TriangleNCT01196390 · OUTCOME
Number of Participants With Any Cardiac Adverse Events Regardless of Attribution
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 randomization to last follow-up. Maximum follow-up at time of analysis was 8 years.
What was measured
Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event (AE) severity from 1=mild to 5=death. Logistic regression was used to evaluate treatment arm, clinical tumor stage (T stage), Zubrod Performance Status, gender, presence of adenopathy, and age as possible predictors of cardiac adverse events. Results of the final model are reported in the statistical analysis section. Summary adverse event data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.
Analysis population: Eligible participants who started study treatment
Groups in this outcome
Chemoradiation and Trastuzumab (Arm 1)
Radiation therapy with concurrent trastuzumab, paclitaxel, and carboplatin followed by surgery followed by maintenance trastuzumab
Chemoradiation (Arm 2)
Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery
| Group | Source count |
|---|---|
| Chemoradiation and Trastuzumab (Arm 1) | 95 |
| Chemoradiation (Arm 2) | 96 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Chemoradiation and Trastuzumab (Arm 1) | 30 | Not reported | Not reported | Not reported | Not reported |
| Chemoradiation (Arm 2) | 24 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.13
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.86
- group Description
- Logistic regression was used to model the association of treatment arm (Arm 1 vs. 2 \[reference level(RL)\]), T stage (T3 vs.T1,T2 \[RL\]), Zubrod (1,2 vs. 0 \[RL\]), gender (male vs. female \[RL\]), presence of adenopathy (yes vs. no \[RL\]), and age (≥ 60 vs. \<60 \[RL\]) with the occurrence of any cardiac AE, using backwards step-wise model selection requiring p≤0.05 for a covariate to remain in the model. Final model covariates are reported. Age is reported here. No other covariates reported.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.021
- param Type
- Odds Ratio (OR)
- param Value
- 2.35
- statistical Method
- Regression, Logistic
Complete source fields
- analyses
- ci Lower Limit
- 1.13
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.86
- group Description
- Logistic regression was used to model the association of treatment arm (Arm 1 vs. 2 \[reference level(RL)\]), T stage (T3 vs.T1,T2 \[RL\]), Zubrod (1,2 vs. 0 \[RL\]), gender (male vs. female \[RL\]), presence of adenopathy (yes vs. no \[RL\]), and age (≥ 60 vs. \<60 \[RL\]) with the occurrence of any cardiac AE, using backwards step-wise model selection requiring p≤0.05 for a covariate to remain in the model. Final model covariates are reported. Age is reported here. No other covariates reported.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.021
- param Type
- Odds Ratio (OR)
- param Value
- 2.35
- statistical Method
- Regression, Logistic
- classes
- categories
- measurements
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 24
- denoms
- counts
- group Id
- OG000
- value
- 95
- group Id
- OG001
- value
- 96
- units
- Participants
- description
- Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event (AE) severity from 1=mild to 5=death. Logistic regression was used to evaluate treatment arm, clinical tumor stage (T stage), Zubrod Performance Status, gender, presence of adenopathy, and age as possible predictors of cardiac adverse events. Results of the final model are reported in the statistical analysis section. Summary adverse event data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.
- groups
- description
- Radiation therapy with concurrent trastuzumab, paclitaxel, and carboplatin followed by surgery followed by maintenance trastuzumab
- id
- OG000
- title
- Chemoradiation and Trastuzumab (Arm 1)
- description
- Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery
- id
- OG001
- title
- Chemoradiation (Arm 2)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Eligible participants who started study treatment
- reporting Status
- POSTED
- time Frame
- From randomization to last follow-up. Maximum follow-up at time of analysis was 8 years.
- title
- Number of Participants With Any Cardiac Adverse Events Regardless of Attribution
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice