TriangleNCT03154047 · OUTCOME
Number of Participants With Adverse Events
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
- Each subject's study participation may have been up to 36 months or until the study was terminated
What was measured
AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome, or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
Analysis population: OLE Safety Population
Groups in this outcome
NEOD001 24 mg/kg
NEOD001, 24 mg/kg IV every 4 weeks
| Group | Source count |
|---|---|
| NEOD001 24 mg/kg | 80 |
Reported measurements
Overall Number Baseline Subjects
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| NEOD001 24 mg/kg | 80 | Not reported | Not reported | Not reported | Not reported |
Serious Adverse Events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| NEOD001 24 mg/kg | 13 | Not reported | Not reported | Not reported | Not reported |
Non-Serious Adverse Events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| NEOD001 24 mg/kg | 57 | Not reported | Not reported | Not reported | Not reported |
Death (all causes)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| NEOD001 24 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
Death Resulting from Adverse Events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| NEOD001 24 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 80
- title
- Overall Number Baseline Subjects
- categories
- measurements
- group Id
- OG000
- value
- 13
- title
- Serious Adverse Events
- categories
- measurements
- group Id
- OG000
- value
- 57
- title
- Non-Serious Adverse Events
- categories
- measurements
- group Id
- OG000
- value
- 1
- title
- Death (all causes)
- categories
- measurements
- group Id
- OG000
- value
- 1
- title
- Death Resulting from Adverse Events
- denoms
- counts
- group Id
- OG000
- value
- 80
- units
- Participants
- description
- AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome, or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
- groups
- description
- NEOD001, 24 mg/kg IV every 4 weeks
- id
- OG000
- title
- NEOD001 24 mg/kg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- OLE Safety Population
- reporting Status
- POSTED
- time Frame
- Each subject's study participation may have been up to 36 months or until the study was terminated
- title
- Number of Participants With Adverse Events
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice