TriangleNCT01338987 · OUTCOME
Number of Adverse Events Related to Study Drug Experienced by Participants After Second Bone Marrow Transplant (BMT)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Adverse Events
- Interval / dispersion
- Not reported
- Time frame
- 12 months after second BMT
What was measured
Serious and non-serious adverse events were 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: Only the patients in the SG4 group who had a 2nd BMT had a primary endpoint of toxicity requiring leuprolide AE reporting.
Groups in this outcome
Transplant Recipient - 2nd Bone Marrow Transplant
Patients receiving second allogeneic bone marrow transplant on this study.
| Group | Source count |
|---|---|
| Transplant Recipient - 2nd Bone Marrow Transplant | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Transplant Recipient - 2nd Bone Marrow Transplant | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 2
- units
- Participants
- description
- Serious and non-serious adverse events were 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
- Patients receiving second allogeneic bone marrow transplant on this study.
- id
- OG000
- title
- Transplant Recipient - 2nd Bone Marrow Transplant
- param Type
- NUMBER
- population Description
- Only the patients in the SG4 group who had a 2nd BMT had a primary endpoint of toxicity requiring leuprolide AE reporting.
- reporting Status
- POSTED
- time Frame
- 12 months after second BMT
- title
- Number of Adverse Events Related to Study Drug Experienced by Participants After Second Bone Marrow Transplant (BMT)
- type
- PRIMARY
- unit Of Measure
- Adverse Events
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice