TriangleNCT03075527 · OUTCOME
Grade 4-5 Treatment-related 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 paticipants
- Interval / dispersion
- 80% Confidence Interval
- Time frame
- Toxicity is assessed from the time of first dose of study medication until the participant comes off study. The median of treatment duration is 1.91 months with range (0.00 months - 23.46 months).
What was measured
All grade 4-5 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4.03 that are not resolved in accordance with treatment guidelines were counted. Rate is the proportion of treated participants experiencing at least one of these adverse events as defined during the time of observation.
Analysis population: This analysis dataset is comprised of all eligible and treated patients.
Groups in this outcome
Tremelimumab + Durvalumab
Subjects will receive durvalumab and tremelimumab both via intravenous infusion once per day for every 28 day cycles (+ 7 days). Participants will receive tremelimumab for up to 4 cycles (4 doses). Beginning with cycle 5 day 1, subjects will continue to receive durvalumab alone, until clinical or radiological progression. Tremelimumab: Tremelimumab blocks a receptor on immune cells that normally suppresses immune attack. Durvalumab: Durvalumab is a drug that blocks a protein often produced by cancer cells or surrounding cells to suppress immune cells from attacking cancer cells.
| Group | Source count |
|---|---|
| Tremelimumab + Durvalumab | 19 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tremelimumab + Durvalumab | 0.158 | Not reported | 0.061 | 0.322 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.061
- upper Limit
- 0.322
- value
- 0.158
- denoms
- counts
- group Id
- OG000
- value
- 19
- units
- Participants
- description
- All grade 4-5 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4.03 that are not resolved in accordance with treatment guidelines were counted. Rate is the proportion of treated participants experiencing at least one of these adverse events as defined during the time of observation.
- dispersion Type
- 80% Confidence Interval
- groups
- description
- Subjects will receive durvalumab and tremelimumab both via intravenous infusion once per day for every 28 day cycles (+ 7 days). Participants will receive tremelimumab for up to 4 cycles (4 doses). Beginning with cycle 5 day 1, subjects will continue to receive durvalumab alone, until clinical or radiological progression. Tremelimumab: Tremelimumab blocks a receptor on immune cells that normally suppresses immune attack. Durvalumab: Durvalumab is a drug that blocks a protein often produced by cancer cells or surrounding cells to suppress immune cells from attacking cancer cells.
- id
- OG000
- title
- Tremelimumab + Durvalumab
- param Type
- NUMBER
- population Description
- This analysis dataset is comprised of all eligible and treated patients.
- reporting Status
- POSTED
- time Frame
- Toxicity is assessed from the time of first dose of study medication until the participant comes off study. The median of treatment duration is 1.91 months with range (0.00 months - 23.46 months).
- title
- Grade 4-5 Treatment-related Toxicity Rate
- type
- SECONDARY
- unit Of Measure
- proportion of paticipants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice