NCT00322387 · 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
- Treatment Period includes the first day of G-CSF mobilization to the day prior to chemotherapy/ablative treatment in preparation for the first transplant. This period includes G-CSF administration, the plerixafor dose, and the rest period.
- Other-event reporting threshold
- 0%
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes events, regardless of reported relationship to study treatment or grade.
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Non-Hodgkin's Lymphoma (NHL): Plerixafor PM | 1 / 7 | 7 / 7 | Not reported / Not reported |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor AM | 0 / 6 | 6 / 6 | Not reported / Not reported |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo | 0 / 1 | 1 / 1 | Not reported / Not reported |
| Multiple Myeloma (MM): Plerixafor PM | 2 / 12 | 12 / 12 | Not reported / Not reported |
| Multiple Myeloma (MM): Plerixafor AM | 2 / 9 | 9 / 9 | Not reported / Not reported |
| Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM | 0 / 1 | 1 / 1 | Not reported / Not reported |
| Multiple Myeloma (MM): Plerixafor After Chemo | 1 / 4 | 2 / 4 | Not reported / Not reported |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- Five participants experienced neutropenia starting before the first dose of plerixafor.
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 7
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 12
- group Id
- EG004
- num Affected
- 2
- num At Risk
- 9
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 4
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 12
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 4
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 12
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 4
- term
- Vomiting
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- One participant experienced stapylococcal sepsis immediately after salvage chemotherapy 24 days after the participant received plerixafor.
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 7
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 4
- term
- Staphylococcal sepsis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Renal and urinary disorders
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 12
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 4
- term
- Cystitis haemorrhagic
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 7
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 4
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 9
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 4
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 7
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 12
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 4
- term
- Tachycardia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 7
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 4
- term
- Tinnitus
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 12
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 4
- term
- Eyelid oedema
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 1
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 4
- term
- Vision blurred
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 7
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 9
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 4
- term
- Abdominal distension
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 12
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 4
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 9
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 4
- term
- Abdominal pain lower
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 7
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 4
- term
- Abdominal pain upper
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 4
- term
- Anal fistula
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 7
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG003
- num Affected
- 6
- num At Risk
- 12
- group Id
- EG004
- num Affected
- 3
- num At Risk
- 9
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 1
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 4
- term
- Diarrhoea
Complete source fields
- description
- In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes events, regardless of reported relationship to study treatment or grade.
- event Groups
- description
- Participants with NHL who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
- id
- EG000
- other Num Affected
- 7
- other Num At Risk
- 7
- serious Num Affected
- 1
- serious Num At Risk
- 7
- title
- Non-Hodgkin's Lymphoma (NHL): Plerixafor PM
- description
- Participants with NHL who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
- id
- EG001
- other Num Affected
- 6
- other Num At Risk
- 6
- serious Num Affected
- 0
- serious Num At Risk
- 6
- title
- Non-Hodgkin's Lymphoma (NHL): Plerixafor AM
- description
- Participants with NHL who followed the Plerixafor After Chemo treatment arm regimen. Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached \>= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms.
- id
- EG002
- other Num Affected
- 1
- other Num At Risk
- 1
- serious Num Affected
- 0
- serious Num At Risk
- 1
- title
- Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo
- description
- Participants with MM who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
- id
- EG003
- other Num Affected
- 12
- other Num At Risk
- 12
- serious Num Affected
- 2
- serious Num At Risk
- 12
- title
- Multiple Myeloma (MM): Plerixafor PM
- description
- Participants with MM who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
- id
- EG004
- other Num Affected
- 9
- other Num At Risk
- 9
- serious Num Affected
- 2
- serious Num At Risk
- 9
- title
- Multiple Myeloma (MM): Plerixafor AM
- description
- Participants with MM who followed the Low CD34+ Count/Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of \>=10 cells/µL but \<20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was adminstered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days.
- id
- EG005
- other Num Affected
- 1
- other Num At Risk
- 1
- serious Num Affected
- 0
- serious Num At Risk
- 1
- title
- Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM
- description
- Participants with MM who followed the Plerixafor After Chemo treatment arm regimen. Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached \>= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms.
- id
- EG006
- other Num Affected
- 2
- other Num At Risk
- 4
- serious Num Affected
- 1
- serious Num At Risk
- 4
- title
- Multiple Myeloma (MM): Plerixafor After Chemo
- frequency Threshold
- 0
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 7
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 4
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 9
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 4
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 7
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 12
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 4
- term
- Tachycardia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 7
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 4
- term
- Tinnitus
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 12
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 4
- term
- Eyelid oedema
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 1
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 4
- term
- Vision blurred
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 7
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 9
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 4
- term
- Abdominal distension
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 12
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 4
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 9
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 4
- term
- Abdominal pain lower
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 7
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 4
- term
- Abdominal pain upper
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 4
- term
- Anal fistula
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 7
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG003
- num Affected
- 6
- num At Risk
- 12
- group Id
- EG004
- num Affected
- 3
- num At Risk
- 9
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 1
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 4
- term
- Diarrhoea
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- Five participants experienced neutropenia starting before the first dose of plerixafor.
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 7
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 12
- group Id
- EG004
- num Affected
- 2
- num At Risk
- 9
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 4
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 12
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 4
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 12
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 4
- term
- Vomiting
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- One participant experienced stapylococcal sepsis immediately after salvage chemotherapy 24 days after the participant received plerixafor.
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 7
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 4
- term
- Staphylococcal sepsis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Renal and urinary disorders
- source Vocabulary
- MedDRA 10.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 12
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 1
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 4
- term
- Cystitis haemorrhagic
- time Frame
- Treatment Period includes the first day of G-CSF mobilization to the day prior to chemotherapy/ablative treatment in preparation for the first transplant. This period includes G-CSF administration, the plerixafor dose, and the rest period.
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle