NCT01607892 · 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 first dose of study drug administration to end of treatment (up to 27 months)
- Other-event reporting threshold
- 5%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Diffuse Large B-cell Lymphoma (DLBCL) | 33 / 58 | 58 / 58 | Not reported / Not reported |
| Non-Hodgkin Lymphoma (NHL) Excluding DLBCL | 7 / 27 | 27 / 27 | Not reported / Not reported |
| Multiple Myeloma (MM) | 52 / 81 | 80 / 81 | Not reported / Not reported |
| Acute Myeloid Leukemia (AML) | 73 / 95 | 94 / 95 | Not reported / Not reported |
| Other Hematological Malignancies (ALL, CML and CLL) | 13 / 24 | 24 / 24 | Not reported / Not reported |
Serious adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 24
- term
- Embolism
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 24
- term
- Hypotension
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Surgical and medical procedures
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 24
- term
- Small intestinal resection
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 4
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 24
- term
- Malignant neoplasm progression
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 24
- term
- Tumour pain
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 5
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 24
- term
- Pyrexia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 6
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 24
- term
- Fatigue
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 3
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 24
- term
- Death
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 24
- term
- Asthenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 24
- term
- Disease progression
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 24
- term
- Multiple organ dysfunction syndrome
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 24
- term
- Gait disturbance
Other reported adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 9
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 19
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 2
- num At Risk
- 24
- term
- Hypotension
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 9
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 3
- num At Risk
- 24
- term
- Hypertension
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 5
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 24
- term
- Orthostatic hypotension
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 24
- term
- Hot flush
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 39
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 13
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 62
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 67
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 16
- num At Risk
- 24
- term
- Fatigue
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 21
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 22
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 20
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 24
- term
- Pyrexia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 13
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 8
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 21
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 2
- num At Risk
- 24
- term
- Oedema peripheral
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 14
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 7
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 24
- term
- Asthenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 7
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 7
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 2
- num At Risk
- 24
- term
- Chills
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 7
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 2
- num At Risk
- 24
- term
- Gait disturbance
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 5
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 24
- term
- Malaise
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 8
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 4
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 24
- term
- Non-cardiac chest pain
Complete source fields
- event Groups
- description
- Participants with DLBCL received Selinexor in different Schedules; Schedule 1: \<= 12 milligram per square meter (mg/m\^2) per orally (PO) alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: \> 12 mg/m\^2 PO 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \>=30 mg/m\^2 PO twice weekly (1 day between doses); Schedule 4: \>=23 mg/m\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \>=30 mg/m\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 8: \>=40 mg/m\^2 PO twice weekly (1 day between doses) during Weeks 1 and 2; Schedule 9: \>=45 mg/m\^2 PO twice weekly in combination with 375 mg/m\^2 dose of rituximab intravenous (IV) once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.
- id
- EG000
- other Num Affected
- 58
- other Num At Risk
- 58
- serious Num Affected
- 33
- serious Num At Risk
- 58
- title
- Diffuse Large B-cell Lymphoma (DLBCL)
- description
- Participants with NHL received Selinexor in different Schedules; Schedule 1: \<= 12 mg/m\^2 PO alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: \> 12 mg/m\^2 PO 3 times weekly for week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \>=30 mg/m\^2 PO twice weekly (1 day between doses); Schedule 5: \>=30 mg/m\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs 1 day apart (Schedule 3); Schedule 7: \>=45 mg/m\^2 PO once weekly (6 days between doses) to evaluate vs twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: \>=40 mg/m\^2 PO twice weekly \[1 Day between doses\] during weeks 1 and 2; Schedule 9: \>=45 mg/m\^2 PO twice weekly in combination with 375 mg/m\^2 dose of rituximab IV once weekly for Weeks 1-4) during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.
- id
- EG001
- other Num Affected
- 27
- other Num At Risk
- 27
- serious Num Affected
- 7
- serious Num At Risk
- 27
- title
- Non-Hodgkin Lymphoma (NHL) Excluding DLBCL
- description
- Participants with MM received Selinexor in different Schedules; Schedule 1: \<= 12 mg/m\^2 PO alternating 3 times per week with twice weekly dosing (1 Day between doses); Schedule 2: \> 12 mg/m\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; 3 doses (36 mg/m\^2 total) in the 1-week run-in period; Schedule 3: \>=30 mg/m\^2 PO twice weekly (1 day between doses); Schedule 4: \>=23 mg/m\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \>=30 mg/m\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 6: \>= 35 mg/m\^2 PO twice weekly with dexamethasone (20 mg twice weekly) on Days of twice weekly Selinexor dosing; Schedule 11: Group A: 40 mg; Group B: 60 mg; Group C: 80 mg twice weekly (Weeks 1, 2, and 3) at 3 fixed dose levels during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.
- id
- EG002
- other Num Affected
- 80
- other Num At Risk
- 81
- serious Num Affected
- 52
- serious Num At Risk
- 81
- title
- Multiple Myeloma (MM)
- description
- Participants with AML received Selinexor in different Schedules; Schedule 2: \> 12 mg/m\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \>=30 mg/m\^2 PO twice weekly (1 day between doses); Schedule 5: \>=30 mg/m\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3), Schedule 7: \>=45 mg/m\^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: \>=40 mg/m\^2 PO twice weekly (1 Day between doses) during Weeks 1 and 2; Schedule 10: \>= 55 mg/m\^2 PO twice weekly PO (Weeks 1 and 2) in participants with AML/18-Day treatment-free interval) during different cycles. Each cycle was of 28 days (for schedule 8: 21-day of cycle) or 10 scheduled selinexor doses.
- id
- EG003
- other Num Affected
- 94
- other Num At Risk
- 95
- serious Num Affected
- 73
- serious Num At Risk
- 95
- title
- Acute Myeloid Leukemia (AML)
- description
- Participants with other hematological malignancies (Acute lymphoblastic leukemia \[ALL\], Chronic myelogenous leukemia \[CML\] and chronic lymphocytic leukemia \[CLL\]) received Schedule 2: \> 12 mg/m\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \>=30 mg/m\^2 PO twice weekly \[1 day between doses\]; Schedule 4: \>=23 mg/m\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \>=30 mg/m\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 7: \>=45 mg/m\^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 9: \>=45 mg/m\^2 PO twice weekly in combination with 375 mg/m\^2 dose of rituximab IV once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.
- id
- EG004
- other Num Affected
- 24
- other Num At Risk
- 24
- serious Num Affected
- 13
- serious Num At Risk
- 24
- title
- Other Hematological Malignancies (ALL, CML and CLL)
- frequency Threshold
- 5
- other Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 9
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 19
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 2
- num At Risk
- 24
- term
- Hypotension
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 9
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 3
- num At Risk
- 24
- term
- Hypertension
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 5
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 24
- term
- Orthostatic hypotension
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 24
- term
- Hot flush
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 39
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 13
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 62
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 67
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 16
- num At Risk
- 24
- term
- Fatigue
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 21
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 22
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 20
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 24
- term
- Pyrexia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 13
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 8
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 21
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 2
- num At Risk
- 24
- term
- Oedema peripheral
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 14
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 7
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 24
- term
- Asthenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 7
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 7
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 2
- num At Risk
- 24
- term
- Chills
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 7
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 2
- num At Risk
- 24
- term
- Gait disturbance
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 5
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 24
- term
- Malaise
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 8
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 4
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 24
- term
- Non-cardiac chest pain
- serious Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 24
- term
- Embolism
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 24
- term
- Hypotension
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Surgical and medical procedures
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 24
- term
- Small intestinal resection
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 4
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 24
- term
- Malignant neoplasm progression
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 24
- term
- Tumour pain
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 5
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 24
- term
- Pyrexia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 6
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 24
- term
- Fatigue
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 3
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 24
- term
- Death
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 24
- term
- Asthenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 24
- term
- Disease progression
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 24
- term
- Multiple organ dysfunction syndrome
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA (17.1)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 58
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 27
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 81
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 95
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 24
- term
- Gait disturbance
- time Frame
- From first dose of study drug administration to end of treatment (up to 27 months)
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Preserved source evidence · Not medical advice
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