NCT04068896 · OUTCOME
To Determine the Safety and Tolerability of NGM120 in Subjects
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 enrollment to end of treatment up to 24 months
What was measured
Number of Participants with NGM120/Placebo-Related Treatment Emergent Adverse Events
Analysis population: Safety analysis set
Groups in this outcome
Part 1 NGM120 30mg
NGM120 30mg Subcutaneous Injection
Part 1 NGM120 100mg
NGM120 100mg Subcutaneous Injection
Part 2 NGM120 30mg
NGM120 30mg Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
Part 2 NGM120 100mg
NGM120 100mg Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
Part 2 Placebo
Placebo Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
Part 3 NGM120 100mg
NGM120 100mg Subcutaneous Injection
| Group | Source count |
|---|---|
| Part 1 NGM120 30mg | 10 |
| Part 1 NGM120 100mg | 10 |
| Part 2 NGM120 30mg | 10 |
| Part 2 NGM120 100mg | 31 |
| Part 2 Placebo | 20 |
| Part 3 NGM120 100mg | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 NGM120 30mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1 NGM120 100mg | 6 | Not reported | Not reported | Not reported | Not reported |
| Part 2 NGM120 30mg | 6 | Not reported | Not reported | Not reported | Not reported |
| Part 2 NGM120 100mg | 17 | Not reported | Not reported | Not reported | Not reported |
| Part 2 Placebo | 12 | Not reported | Not reported | Not reported | Not reported |
| Part 3 NGM120 100mg | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 17
- group Id
- OG004
- value
- 12
- group Id
- OG005
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 31
- group Id
- OG004
- value
- 20
- group Id
- OG005
- value
- 6
- units
- Participants
- description
- Number of Participants with NGM120/Placebo-Related Treatment Emergent Adverse Events
- groups
- description
- NGM120 30mg Subcutaneous Injection
- id
- OG000
- title
- Part 1 NGM120 30mg
- description
- NGM120 100mg Subcutaneous Injection
- id
- OG001
- title
- Part 1 NGM120 100mg
- description
- NGM120 30mg Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
- id
- OG002
- title
- Part 2 NGM120 30mg
- description
- NGM120 100mg Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
- id
- OG003
- title
- Part 2 NGM120 100mg
- description
- Placebo Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
- id
- OG004
- title
- Part 2 Placebo
- description
- NGM120 100mg Subcutaneous Injection
- id
- OG005
- title
- Part 3 NGM120 100mg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety analysis set
- reporting Status
- POSTED
- time Frame
- From enrollment to end of treatment up to 24 months
- title
- To Determine the Safety and Tolerability of NGM120 in Subjects
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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