NCT01566721 · OUTCOME
Overall Survival Rate
A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer · Source last updated 2021-04-27
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Kaplan-Meier survival probability
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From Baseline to Time of Event (Up to Approximately 6 Years)
What was measured
Overall survival was defined as the time from randomization to death from any cause.
Time from the date of randomization to the date of death was expressed in Kaplan-Meier survival probability estimates. Patients without an event will be censored at the last assessment date.
Analysis population: ITT population: All randomized participants received at least one dose of drug and completed the follow up period
Groups in this outcome
Cohort A: SC Herceptin by Needle/Syringe
Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
Cohort B: SC Herceptin by SIDE
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A: SC Herceptin by Needle/Syringe | 1865 |
|---|
| Cohort B: SC Herceptin by SIDE | 708 |
|---|
Reported measurements
0.5 Year
Values in Kaplan-Meier survival probability · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A: SC Herceptin by Needle/Syringe | 0.999 | Not reported | 0.996 | 1.000 | Not reported |
|---|
| Cohort B: SC Herceptin by SIDE | 0.996 | Not reported | 0.987 | 0.999 | Not reported |
|---|
1 Year
Values in Kaplan-Meier survival probability · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A: SC Herceptin by Needle/Syringe | 0.998 | Not reported | 0.994 | 0.999 | Not reported |
|---|
| Cohort B: SC Herceptin by SIDE | 0.994 | Not reported | 0.985 | 0.998 | Not reported |
|---|
1.5 Year
Values in Kaplan-Meier survival probability · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A: SC Herceptin by Needle/Syringe | 0.993 | Not reported | 0.988 | 0.996 | Not reported |
|---|
| Cohort B: SC Herceptin by SIDE | 0.990 | Not reported | 0.979 | 0.995 | Not reported |
|---|
2 Years
Values in Kaplan-Meier survival probability · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A: SC Herceptin by Needle/Syringe | 0.985 | Not reported | 0.979 | 0.990 | Not reported |
|---|
| Cohort B: SC Herceptin by SIDE | 0.985 | Not reported | 0.973 | 0.992 | Not reported |
|---|
3 Years
Values in Kaplan-Meier survival probability · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A: SC Herceptin by Needle/Syringe | 0.968 | Not reported | 0.958 | 0.975 | Not reported |
|---|
| Cohort B: SC Herceptin by SIDE | 0.960 | Not reported | 0.942 | 0.972 | Not reported |
|---|
4 Years
Values in Kaplan-Meier survival probability · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A: SC Herceptin by Needle/Syringe | 0.947 | Not reported | 0.935 | 0.956 | Not reported |
|---|
| Cohort B: SC Herceptin by SIDE | 0.950 | Not reported | 0.931 | 0.965 | Not reported |
|---|
5 Years
Values in Kaplan-Meier survival probability · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A: SC Herceptin by Needle/Syringe | 0.937 | Not reported | 0.925 | 0.948 | Not reported |
|---|
| Cohort B: SC Herceptin by SIDE | 0.929 | Not reported | 0.907 | 0.947 | Not reported |
|---|
6 Years
Values in Kaplan-Meier survival probability · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A: SC Herceptin by Needle/Syringe | 0.927 | Not reported | 0.913 | 0.938 | Not reported |
|---|
| Cohort B: SC Herceptin by SIDE | 0.921 | Not reported | 0.897 | 0.939 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.996
- upper Limit
- 1.000
- value
- 0.999
- group Id
- OG001
- lower Limit
- 0.987
- upper Limit
- 0.999
- value
- 0.996
- title
- 0.5 Year
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.994
- upper Limit
- 0.999
- value
- 0.998
- group Id
- OG001
- lower Limit
- 0.985
- upper Limit
- 0.998
- value
- 0.994
- title
- 1 Year
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.988
- upper Limit
- 0.996
- value
- 0.993
- group Id
- OG001
- lower Limit
- 0.979
- upper Limit
- 0.995
- value
- 0.990
- title
- 1.5 Year
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.979
- upper Limit
- 0.990
- value
- 0.985
- group Id
- OG001
- lower Limit
- 0.973
- upper Limit
- 0.992
- value
- 0.985
- title
- 2 Years
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.958
- upper Limit
- 0.975
- value
- 0.968
- group Id
- OG001
- lower Limit
- 0.942
- upper Limit
- 0.972
- value
- 0.960
- title
- 3 Years
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.935
- upper Limit
- 0.956
- value
- 0.947
- group Id
- OG001
- lower Limit
- 0.931
- upper Limit
- 0.965
- value
- 0.950
- title
- 4 Years
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.925
- upper Limit
- 0.948
- value
- 0.937
- group Id
- OG001
- lower Limit
- 0.907
- upper Limit
- 0.947
- value
- 0.929
- title
- 5 Years
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.913
- upper Limit
- 0.938
- value
- 0.927
- group Id
- OG001
- lower Limit
- 0.897
- upper Limit
- 0.939
- value
- 0.921
- title
- 6 Years
- denoms
- counts
- group Id
- OG000
- value
- 1865
- group Id
- OG001
- value
- 708
- units
- Participants
- description
- Overall survival was defined as the time from randomization to death from any cause.
Time from the date of randomization to the date of death was expressed in Kaplan-Meier survival probability estimates. Patients without an event will be censored at the last assessment date.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
- id
- OG000
- title
- Cohort A: SC Herceptin by Needle/Syringe
- description
- Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
- id
- OG001
- title
- Cohort B: SC Herceptin by SIDE
- param Type
- NUMBER
- population Description
- ITT population: All randomized participants received at least one dose of drug and completed the follow up period
- reporting Status
- POSTED
- time Frame
- From Baseline to Time of Event (Up to Approximately 6 Years)
- title
- Overall Survival Rate
- type
- SECONDARY
- unit Of Measure
- Kaplan-Meier survival probability
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