TriangleNCT02888743 · OUTCOME
Incidence of Grade 3-5 Adverse Events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- Up to 2 years
What was measured
Assessed by Common Terminology Criteria for Adverse Events version 4.0. The proportions of subjects with grade-3 or higher adverse events (all attributions) are presented with 90% exact binomial confidence intervals.
Analysis population: Participants who received at least one regimen of protocol therapy.
Groups in this outcome
NSCLC Arm A (Tremelimumab, Durvalumab, HD-RT)
Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive high-dose radiation therapy QD over 10 days for up to 3 fractions. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
NSCLC Arm B (Tremelimumab, Durvalumab, LD-RT)
Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive low-dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
NSCLC Arm C (Tremelimumab, Durvalumab)
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Durvalumab: Given IV Tremelimumab: Given IV
CRC Arm A (Tremelimumab, Durvalumab, HD-RT)
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive high-dose radiation therapy QD over 10 days for up to 3 fractions. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
CRC Arm B (Tremelimumab, Durvalumab, LD-RT)
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive low-dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
| Group | Source count |
|---|---|
| NSCLC Arm A (Tremelimumab, Durvalumab, HD-RT) | 26 |
| NSCLC Arm B (Tremelimumab, Durvalumab, LD-RT) | 26 |
| NSCLC Arm C (Tremelimumab, Durvalumab) | 26 |
| CRC Arm A (Tremelimumab, Durvalumab, HD-RT) | 10 |
| CRC Arm B (Tremelimumab, Durvalumab, LD-RT) | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| NSCLC Arm A (Tremelimumab, Durvalumab, HD-RT) | 11.5 | Not reported | 3 | 27 | Not reported |
| NSCLC Arm B (Tremelimumab, Durvalumab, LD-RT) | 30.8 | Not reported | 16 | 49 | Not reported |
| NSCLC Arm C (Tremelimumab, Durvalumab) | 15.4 | Not reported | 5 | 32 | Not reported |
| CRC Arm A (Tremelimumab, Durvalumab, HD-RT) | 70.0 | Not reported | 39 | 91 | Not reported |
| CRC Arm B (Tremelimumab, Durvalumab, LD-RT) | 77.8 | Not reported | 45 | 96 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3
- upper Limit
- 27
- value
- 11.5
- group Id
- OG001
- lower Limit
- 16
- upper Limit
- 49
- value
- 30.8
- group Id
- OG002
- lower Limit
- 5
- upper Limit
- 32
- value
- 15.4
- group Id
- OG003
- lower Limit
- 39
- upper Limit
- 91
- value
- 70.0
- group Id
- OG004
- lower Limit
- 45
- upper Limit
- 96
- value
- 77.8
- denoms
- counts
- group Id
- OG000
- value
- 26
- group Id
- OG001
- value
- 26
- group Id
- OG002
- value
- 26
- group Id
- OG003
- value
- 10
- group Id
- OG004
- value
- 9
- units
- Participants
- description
- Assessed by Common Terminology Criteria for Adverse Events version 4.0. The proportions of subjects with grade-3 or higher adverse events (all attributions) are presented with 90% exact binomial confidence intervals.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive high-dose radiation therapy QD over 10 days for up to 3 fractions. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
- id
- OG000
- title
- NSCLC Arm A (Tremelimumab, Durvalumab, HD-RT)
- description
- Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive low-dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
- id
- OG001
- title
- NSCLC Arm B (Tremelimumab, Durvalumab, LD-RT)
- description
- Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Durvalumab: Given IV Tremelimumab: Given IV
- id
- OG002
- title
- NSCLC Arm C (Tremelimumab, Durvalumab)
- description
- Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive high-dose radiation therapy QD over 10 days for up to 3 fractions. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
- id
- OG003
- title
- CRC Arm A (Tremelimumab, Durvalumab, HD-RT)
- description
- Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive low-dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
- id
- OG004
- title
- CRC Arm B (Tremelimumab, Durvalumab, LD-RT)
- param Type
- NUMBER
- population Description
- Participants who received at least one regimen of protocol therapy.
- reporting Status
- POSTED
- time Frame
- Up to 2 years
- title
- Incidence of Grade 3-5 Adverse Events
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice