TriangleNCT05546476 · OUTCOME
Part A: Number of Participants With Treatment Emergent Adverse Events (TEAE)
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 dose of study drug until first dose of open-label ponsegromab 400 mg for participants entering Part B or through Week 16 follow-up for participants not entering Part B (including 8 weeks of follow-up from last dose of study drug in part A)
What was measured
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product during the course of a clinical investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not thought to be related to the investigational product. TEAE were defined as any event that was not present before exposure to study drug, or any event already present that worsened in either intensity or frequency after exposure to study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included serious AEs and all non-SAEs.
Analysis population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Groups in this outcome
Part A: Placebo
Part A: Participants were randomized to receive placebo matching to Ponsegromab SC Q4W up to 12 weeks (total of 3 doses).
Part A: Ponsegromab 100 mg
Part A: Participants were randomized to receive Ponsegromab 100 mg SC Q4W up to 12 weeks (total of 3 doses).
Part A: Ponsegromab 200 mg
Part A: Participants were randomized to receive Ponsegromab 200 mg SC Q4W up to 12 weeks (total of 3 doses).
Part A: Ponsegromab 400 mg
Part A: Participants were randomized to receive Ponsegromab 400 mg SC Q4W up to 12 weeks (total of 3 doses).
| Group | Source count |
|---|---|
| Part A: Placebo | 45 |
| Part A: Ponsegromab 100 mg | 46 |
| Part A: Ponsegromab 200 mg | 46 |
| Part A: Ponsegromab 400 mg | 50 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: Placebo | 36 | Not reported | Not reported | Not reported | Not reported |
| Part A: Ponsegromab 100 mg | 32 | Not reported | Not reported | Not reported | Not reported |
| Part A: Ponsegromab 200 mg | 31 | Not reported | Not reported | Not reported | Not reported |
| Part A: Ponsegromab 400 mg | 37 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 36
- group Id
- OG001
- value
- 32
- group Id
- OG002
- value
- 31
- group Id
- OG003
- value
- 37
- denoms
- counts
- group Id
- OG000
- value
- 45
- group Id
- OG001
- value
- 46
- group Id
- OG002
- value
- 46
- group Id
- OG003
- value
- 50
- units
- Participants
- description
- An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product during the course of a clinical investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not thought to be related to the investigational product. TEAE were defined as any event that was not present before exposure to study drug, or any event already present that worsened in either intensity or frequency after exposure to study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included serious AEs and all non-SAEs.
- groups
- description
- Part A: Participants were randomized to receive placebo matching to Ponsegromab SC Q4W up to 12 weeks (total of 3 doses).
- id
- OG000
- title
- Part A: Placebo
- description
- Part A: Participants were randomized to receive Ponsegromab 100 mg SC Q4W up to 12 weeks (total of 3 doses).
- id
- OG001
- title
- Part A: Ponsegromab 100 mg
- description
- Part A: Participants were randomized to receive Ponsegromab 200 mg SC Q4W up to 12 weeks (total of 3 doses).
- id
- OG002
- title
- Part A: Ponsegromab 200 mg
- description
- Part A: Participants were randomized to receive Ponsegromab 400 mg SC Q4W up to 12 weeks (total of 3 doses).
- id
- OG003
- title
- Part A: Ponsegromab 400 mg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
- reporting Status
- POSTED
- time Frame
- From the first dose of study drug until first dose of open-label ponsegromab 400 mg for participants entering Part B or through Week 16 follow-up for participants not entering Part B (including 8 weeks of follow-up from last dose of study drug in part A)
- title
- Part A: Number of Participants With Treatment Emergent Adverse Events (TEAE)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice