NCT01566721 · OUTCOME

Percentage of Participants by Item Response to SID Satisfaction Questionnaire

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: percentage of participants
Interval / dispersion: Not reported
Time frame: Cycle 4 (cycle length 3 weeks) and last safety follow-up (LSFU) (approximately 1 year)

What was measured

The SID satisfaction questionnaire was administered twice during the study and asked participants to respond to five statements using a Likert scale from "Strongly Disagree" to "Strongly Agree". Questionnaire items were as follows: "I felt comfortable injecting the study drug by myself" (Comfortable), "The SID was convenient and easy to use" (Easy to Use), "I am confident giving myself an injection in the thigh with the SID" (Confident), "Taking all things into account I find self-administration using the SID satisfactory" (Satisfactory), "If given the opportunity I would choose to continue self-injecting the study drug using the SID in the future" (Continue). Participants could only select one response per questionnaire item. There was no calculation of any score, but rather, descriptive summaries were generated by item response. The percentage of participants was reported by the response given for each item on the SID satisfaction questionnaire.

Analysis population: Safety Population. Only participants who performed self-administration were included. The number of participants who responded to the questionnaire item at each assessment (n) is shown in the table.

Groups in this outcome

Cohort B: SC Herceptin by SID (Self- Administered)

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. Dosing was either performed by self-administration or a qualified HCP. The present subgroup included only participants for whom SC Herceptin was given by self- administration.

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 B: SC Herceptin by SID (Self- Administered)	550

Reported measurements

Cycle 4: Comfortable, Strongly Disagree (n=514)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	4.7	Not reported	Not reported	Not reported	Not reported

Cycle 4: Comfortable, Disagree (n=514)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	2.3	Not reported	Not reported	Not reported	Not reported

Cycle 4: Comfortable, Unsure (n=514)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	7.6	Not reported	Not reported	Not reported	Not reported

Cycle 4: Comfortable, Agree (n=514)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	41.6	Not reported	Not reported	Not reported	Not reported

Cycle 4: Comfortable, Strongly Agree (n=514)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	43.6	Not reported	Not reported	Not reported	Not reported

Cycle 4: Comfortable, Response Missing (n=514)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	0.2	Not reported	Not reported	Not reported	Not reported

Cycle 4: Easy to Use, Strongly Disagree (n=514)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	3.7	Not reported	Not reported	Not reported	Not reported

Cycle 4: Easy to Use, Disagree (n=514)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	0.6	Not reported	Not reported	Not reported	Not reported

Cycle 4: Easy to Use, Unsure (n=514)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	1.8	Not reported	Not reported	Not reported	Not reported

Cycle 4: Easy to Use, Agree (n=514)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	37.7	Not reported	Not reported	Not reported	Not reported

Cycle 4: Easy to Use, Strongly Agree (n=514)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	56.0	Not reported	Not reported	Not reported	Not reported

Cycle 4: Easy to Use, Response Missing (n=514)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	0.2	Not reported	Not reported	Not reported	Not reported

Cycle 4: Confident, Strongly Disagree (n=514)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	3.9	Not reported	Not reported	Not reported	Not reported

Cycle 4: Confident, Disagree (n=514)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	0.8	Not reported	Not reported	Not reported	Not reported

Cycle 4: Confident, Unsure (n=514)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	7.2	Not reported	Not reported	Not reported	Not reported

Cycle 4: Confident, Agree (n=514)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	42.8	Not reported	Not reported	Not reported	Not reported

Cycle 4: Confident, Strongly Agree (n=514)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	45.1	Not reported	Not reported	Not reported	Not reported

Cycle 4: Confident, Response Missing (n=514)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	0.2	Not reported	Not reported	Not reported	Not reported

Cycle 4: Satisfactory, Strongly Disagree (n=514)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	3.9	Not reported	Not reported	Not reported	Not reported

Cycle 4: Satisfactory, Disagree (n=514)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	0.6	Not reported	Not reported	Not reported	Not reported

Cycle 4: Satisfactory, Unsure (n=514)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	2.7	Not reported	Not reported	Not reported	Not reported

Cycle 4: Satisfactory, Agree (n=514)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	38.7	Not reported	Not reported	Not reported	Not reported

Cycle 4: Satisfactory, Strongly Agree (n=514)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	53.9	Not reported	Not reported	Not reported	Not reported

Cycle 4: Satisfactory, Response Missing (n=514)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	0.2	Not reported	Not reported	Not reported	Not reported

Cycle 4: Continue, Strongly Disagree (n=514)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	3.9	Not reported	Not reported	Not reported	Not reported

Cycle 4: Continue, Disagree (n=514)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	1.4	Not reported	Not reported	Not reported	Not reported

Cycle 4: Continue, Unsure (n=514)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	5.3	Not reported	Not reported	Not reported	Not reported

Cycle 4: Continue, Agree (n=514)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	33.5	Not reported	Not reported	Not reported	Not reported

Cycle 4: Continue, Strongly Agree (n=514)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	55.8	Not reported	Not reported	Not reported	Not reported

Cycle 4: Continue, Response Missing (n=514)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	0.2	Not reported	Not reported	Not reported	Not reported

LSFU: Comfortable, Strongly Disagree (n=415)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	3.6	Not reported	Not reported	Not reported	Not reported

LSFU: Comfortable, Disagree (n=415)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	3.1	Not reported	Not reported	Not reported	Not reported

LSFU: Comfortable, Unsure (n=415)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	5.3	Not reported	Not reported	Not reported	Not reported

LSFU: Comfortable, Agree (n=415)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	35.9	Not reported	Not reported	Not reported	Not reported

LSFU: Comfortable, Strongly Agree (n=415)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	51.8	Not reported	Not reported	Not reported	Not reported

LSFU: Comfortable, Response Missing (n=415)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	0.2	Not reported	Not reported	Not reported	Not reported

LSFU: Easy to Use, Strongly Disagree (n=415)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	3.9	Not reported	Not reported	Not reported	Not reported

LSFU: Easy to Use, Disagree (n=415)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	1.0	Not reported	Not reported	Not reported	Not reported

LSFU: Easy to Use, Unsure (n=415)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	1.7	Not reported	Not reported	Not reported	Not reported

LSFU: Easy to Use, Agree (n=415)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	34.9	Not reported	Not reported	Not reported	Not reported

LSFU: Easy to Use, Strongly Agree (n=415)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	58.6	Not reported	Not reported	Not reported	Not reported

LSFU: Easy to Use, Response Missing (n=415)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	0	Not reported	Not reported	Not reported	Not reported

LSFU: Confident, Strongly Disagree (n=415)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	4.6	Not reported	Not reported	Not reported	Not reported

LSFU: Confident, Disagree (n=415)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	1.2	Not reported	Not reported	Not reported	Not reported

LSFU: Confident, Unsure (n=415)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	4.3	Not reported	Not reported	Not reported	Not reported

LSFU: Confident, Agree (n=415)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	33.3	Not reported	Not reported	Not reported	Not reported

LSFU: Confident, Strongly Agree (n=415)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	56.6	Not reported	Not reported	Not reported	Not reported

LSFU: Confident, Response Missing (n=415)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	0	Not reported	Not reported	Not reported	Not reported

LSFU: Satisfactory, Strongly Disagree (n=415)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	4.3	Not reported	Not reported	Not reported	Not reported

LSFU: Satisfactory, Disagree (n=415)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	1.2	Not reported	Not reported	Not reported	Not reported

LSFU: Satisfactory, Unsure (n=415)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	2.2	Not reported	Not reported	Not reported	Not reported

LSFU: Satisfactory, Agree (n=415)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	30.8	Not reported	Not reported	Not reported	Not reported

LSFU: Satisfactory, Strongly Agree (n=415)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	61.2	Not reported	Not reported	Not reported	Not reported

LSFU: Satisfactory, Response Missing (n=415)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	0.2	Not reported	Not reported	Not reported	Not reported

LSFU: Continue, Strongly Disagree (n=415)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	4.6	Not reported	Not reported	Not reported	Not reported

LSFU: Continue, Disagree (n=415)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	1.2	Not reported	Not reported	Not reported	Not reported

LSFU: Continue, Unsure (n=415)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	2.9	Not reported	Not reported	Not reported	Not reported

LSFU: Continue, Agree (n=415)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	28.2	Not reported	Not reported	Not reported	Not reported

LSFU: Continue, Strongly Agree (n=415)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	63.1	Not reported	Not reported	Not reported	Not reported

LSFU: Continue, Response Missing (n=415)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort B: SC Herceptin by SID (Self- Administered)	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
4.7
title
Cycle 4: Comfortable, Strongly Disagree (n=514)
categories
measurements
group Id
OG000
value
2.3
title
Cycle 4: Comfortable, Disagree (n=514)
categories
measurements
group Id
OG000
value
7.6
title
Cycle 4: Comfortable, Unsure (n=514)
categories
measurements
group Id
OG000
value
41.6
title
Cycle 4: Comfortable, Agree (n=514)
categories
measurements
group Id
OG000
value
43.6
title
Cycle 4: Comfortable, Strongly Agree (n=514)
categories
measurements
group Id
OG000
value
0.2
title
Cycle 4: Comfortable, Response Missing (n=514)
categories
measurements
group Id
OG000
value
3.7
title
Cycle 4: Easy to Use, Strongly Disagree (n=514)
categories
measurements
group Id
OG000
value
0.6
title
Cycle 4: Easy to Use, Disagree (n=514)
categories
measurements
group Id
OG000
value
1.8
title
Cycle 4: Easy to Use, Unsure (n=514)
categories
measurements
group Id
OG000
value
37.7
title
Cycle 4: Easy to Use, Agree (n=514)
categories
measurements
group Id
OG000
value
56.0
title
Cycle 4: Easy to Use, Strongly Agree (n=514)
categories
measurements
group Id
OG000
value
0.2
title
Cycle 4: Easy to Use, Response Missing (n=514)

denoms

counts
group Id
OG000
value
550
units
Participants

description

groups

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. Dosing was either performed by self-administration or a qualified HCP. The present subgroup included only participants for whom SC Herceptin was given by self- administration.
id
OG000
title
Cohort B: SC Herceptin by SID (Self- Administered)

param Type

NUMBER

population Description

Safety Population. Only participants who performed self-administration were included. The number of participants who responded to the questionnaire item at each assessment (n) is shown in the table.

reporting Status

POSTED

time Frame

Cycle 4 (cycle length 3 weeks) and last safety follow-up (LSFU) (approximately 1 year)

title

Percentage of Participants by Item Response to SID Satisfaction Questionnaire

type

SECONDARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice