
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 71
- num At Risk
- 541
- term
- LYMPHOPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 194
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 177
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 325
- num At Risk
- 541
- term
- NEUTROPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 111
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 99
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 132
- num At Risk
- 541
- term
- THROMBOCYTOPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 30
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 541
- term
- ATRIAL FIBRILLATION
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 27
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 35
- num At Risk
- 541
- term
- VERTIGO
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 84
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 31
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 541
- term
- CATARACT
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 30
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 541
- term
- VISION BLURRED
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 68
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 40
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 28
- num At Risk
- 541
- term
- ABDOMINAL PAIN
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 50
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 34
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 29
- num At Risk
- 541
- term
- ABDOMINAL PAIN UPPER
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 233
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 210
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 282
- num At Risk
- 541
- term
- CONSTIPATION
Complete source fields
- event Groups
- description
- Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants \> 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
- id
- EG000
- other Num Affected
- 523
- other Num At Risk
- 532
- serious Num Affected
- 378
- serious Num At Risk
- 532
- title
- Lenalidomide and Low-Dose Dexamethasone (Rd)
- description
- Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those \> 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
- id
- EG001
- other Num Affected
- 532
- other Num At Risk
- 540
- serious Num Affected
- 308
- serious Num At Risk
- 540
- title
- Lenalidomide and Dexamethasone (Rd18)
- description
- Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
- id
- EG002
- other Num Affected
- 532
- other Num At Risk
- 541
- serious Num Affected
- 270
- serious Num At Risk
- 541
- title
- Melphalan + Prednisone + Thalidomide (MPT)
- frequency Threshold
- 5
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 237
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 191
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 219
- num At Risk
- 541
- term
- ANAEMIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 66
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 59
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 92
- num At Risk
- 541
- term
- LEUKOPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 60
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 43
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 71
- num At Risk
- 541
- term
- LYMPHOPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 194
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 177
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 325
- num At Risk
- 541
- term
- NEUTROPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 111
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 99
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 132
- num At Risk
- 541
- term
- THROMBOCYTOPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 30
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 541
- term
- ATRIAL FIBRILLATION
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 27
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 35
- num At Risk
- 541
- term
- VERTIGO
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 84
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 31
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 541
- term
- CATARACT
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 30
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 541
- term
- VISION BLURRED
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 68
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 40
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 28
- num At Risk
- 541
- term
- ABDOMINAL PAIN
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 50
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 34
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 29
- num At Risk
- 541
- term
- ABDOMINAL PAIN UPPER
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 233
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 210
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 282
- num At Risk
- 541
- term
- CONSTIPATION
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 24
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 15
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 23
- num At Risk
- 541
- term
- ANAEMIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 541
- term
- ANAEMIA HAEMOLYTIC AUTOIMMUNE
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 541
- term
- DISSEMINATED INTRAVASCULAR COAGULATION
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 541
- term
- FEBRILE BONE MARROW APLASIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 8
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 13
- num At Risk
- 541
- term
- FEBRILE NEUTROPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 541
- term
- HAEMOLYSIS
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 541
- term
- HYPERVISCOSITY SYNDROME
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 541
- term
- HYPOCOAGULABLE STATE
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 541
- term
- IDIOPATHIC THROMBOCYTOPENIC PURPURA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 541
- term
- LEUKOPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 541
- term
- LYMPHADENITIS
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MEDDRA15.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 532
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 540
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 541
- term
- LYMPHOPENIA
- time Frame
- From the first dose of treatment to at least 28 days after discontinuation of active treatment for those not continuing in the PFS phase; median duration of treatment was 80.2 weeks in the Rd arm, 72.0 weeks in the Rd18 arm and 67.1 weeks in the MPT arm.
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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