NCT04442126 · OUTCOME
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- From baseline to up to 12 weeks post last dose, up to 48 weeks.
What was measured
Frequency and severity of adverse events
Analysis population: Participant with any TREA
Groups in this outcome
Part A Dose Level 1 NM21-1490-Q2W 0.15mg
Part A Dose Level 1 NM21-1490-Q2W 0.15mg
Part A Dose Level 2 NM21-1490-Q2W 1.5mg
Part A Dose Level 2 NM21-1490-Q2W 1.5mg
Part A Dose Level 3 NM21-1490-Q2W 8mg
Part A Dose Level 3 NM21-1490-Q2W 8mg
Part A Dose Level 4 NM21-1490-Q2W 24mg
Part A Dose Level 4 NM21-1490-Q2W 24mg
Part A Dose Level 5 NM21-1490-Q2W 80mg
Part A Dose Level 5 NM21-1490-Q2W 80mg
Part A Dose Level 6 NM21-1490-Q2W 240mg
Part A Dose Level 6 NM21-1490-Q2W 240mg
Part A Dose Level 7 NM21-1490-Q2W 800mg
Part A Dose Level 7 NM21-1490-Q2W 800mg
Part A2 NM32-1480-Q2W
Part A2 NM32-1480-Q2W 1400mg
Part B NM32-1480-Q2W
Part B NM32-1480-Q2W 800mg
| Group | Source count |
|---|---|
| Part A Dose Level 1 NM21-1490-Q2W 0.15mg | 1 |
| Part A Dose Level 2 NM21-1490-Q2W 1.5mg | 1 |
| Part A Dose Level 3 NM21-1490-Q2W 8mg | 3 |
| Part A Dose Level 4 NM21-1490-Q2W 24mg | 3 |
| Part A Dose Level 5 NM21-1490-Q2W 80mg | 6 |
| Part A Dose Level 6 NM21-1490-Q2W 240mg | 3 |
| Part A Dose Level 7 NM21-1490-Q2W 800mg | 9 |
| Part A2 NM32-1480-Q2W | 5 |
| Part B NM32-1480-Q2W | 21 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A Dose Level 1 NM21-1490-Q2W 0.15mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part A Dose Level 2 NM21-1490-Q2W 1.5mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part A Dose Level 3 NM21-1490-Q2W 8mg | 3 | Not reported | Not reported | Not reported | Not reported |
| Part A Dose Level 4 NM21-1490-Q2W 24mg | 3 | Not reported | Not reported | Not reported | Not reported |
| Part A Dose Level 5 NM21-1490-Q2W 80mg | 5 | Not reported | Not reported | Not reported | Not reported |
| Part A Dose Level 6 NM21-1490-Q2W 240mg | 3 | Not reported | Not reported | Not reported | Not reported |
| Part A Dose Level 7 NM21-1490-Q2W 800mg | 9 | Not reported | Not reported | Not reported | Not reported |
| Part A2 NM32-1480-Q2W | 5 | Not reported | Not reported | Not reported | Not reported |
| Part B NM32-1480-Q2W | 16 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 9
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 16
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 9
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 21
- units
- Participants
- description
- Frequency and severity of adverse events
- groups
- description
- Part A Dose Level 1 NM21-1490-Q2W 0.15mg
- id
- OG000
- title
- Part A Dose Level 1 NM21-1490-Q2W 0.15mg
- description
- Part A Dose Level 2 NM21-1490-Q2W 1.5mg
- id
- OG001
- title
- Part A Dose Level 2 NM21-1490-Q2W 1.5mg
- description
- Part A Dose Level 3 NM21-1490-Q2W 8mg
- id
- OG002
- title
- Part A Dose Level 3 NM21-1490-Q2W 8mg
- description
- Part A Dose Level 4 NM21-1490-Q2W 24mg
- id
- OG003
- title
- Part A Dose Level 4 NM21-1490-Q2W 24mg
- description
- Part A Dose Level 5 NM21-1490-Q2W 80mg
- id
- OG004
- title
- Part A Dose Level 5 NM21-1490-Q2W 80mg
- description
- Part A Dose Level 6 NM21-1490-Q2W 240mg
- id
- OG005
- title
- Part A Dose Level 6 NM21-1490-Q2W 240mg
- description
- Part A Dose Level 7 NM21-1490-Q2W 800mg
- id
- OG006
- title
- Part A Dose Level 7 NM21-1490-Q2W 800mg
- description
- Part A2 NM32-1480-Q2W 1400mg
- id
- OG007
- title
- Part A2 NM32-1480-Q2W
- description
- Part B NM32-1480-Q2W 800mg
- id
- OG008
- title
- Part B NM32-1480-Q2W
- param Type
- NUMBER
- population Description
- Participant with any TREA
- reporting Status
- POSTED
- time Frame
- From baseline to up to 12 weeks post last dose, up to 48 weeks.
- title
- Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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