TriangleNCT01566721 · OUTCOME
Percentage of Participants With a Grade 3 or Higher AE During the Treatment Period
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
- From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
What was measured
Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. AEs were graded according to National Cancer Institute Common Terminology Criteria Version 4.0. Grade 3 AEs were those considered severe or medically significant but not immediately life-threatening. Grade 4 AEs were those considered life-threatening and/or for which urgent intervention was indicated. Grade 5 AEs were those resulting in death. The percentage of participants with a Grade 3 or higher (i.e., Grade 3 to 5) AE during the treatment period was reported.
Analysis population: Safety Population
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 SID
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 | Source count |
|---|---|
| Cohort A: SC Herceptin by Needle/Syringe | 1864 |
| Cohort B: SC Herceptin by SID | 709 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: SC Herceptin by Needle/Syringe | 24.0 | Not reported | 22.1 | 26.0 | Not reported |
| Cohort B: SC Herceptin by SID | 21.0 | Not reported | 18.1 | 24.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 22.1
- upper Limit
- 26.0
- value
- 24.0
- group Id
- OG001
- lower Limit
- 18.1
- upper Limit
- 24.2
- value
- 21.0
- denoms
- counts
- group Id
- OG000
- value
- 1864
- group Id
- OG001
- value
- 709
- units
- Participants
- description
- Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. AEs were graded according to National Cancer Institute Common Terminology Criteria Version 4.0. Grade 3 AEs were those considered severe or medically significant but not immediately life-threatening. Grade 4 AEs were those considered life-threatening and/or for which urgent intervention was indicated. Grade 5 AEs were those resulting in death. The percentage of participants with a Grade 3 or higher (i.e., Grade 3 to 5) AE during the treatment period was reported.
- 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 SID
- param Type
- NUMBER
- population Description
- Safety Population
- reporting Status
- POSTED
- time Frame
- From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
- title
- Percentage of Participants With a Grade 3 or Higher AE During the Treatment Period
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice