TriangleNCT02613182 · OUTCOME
Long-term Safety and Tolerability of NEOD001
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 initiation of study drug through the last study visit or up to 30 days after date of last dose, whichever came first, assessed up to 24 months
What was measured
Adverse events 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 in this outcome
NEOD001 24 mg/kg
NEOD001, 24 mg/kg IV every 28 days for 22 months
| Group | Source count |
|---|---|
| NEOD001 24 mg/kg | 34 |
Reported measurements
Overall number of baseline subjects
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| NEOD001 24 mg/kg | 34 | Not reported | Not reported | Not reported | Not reported |
Serious Adverse Events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| NEOD001 24 mg/kg | 12 | Not reported | Not reported | Not reported | Not reported |
Non-Serious Adverse Events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| NEOD001 24 mg/kg | 34 | Not reported | Not reported | Not reported | Not reported |
Death (all causes)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| NEOD001 24 mg/kg | 6 | Not reported | Not reported | Not reported | Not reported |
Death (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
- 34
- title
- Overall number of baseline subjects
- categories
- measurements
- group Id
- OG000
- value
- 12
- title
- Serious Adverse Events
- categories
- measurements
- group Id
- OG000
- value
- 34
- title
- Non-Serious Adverse Events
- categories
- measurements
- group Id
- OG000
- value
- 6
- title
- Death (all causes)
- categories
- measurements
- group Id
- OG000
- value
- 1
- title
- Death (from Adverse Events)
- denoms
- counts
- group Id
- OG000
- value
- 34
- units
- Participants
- description
- Adverse events 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 28 days for 22 months
- id
- OG000
- title
- NEOD001 24 mg/kg
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- From initiation of study drug through the last study visit or up to 30 days after date of last dose, whichever came first, assessed up to 24 months
- title
- Long-term Safety and Tolerability of NEOD001
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice