NCT02445391 · OUTCOME
3-year Overall Survival (OS) Rate in Basal-Subtype Patients
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
- 95% Confidence Interval
- Time frame
- Assessed every 3 months within 2 years from randomization, every 6 months if 2-3 years
What was measured
OS was defined as time from randomization to death from any cause. Patient alive were censored at date of known alive. The 3-year OS rate was estimated using Kaplan-Meier method.
Analysis population: The primary analysis population was all basal-subtype TNBC patients who were concurrently randomized to arms B and C after 6/22/2016 (intent-to-treat population).
Groups in this outcome
Arm B (Cisplatin or Carboplatin) (Enrolled While Arm C Was Open)
Patients receive cisplatin IV or carboplatin IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV
Arm C (Capecitabine) (Open to Accrual 6/22/2016)
Patients receive capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO
| Group | Source count |
|---|---|
| Arm B (Cisplatin or Carboplatin) (Enrolled While Arm C Was Open) | 148 |
| Arm C (Capecitabine) (Open to Accrual 6/22/2016) | 160 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm B (Cisplatin or Carboplatin) (Enrolled While Arm C Was Open) | 57.8 | Not reported | 45.2 | 68.4 | Not reported |
| Arm C (Capecitabine) (Open to Accrual 6/22/2016) | 66.2 | Not reported | 56.3 | 74.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 45.2
- upper Limit
- 68.4
- value
- 57.8
- group Id
- OG001
- lower Limit
- 56.3
- upper Limit
- 74.3
- value
- 66.2
- denoms
- counts
- group Id
- OG000
- value
- 148
- group Id
- OG001
- value
- 160
- units
- Participants
- description
- OS was defined as time from randomization to death from any cause. Patient alive were censored at date of known alive. The 3-year OS rate was estimated using Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive cisplatin IV or carboplatin IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV
- id
- OG000
- title
- Arm B (Cisplatin or Carboplatin) (Enrolled While Arm C Was Open)
- description
- Patients receive capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO
- id
- OG001
- title
- Arm C (Capecitabine) (Open to Accrual 6/22/2016)
- param Type
- NUMBER
- population Description
- The primary analysis population was all basal-subtype TNBC patients who were concurrently randomized to arms B and C after 6/22/2016 (intent-to-treat population).
- reporting Status
- POSTED
- time Frame
- Assessed every 3 months within 2 years from randomization, every 6 months if 2-3 years
- title
- 3-year Overall Survival (OS) Rate in Basal-Subtype Patients
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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