TriangleNCT04334759 · OUTCOME
Grade 3-5 Worst Degree Toxicity Rate
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- proportion of participants
- Interval / dispersion
- Not reported
- Time frame
- AEs were recorded from randomisation until 30 days after last chemotherapy dose or 90 days after last durvalumab, ipilimumab, or nivolumab dose, whichever was longer. The treatment duration ranged from 0 to 36 months.
What was measured
Adverse events (AEs) were graded per CTCAEv5 and the worst grade experienced per participant was recorded. The Grade 3-5 toxicity rate is defined as the proportion of treated participants whose worst grade AE was Grade 3, 4, or 5 at any point during the observation period, regardless of treatment attribution.
Analysis population: The analysis population is comprised of treated patients.
Groups in this outcome
Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance
Durvalumab + Standard Chemotherapy for 4 to 6 cycles, followed by Maintenance with Durvalumab Durvalumab: Durvalumab 1500 milligrams (mg) intravenous (IV) every 3 weeks + Cisplatin 75 mg/m² or Carboplatin AUC 5 IV every 3 weeks + Pemetrexed 500 mg/m² IV every 3 weeks for 4 to 6 cycles, followed by maintenance with Durvalumab 1500 mg IV every 4 weeks
Control Arm for Chemo Cohort: Chemotherapy, Then Observation
Standard Chemotherapy for 4 to 6 cycles, followed by Observation Standard Chemotherapy: Cisplatin 75 mg/m² or Carboplatin AUC 5 IV every 3 weeks + Pemetrexed 500 mg/m² IV every 3 weeks) for 4 to 6 cycles, followed by Observation
Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance
Durvalumab + Standard Chemotherapy for 4 to 6 cycles, followed by Maintenance with Durvalumab Durvalumab: Durvalumab 1500 milligrams (mg) intravenous (IV) every 3 weeks + Cisplatin 75 mg/m² or Carboplatin AUC 5 IV every 3 weeks + Pemetrexed 500 mg/m² IV every 3 weeks for 4 to 6 cycles, followed by maintenance with Durvalumab 1500 mg IV every 4 weeks
Control Arm for IO Cohort: Ipilimumab and Nivolumab
Ipilimumab every 6 weeks and Nivolumab every 2 or 3 weeks for up to 2 years. Ipilimumab and Nivolumab: Ipilimumab 1 mg/kg every 6 weeks and Nivolumab 360 mg every 3 weeks or 3 mg/kg every 2 weeks for up to 2 years
| Group | Source count |
|---|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 112 |
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 55 |
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 17 |
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 23 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 0.563 | Not reported | Not reported | Not reported | Not reported |
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 0.473 | Not reported | Not reported | Not reported | Not reported |
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 0.706 | Not reported | Not reported | Not reported | Not reported |
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 0.739 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0.563
- group Id
- OG001
- value
- 0.473
- group Id
- OG002
- value
- 0.706
- group Id
- OG003
- value
- 0.739
- denoms
- counts
- group Id
- OG000
- value
- 112
- group Id
- OG001
- value
- 55
- group Id
- OG002
- value
- 17
- group Id
- OG003
- value
- 23
- units
- Participants
- description
- Adverse events (AEs) were graded per CTCAEv5 and the worst grade experienced per participant was recorded. The Grade 3-5 toxicity rate is defined as the proportion of treated participants whose worst grade AE was Grade 3, 4, or 5 at any point during the observation period, regardless of treatment attribution.
- groups
- description
- Durvalumab + Standard Chemotherapy for 4 to 6 cycles, followed by Maintenance with Durvalumab Durvalumab: Durvalumab 1500 milligrams (mg) intravenous (IV) every 3 weeks + Cisplatin 75 mg/m² or Carboplatin AUC 5 IV every 3 weeks + Pemetrexed 500 mg/m² IV every 3 weeks for 4 to 6 cycles, followed by maintenance with Durvalumab 1500 mg IV every 4 weeks
- id
- OG000
- title
- Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance
- description
- Standard Chemotherapy for 4 to 6 cycles, followed by Observation Standard Chemotherapy: Cisplatin 75 mg/m² or Carboplatin AUC 5 IV every 3 weeks + Pemetrexed 500 mg/m² IV every 3 weeks) for 4 to 6 cycles, followed by Observation
- id
- OG001
- title
- Control Arm for Chemo Cohort: Chemotherapy, Then Observation
- description
- Durvalumab + Standard Chemotherapy for 4 to 6 cycles, followed by Maintenance with Durvalumab Durvalumab: Durvalumab 1500 milligrams (mg) intravenous (IV) every 3 weeks + Cisplatin 75 mg/m² or Carboplatin AUC 5 IV every 3 weeks + Pemetrexed 500 mg/m² IV every 3 weeks for 4 to 6 cycles, followed by maintenance with Durvalumab 1500 mg IV every 4 weeks
- id
- OG002
- title
- Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance
- description
- Ipilimumab every 6 weeks and Nivolumab every 2 or 3 weeks for up to 2 years. Ipilimumab and Nivolumab: Ipilimumab 1 mg/kg every 6 weeks and Nivolumab 360 mg every 3 weeks or 3 mg/kg every 2 weeks for up to 2 years
- id
- OG003
- title
- Control Arm for IO Cohort: Ipilimumab and Nivolumab
- param Type
- NUMBER
- population Description
- The analysis population is comprised of treated patients.
- reporting Status
- POSTED
- time Frame
- AEs were recorded from randomisation until 30 days after last chemotherapy dose or 90 days after last durvalumab, ipilimumab, or nivolumab dose, whichever was longer. The treatment duration ranged from 0 to 36 months.
- title
- Grade 3-5 Worst Degree Toxicity Rate
- type
- SECONDARY
- unit Of Measure
- proportion of participants
Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0
Preserved source evidence · Not medical advice