TriangleNCT01338987 · OUTCOME
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Date treatment consent signed to date off study, approximately 79 months and 11 days.
What was measured
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Analysis population: 40/45 transplant recipients and all 31 donors were evaluable for adverse events as five patients did not proceed to transplant after enrollment due to progression of disease in four cases and enrollment on a new protocol in one case.
Groups in this outcome
Males That Did Not Receive Leuprolide for 1st Transplant
Males undergoing first transplant who did not receive leuprolide.
Males Randomized to Receive Leuprolide for 1st Transplant
Males undergoing first transplant who were randomized to receive leuprolide.
Females That Received Leuprolide for 1st Transplant
Females undergoing first transplant who all received leuprolide.
Matched Related Donors for Transplant
Individuals related to patients and who gave hematopoietic stem cells for patients receiving allogeneic Bone Marrow Transplant on this study.
Recipients of 2nd Transplant
Patients receiving second allogeneic Bone Marrow Transplant on this study.
| Group | Source count |
|---|---|
| Males That Did Not Receive Leuprolide for 1st Transplant | 10 |
| Males Randomized to Receive Leuprolide for 1st Transplant | 8 |
| Females That Received Leuprolide for 1st Transplant | 20 |
| Matched Related Donors for Transplant | 31 |
| Recipients of 2nd Transplant | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Males That Did Not Receive Leuprolide for 1st Transplant | 10 | Not reported | Not reported | Not reported | Not reported |
| Males Randomized to Receive Leuprolide for 1st Transplant | 8 | Not reported | Not reported | Not reported | Not reported |
| Females That Received Leuprolide for 1st Transplant | 20 | Not reported | Not reported | Not reported | Not reported |
| Matched Related Donors for Transplant | 4 | Not reported | Not reported | Not reported | Not reported |
| Recipients of 2nd Transplant | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 20
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 20
- group Id
- OG003
- value
- 31
- group Id
- OG004
- value
- 2
- units
- Participants
- description
- Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
- groups
- description
- Males undergoing first transplant who did not receive leuprolide.
- id
- OG000
- title
- Males That Did Not Receive Leuprolide for 1st Transplant
- description
- Males undergoing first transplant who were randomized to receive leuprolide.
- id
- OG001
- title
- Males Randomized to Receive Leuprolide for 1st Transplant
- description
- Females undergoing first transplant who all received leuprolide.
- id
- OG002
- title
- Females That Received Leuprolide for 1st Transplant
- description
- Individuals related to patients and who gave hematopoietic stem cells for patients receiving allogeneic Bone Marrow Transplant on this study.
- id
- OG003
- title
- Matched Related Donors for Transplant
- description
- Patients receiving second allogeneic Bone Marrow Transplant on this study.
- id
- OG004
- title
- Recipients of 2nd Transplant
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- 40/45 transplant recipients and all 31 donors were evaluable for adverse events as five patients did not proceed to transplant after enrollment due to progression of disease in four cases and enrollment on a new protocol in one case.
- reporting Status
- POSTED
- time Frame
- Date treatment consent signed to date off study, approximately 79 months and 11 days.
- title
- Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice