TriangleNCT03837899 · OUTCOME
Dose-Finding Phase: Number of Participants With Adverse Events (AE), Serious AE (SAE), AE Leading to Discontinuation of Durvalumab and Tremelimumab, AE of Special Interest (AESI) or AE of Possible Interest (AEPI) Related to Durvalumab and Tremelimumab
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 Day 1 up to 15 months
What was measured
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. Some AEs and higher-level terms were considered AESI or AEPIs and this list of categories were provided by the patient safety team.
Analysis population: The Safety analysis set included all participants who received any amount of study treatment.
Groups in this outcome
Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg
Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg
Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg
Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg
Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
| Group | Source count |
|---|---|
| Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg | 7 |
| Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 11 |
| Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg | 3 |
| Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 8 |
Reported measurements
Any AE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg | 6 | Not reported | Not reported | Not reported | Not reported |
| Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 11 | Not reported | Not reported | Not reported | Not reported |
| Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 7 | Not reported | Not reported | Not reported | Not reported |
Any SAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
AE leading to discontinuation of Durvalumab
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
AE leading to discontinuation of Tremelimumab
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
AESIs or AEPIs related to Durvalumab
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
| Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
AESIs or AEPIs related to Tremelimumab
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 7
- title
- Any AE
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- title
- Any SAE
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- AE leading to discontinuation of Durvalumab
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- AE leading to discontinuation of Tremelimumab
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- title
- AESIs or AEPIs related to Durvalumab
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- title
- AESIs or AEPIs related to Tremelimumab
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 8
- units
- Participants
- description
- An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. Some AEs and higher-level terms were considered AESI or AEPIs and this list of categories were provided by the patient safety team.
- groups
- description
- Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
- id
- OG000
- title
- Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg
- description
- Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
- id
- OG001
- title
- Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg
- description
- Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
- id
- OG002
- title
- Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg
- description
- Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
- id
- OG003
- title
- Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The Safety analysis set included all participants who received any amount of study treatment.
- reporting Status
- POSTED
- time Frame
- From Day 1 up to 15 months
- title
- Dose-Finding Phase: Number of Participants With Adverse Events (AE), Serious AE (SAE), AE Leading to Discontinuation of Durvalumab and Tremelimumab, AE of Special Interest (AESI) or AE of Possible Interest (AEPI) Related to Durvalumab and Tremelimumab
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice