TriangleNCT01348919 · OUTCOME
Number of Participants With Adverse Events (AEs)
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
- From the first administration of CEP-18770 up to approximately 1.5 years
What was measured
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Analysis population: Safety analysis set included all participants who received at least 1 dose of CEP-18770.
Groups in this outcome
CEP-18770 Dose A
Participants received Dose A intravenously (IV) on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
CEP-18770 Dose B
Participants received CEP-18770 Dose B IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
CEP-18770 Dose C
Participants received CEP-18770 Dose C IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
| Group | Source count |
|---|---|
| CEP-18770 Dose A | 3 |
| CEP-18770 Dose B | 5 |
| CEP-18770 Dose C | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CEP-18770 Dose A | 3 | Not reported | Not reported | Not reported | Not reported |
| CEP-18770 Dose B | 5 | Not reported | Not reported | Not reported | Not reported |
| CEP-18770 Dose C | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 3
- units
- Participants
- description
- An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
- groups
- description
- Participants received Dose A intravenously (IV) on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
- id
- OG000
- title
- CEP-18770 Dose A
- description
- Participants received CEP-18770 Dose B IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
- id
- OG001
- title
- CEP-18770 Dose B
- description
- Participants received CEP-18770 Dose C IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
- id
- OG002
- title
- CEP-18770 Dose C
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety analysis set included all participants who received at least 1 dose of CEP-18770.
- reporting Status
- POSTED
- time Frame
- From the first administration of CEP-18770 up to approximately 1.5 years
- title
- Number of Participants With Adverse Events (AEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice