Trial · NCT01566721
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period | From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year) | 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. The percentage of participants with at least 1 AE during the treatment period (regardless of severity or seriousness) was reported. |
| Primary | Percentage of Participants With a Grade 3 or Higher AE During the Treatment Period | From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year) | 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. |
| Primary | Percentage of Participants With Treatment Interruption Due to an AE | From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year) | 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. The percentage of participants with SC Herceptin treatment interrupted to assess or treat AEs was reported. |
| Primary | Number of Herceptin Cycles Received | From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year) | Participants were planned to receive a total of 18 cycles of SC Herceptin. The median number of cycles actually received was reported. |
| Primary | Percentage of Participants by Total Number of Herceptin Cycles Received | From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year) | Participants were planned to receive a total of 18 cycles of SC Herceptin. The percentage of participants was reported by the total number of cycles actually received. Because the data are presented non-cumulatively, this table reflects participant distribution by the highest number of cycles received. |
| Primary | Percentage of Participants Who Received Concomitant Cancer Therapy | From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years) | Concomitant cancer treatment included chemotherapy, radiotherapy, and hormone therapy administered during the study. The percentage of participants who received any of these concomitant therapies was reported. |
| Primary | Percentage of Participants Who Received Concomitant Non-Cancer Therapy | From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years) | Concomitant non-cancer treatment included any pharmacologic interventions administered during the study other than chemotherapy, radiotherapy, or hormone therapy. The percentage of participants who received any concomitant non-cancer therapies was reported. |
| Secondary | Percentage of Participants Who Died by Data Cutoff of 10 March 2015 | From Baseline to time of event (maximum follow-up approximately 3 years as of data cutoff of 10 March 2015) | The percentage of participants who died from any cause was reported. |
| Secondary | Percentage of Participants Who Died During the Safety Follow-up Period | From Baseline to Time of Event, Safety Follow-Up Period (Up to 6 Years) | The percentage of participants who died from any cause was reported during the safety follow-up period. |
| Secondary | Disease-Free Survival Rate | From Baseline to time of event (up to approximately 8 years) | DFS is defined as the time from first dose of SC Herceptin to the first event of local, regional or distant recurrence, contralateral invasive breast cancer (including ipsilateral ductal carcinoma in situ) or death due to any cause. Time from the date of first dose to any DFS event was expressed in Kaplan-Meier survival probability estimates. Patients without an event will be censored at the last assessment date. |
| Secondary | Overall Survival Rate | From Baseline to Time of Event (Up to Approximately 6 Years) | 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. |
| Secondary | Percentage of Participants by Item Response to SID Satisfaction Questionnaire | Cycle 4 (cycle length 3 weeks) and last safety follow-up (LSFU) (approximately 1 year) | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01566721/registered