Trial · NCT01566721
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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) | Safety Population: All enrolled participants who received at least one dose of study medication according to assigned treatment. | percentage of participants | NUMBER |
| 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) | Safety Population | percentage of participants | NUMBER |
| 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) | Safety Population | percentage of participants | NUMBER |
| PRIMARY | Number of Herceptin Cycles Received | From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year) | Safety Population. The endpoint also included an analysis of a subgroup of participants from Cohort B who received doses of self-administered SC Herceptin via SID. | cycles | MEDIAN |
| 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) | Safety Population. The endpoint also included an analysis of a subgroup of participants from Cohort B who received doses of self-administered SC Herceptin via SID. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Received Concomitant Cancer Therapy | From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years) | Safety Population | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Received Concomitant Non-Cancer Therapy | From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years) | Safety Population | percentage of participants | NUMBER |
| 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) | ITT Population | percentage of participants | NUMBER |
| 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) | ITT Population | Percentage of Participants | NUMBER |
| SECONDARY | Disease-Free Survival Rate | From Baseline to time of event (up to approximately 8 years) | ITT Population who completed Safety Follow-up | Kaplan-Meier survival probability | NUMBER |
| SECONDARY | Overall Survival Rate | From Baseline to Time of Event (Up to Approximately 6 Years) | ITT population: All randomized participants received at least one dose of drug and completed the follow up period | Kaplan-Meier survival probability | NUMBER |
| 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) | 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. | percentage of participants | NUMBER |
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/outcomes