TriangleNCT02064387 · OUTCOME
Number of Participants With SAEs and Common (>=5%) Non-serious Adverse Events- Part 2 (MM)
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
- Up to 35 months (maximum duration of follow-up from first dose to last contact or death)
What was measured
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, other medical events according to medical or scientific judgement and all events of possible study treatment-induced liver injury with hyperbilirubinemia. Part 2 MM Population comprised of all Part 2 MM participants who received at least one dose of GSK2857916. SAEs and common (\>=5%) non-SAEs is presented.
Analysis population: Part 2 MM Population
Groups in this outcome
Part 2: GSK2857916 3.40 mg/kg (MM)
Participants with multiple myeloma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle=21 days).
| Group | Source count |
|---|---|
| Part 2: GSK2857916 3.40 mg/kg (MM) | 35 |
Reported measurements
Common non-SAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: GSK2857916 3.40 mg/kg (MM) | 35 | Not reported | Not reported | Not reported | Not reported |
Any SAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: GSK2857916 3.40 mg/kg (MM) | 17 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 35
- title
- Common non-SAE
- categories
- measurements
- group Id
- OG000
- value
- 17
- title
- Any SAE
- denoms
- counts
- group Id
- OG000
- value
- 35
- units
- Participants
- description
- An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, other medical events according to medical or scientific judgement and all events of possible study treatment-induced liver injury with hyperbilirubinemia. Part 2 MM Population comprised of all Part 2 MM participants who received at least one dose of GSK2857916. SAEs and common (\>=5%) non-SAEs is presented.
- groups
- description
- Participants with multiple myeloma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle=21 days).
- id
- OG000
- title
- Part 2: GSK2857916 3.40 mg/kg (MM)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Part 2 MM Population
- reporting Status
- POSTED
- time Frame
- Up to 35 months (maximum duration of follow-up from first dose to last contact or death)
- title
- Number of Participants With SAEs and Common (>=5%) Non-serious Adverse Events- Part 2 (MM)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice