NCT03525678 · OUTCOME
Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI)
A Study to Investigate the Efficacy and Safety of Two Doses of GSK2857916 in Participants With Multiple Myeloma Who Have Failed Prior Treatment With an Anti-CD38 Antibody · Source last updated 2025-09-03
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 186 weeks
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; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. Adverse events which were not Serious were considered as non-serious adverse events. Number of participants who had SAEs and common (\>=5%) non-SAEs are presented. Number of participants with AESI (keratopathy, dry eye events, blurred vision, thrombocytopenia, infusion-related reactions, corneal events and neutropenia) are also presented.
Analysis population: Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.
Groups in this outcome
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 95 |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 99 |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 24 |
|---|
Reported measurements
Common non-SAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 93 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 96 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 24 | Not reported | Not reported | Not reported | Not reported |
|---|
SAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 43 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 53 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
Keratopathy
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 67 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 74 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 23 | Not reported | Not reported | Not reported | Not reported |
|---|
Dry eye events
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 17 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 25 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Blurred vision
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 24 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 36 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
Thrombocytopenia
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 36 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 56 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
Infusion-related reactions
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 20 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 16 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Corneal events
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 68 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 76 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 23 | Not reported | Not reported | Not reported | Not reported |
|---|
Neutropenia
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 28 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 93
- group Id
- OG001
- value
- 96
- group Id
- OG002
- value
- 24
- title
- Common non-SAE
- categories
- measurements
- group Id
- OG000
- value
- 43
- group Id
- OG001
- value
- 53
- group Id
- OG002
- value
- 15
- title
- SAE
- categories
- measurements
- group Id
- OG000
- value
- 67
- group Id
- OG001
- value
- 74
- group Id
- OG002
- value
- 23
- title
- Keratopathy
- categories
- measurements
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 25
- group Id
- OG002
- value
- 6
- title
- Dry eye events
- categories
- measurements
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 36
- group Id
- OG002
- value
- 10
- title
- Blurred vision
- categories
- measurements
- group Id
- OG000
- value
- 36
- group Id
- OG001
- value
- 56
- group Id
- OG002
- value
- 10
- title
- Thrombocytopenia
- categories
- measurements
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 4
- title
- Infusion-related reactions
- categories
- measurements
- group Id
- OG000
- value
- 68
- group Id
- OG001
- value
- 76
- group Id
- OG002
- value
- 23
- title
- Corneal events
- categories
- measurements
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 28
- group Id
- OG002
- value
- 2
- title
- Neutropenia
- denoms
- counts
- group Id
- OG000
- value
- 95
- group Id
- OG001
- value
- 99
- group Id
- OG002
- value
- 24
- 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; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. Adverse events which were not Serious were considered as non-serious adverse events. Number of participants who had SAEs and common (\>=5%) non-SAEs are presented. Number of participants with AESI (keratopathy, dry eye events, blurred vision, thrombocytopenia, infusion-related reactions, corneal events and neutropenia) are also presented.
- groups
- description
- Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
- id
- OG000
- title
- Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)
- description
- Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
- id
- OG001
- title
- Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)
- description
- Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
- id
- OG002
- title
- Main Study: GSK2857916 3.4 mg/kg (Lyophilized)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.
- reporting Status
- POSTED
- time Frame
- Up to 186 weeks
- title
- Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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