NCT05259696 · OUTCOME
Number of Participants Who Experienced AEs or SAEs
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
- 15 Months
What was measured
Number of participants who experienced an adverse events (AEs) or a serious adverse event (SAE)
Groups in this outcome
E-602 1 mg/kg
Participants received 1 mg/kg E-602 monotherapy administered weekly via IV infusion.
E-602 3 mg/kg
Participants received 3 mg/kg E-602 monotherapy administered weekly via IV infusion.
E-602 10 mg/kg
Participants received 10 mg/kg E-602 monotherapy administered weekly via IV infusion.
E-602 20 mg/kg
Participants received 20 mg/kg E-602 monotherapy administered weekly via IV infusion.
E-602 30 mg/kg
Participants received 30 mg/kg E-602 monotherapy administered weekly via IV infusion.
E-602 20 mg/kg in Combination With Cemiplimab
Participants received 20 mg/kg E-602 monotherapy administered weekly via IV infusion. They also received 350 mg cemiplimab administered every 3 weeks via IV infusion.
| Group | Source count |
|---|---|
| E-602 1 mg/kg | 5 |
| E-602 3 mg/kg | 4 |
| E-602 10 mg/kg | 9 |
| E-602 20 mg/kg | 15 |
| E-602 30 mg/kg | 15 |
| E-602 20 mg/kg in Combination With Cemiplimab | 21 |
Reported measurements
Participants with any Treatment Emergent AE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| E-602 1 mg/kg | 5 | Not reported | Not reported | Not reported | Not reported |
| E-602 3 mg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
| E-602 10 mg/kg | 8 | Not reported | Not reported | Not reported | Not reported |
| E-602 20 mg/kg | 15 | Not reported | Not reported | Not reported | Not reported |
| E-602 30 mg/kg | 15 | Not reported | Not reported | Not reported | Not reported |
| E-602 20 mg/kg in Combination With Cemiplimab | 20 | Not reported | Not reported | Not reported | Not reported |
Participants with any Serious AE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| E-602 1 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| E-602 3 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| E-602 10 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| E-602 20 mg/kg | 6 | Not reported | Not reported | Not reported | Not reported |
| E-602 30 mg/kg | 5 | Not reported | Not reported | Not reported | Not reported |
| E-602 20 mg/kg in Combination With Cemiplimab | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 15
- group Id
- OG004
- value
- 15
- group Id
- OG005
- value
- 20
- title
- Participants with any Treatment Emergent AE
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 5
- title
- Participants with any Serious AE
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 15
- group Id
- OG004
- value
- 15
- group Id
- OG005
- value
- 21
- units
- Participants
- description
- Number of participants who experienced an adverse events (AEs) or a serious adverse event (SAE)
- groups
- description
- Participants received 1 mg/kg E-602 monotherapy administered weekly via IV infusion.
- id
- OG000
- title
- E-602 1 mg/kg
- description
- Participants received 3 mg/kg E-602 monotherapy administered weekly via IV infusion.
- id
- OG001
- title
- E-602 3 mg/kg
- description
- Participants received 10 mg/kg E-602 monotherapy administered weekly via IV infusion.
- id
- OG002
- title
- E-602 10 mg/kg
- description
- Participants received 20 mg/kg E-602 monotherapy administered weekly via IV infusion.
- id
- OG003
- title
- E-602 20 mg/kg
- description
- Participants received 30 mg/kg E-602 monotherapy administered weekly via IV infusion.
- id
- OG004
- title
- E-602 30 mg/kg
- description
- Participants received 20 mg/kg E-602 monotherapy administered weekly via IV infusion. They also received 350 mg cemiplimab administered every 3 weeks via IV infusion.
- id
- OG005
- title
- E-602 20 mg/kg in Combination With Cemiplimab
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- 15 Months
- title
- Number of Participants Who Experienced AEs or SAEs
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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