TriangleNCT03576131 · OUTCOME
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
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
- Day 1 through Day 565 (corresponding to maximum observed duration)
What was measured
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is defined as an AE that meets one of the following criteria: fatal or life-threatening; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; medically significant (an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above \[medical and scientific judgment must be exercised in deciding whether an AE is 'medically important'\]); required inpatient hospitalization or prolongation of existing hospitalization. A TEAE is defined as an AE occurring or worsening during the treatment period including the safety follow-up period.
Analysis population: The Safety Set consists of all participants who received at least one dose of GEN1029 and analyzed according to the actual trial treatment received.
Groups in this outcome
Biweekly Regimen (GEN1029 0.1 mg/kg)
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
Biweekly Regimen (GEN1029 0.2 mg/kg)
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
Biweekly Regimen (GEN1029 0.3 mg/kg)
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
Biweekly Regimen (GEN1029 1.0 mg/kg)
Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
Biweekly Regimen (GEN1029 2.0 mg/kg)
Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
Biweekly Regimen (GEN1029 3.0 mg/kg)
Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
| Group | Source count |
|---|---|
| Biweekly Regimen (GEN1029 0.1 mg/kg) | 10 |
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 7 |
| Biweekly Regimen (GEN1029 0.3 mg/kg) | 4 |
| Biweekly Regimen (GEN1029 1.0 mg/kg) | 11 |
| Biweekly Regimen (GEN1029 2.0 mg/kg) | 7 |
| Biweekly Regimen (GEN1029 3.0 mg/kg) | 7 |
Reported measurements
Any TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Biweekly Regimen (GEN1029 0.1 mg/kg) | 8 | Not reported | Not reported | Not reported | Not reported |
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 7 | Not reported | Not reported | Not reported | Not reported |
| Biweekly Regimen (GEN1029 0.3 mg/kg) | 4 | Not reported | Not reported | Not reported | Not reported |
| Biweekly Regimen (GEN1029 1.0 mg/kg) | 11 | Not reported | Not reported | Not reported | Not reported |
| Biweekly Regimen (GEN1029 2.0 mg/kg) | 7 | Not reported | Not reported | Not reported | Not reported |
| Biweekly Regimen (GEN1029 3.0 mg/kg) | 7 | Not reported | Not reported | Not reported | Not reported |
Any TESAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Biweekly Regimen (GEN1029 0.1 mg/kg) | 3 | Not reported | Not reported | Not reported | Not reported |
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 3 | Not reported | Not reported | Not reported | Not reported |
| Biweekly Regimen (GEN1029 0.3 mg/kg) | 2 | Not reported | Not reported | Not reported | Not reported |
| Biweekly Regimen (GEN1029 1.0 mg/kg) | 9 | Not reported | Not reported | Not reported | Not reported |
| Biweekly Regimen (GEN1029 2.0 mg/kg) | 6 | Not reported | Not reported | Not reported | Not reported |
| Biweekly Regimen (GEN1029 3.0 mg/kg) | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 11
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 7
- title
- Any TEAE
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 4
- title
- Any TESAE
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 11
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 7
- units
- Participants
- description
- An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is defined as an AE that meets one of the following criteria: fatal or life-threatening; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; medically significant (an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above \[medical and scientific judgment must be exercised in deciding whether an AE is 'medically important'\]); required inpatient hospitalization or prolongation of existing hospitalization. A TEAE is defined as an AE occurring or worsening during the treatment period including the safety follow-up period.
- groups
- description
- Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
- id
- OG000
- title
- Biweekly Regimen (GEN1029 0.1 mg/kg)
- description
- Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
- id
- OG001
- title
- Biweekly Regimen (GEN1029 0.2 mg/kg)
- description
- Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
- id
- OG002
- title
- Biweekly Regimen (GEN1029 0.3 mg/kg)
- description
- Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
- id
- OG003
- title
- Biweekly Regimen (GEN1029 1.0 mg/kg)
- description
- Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
- id
- OG004
- title
- Biweekly Regimen (GEN1029 2.0 mg/kg)
- description
- Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
- id
- OG005
- title
- Biweekly Regimen (GEN1029 3.0 mg/kg)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The Safety Set consists of all participants who received at least one dose of GEN1029 and analyzed according to the actual trial treatment received.
- reporting Status
- POSTED
- time Frame
- Day 1 through Day 565 (corresponding to maximum observed duration)
- title
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice