TriangleNCT00045032 · OUTCOME
OS Rate According to Kaplan-Meier Analysis Compared to Observation: 11-Year Median Follow-Up
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
- Years 3, 5, 7, 9, 10, 11, 12
What was measured
OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with an 11-year median follow-up for OS events.
Analysis population: FAS Population
Groups in this outcome
Observation Arm
Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
Herceptin 1-Year Arm
Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
Herceptin 2-Year Arm
Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
| Group | Source count |
|---|---|
| Observation Arm | 1697 |
| Herceptin 1-Year Arm | 1702 |
| Herceptin 2-Year Arm | 1700 |
Reported measurements
Year 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Observation Arm | 90.7 | Not reported | 89.3 | 92.1 | Not reported |
| Herceptin 1-Year Arm | 92.7 | Not reported | 91.5 | 94.0 | Not reported |
| Herceptin 2-Year Arm | 94.4 | Not reported | 93.3 | 95.6 | Not reported |
Year 5
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Observation Arm | 84.5 | Not reported | 82.8 | 86.3 | Not reported |
| Herceptin 1-Year Arm | 86.9 | Not reported | 85.2 | 88.5 | Not reported |
| Herceptin 2-Year Arm | 88.7 | Not reported | 87.2 | 90.3 | Not reported |
Year 7
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Observation Arm | 79.4 | Not reported | 77.4 | 81.4 | Not reported |
| Herceptin 1-Year Arm | 83.8 | Not reported | 82.0 | 85.6 | Not reported |
| Herceptin 2-Year Arm | 84.7 | Not reported | 82.9 | 86.4 | Not reported |
Year 9
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Observation Arm | 76.5 | Not reported | 74.4 | 78.6 | Not reported |
| Herceptin 1-Year Arm | 81.9 | Not reported | 80.0 | 83.8 | Not reported |
| Herceptin 2-Year Arm | 81.8 | Not reported | 80.0 | 83.7 | Not reported |
Year 10
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Observation Arm | 75.0 | Not reported | 72.9 | 77.2 | Not reported |
| Herceptin 1-Year Arm | 80.7 | Not reported | 78.8 | 82.6 | Not reported |
| Herceptin 2-Year Arm | 81.0 | Not reported | 79.0 | 82.9 | Not reported |
Year 11
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Observation Arm | 73.7 | Not reported | 71.5 | 76.0 | Not reported |
| Herceptin 1-Year Arm | 80.0 | Not reported | 78.1 | 82.0 | Not reported |
| Herceptin 2-Year Arm | 80.3 | Not reported | 78.3 | 82.3 | Not reported |
Year 12
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Observation Arm | 72.9 | Not reported | 70.4 | 75.3 | Not reported |
| Herceptin 1-Year Arm | 79.4 | Not reported | 77.3 | 81.5 | Not reported |
| Herceptin 2-Year Arm | 79.5 | Not reported | 77.4 | 81.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 89.3
- upper Limit
- 92.1
- value
- 90.7
- group Id
- OG001
- lower Limit
- 91.5
- upper Limit
- 94.0
- value
- 92.7
- group Id
- OG002
- lower Limit
- 93.3
- upper Limit
- 95.6
- value
- 94.4
- title
- Year 3
- categories
- measurements
- group Id
- OG000
- lower Limit
- 82.8
- upper Limit
- 86.3
- value
- 84.5
- group Id
- OG001
- lower Limit
- 85.2
- upper Limit
- 88.5
- value
- 86.9
- group Id
- OG002
- lower Limit
- 87.2
- upper Limit
- 90.3
- value
- 88.7
- title
- Year 5
- categories
- measurements
- group Id
- OG000
- lower Limit
- 77.4
- upper Limit
- 81.4
- value
- 79.4
- group Id
- OG001
- lower Limit
- 82.0
- upper Limit
- 85.6
- value
- 83.8
- group Id
- OG002
- lower Limit
- 82.9
- upper Limit
- 86.4
- value
- 84.7
- title
- Year 7
- categories
- measurements
- group Id
- OG000
- lower Limit
- 74.4
- upper Limit
- 78.6
- value
- 76.5
- group Id
- OG001
- lower Limit
- 80.0
- upper Limit
- 83.8
- value
- 81.9
- group Id
- OG002
- lower Limit
- 80.0
- upper Limit
- 83.7
- value
- 81.8
- title
- Year 9
- categories
- measurements
- group Id
- OG000
- lower Limit
- 72.9
- upper Limit
- 77.2
- value
- 75.0
- group Id
- OG001
- lower Limit
- 78.8
- upper Limit
- 82.6
- value
- 80.7
- group Id
- OG002
- lower Limit
- 79.0
- upper Limit
- 82.9
- value
- 81.0
- title
- Year 10
- categories
- measurements
- group Id
- OG000
- lower Limit
- 71.5
- upper Limit
- 76.0
- value
- 73.7
- group Id
- OG001
- lower Limit
- 78.1
- upper Limit
- 82.0
- value
- 80.0
- group Id
- OG002
- lower Limit
- 78.3
- upper Limit
- 82.3
- value
- 80.3
- title
- Year 11
- categories
- measurements
- group Id
- OG000
- lower Limit
- 70.4
- upper Limit
- 75.3
- value
- 72.9
- group Id
- OG001
- lower Limit
- 77.3
- upper Limit
- 81.5
- value
- 79.4
- group Id
- OG002
- lower Limit
- 77.4
- upper Limit
- 81.7
- value
- 79.5
- title
- Year 12
- denoms
- counts
- group Id
- OG000
- value
- 1697
- group Id
- OG001
- value
- 1702
- group Id
- OG002
- value
- 1700
- units
- Participants
- description
- OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with an 11-year median follow-up for OS events.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
- id
- OG000
- title
- Observation Arm
- description
- Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
- id
- OG001
- title
- Herceptin 1-Year Arm
- description
- Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
- id
- OG002
- title
- Herceptin 2-Year Arm
- param Type
- NUMBER
- population Description
- FAS Population
- reporting Status
- POSTED
- time Frame
- Years 3, 5, 7, 9, 10, 11, 12
- title
- OS Rate According to Kaplan-Meier Analysis Compared to Observation: 11-Year Median Follow-Up
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice