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| ID | Type | Description | Link |
|---|---|---|---|
| BIG-01-01 | |||
| EU-20216 | |||
| ROCHE-B016348E | |||
| ROCHE-B016348C | |||
| EORTC-10011 | |||
| CAN-NCIC-MA24 | |||
| IBCSG-28-02 |
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| Name | Class |
|---|---|
| Breast International Group | OTHER |
| European Organisation for Research and Treatment of Cancer - EORTC | NETWORK |
| NCIC Clinical Trials Group | NETWORK |
The purpose of this trial is to evaluate Herceptin treatment for 1 year and 2 years (versus observation/no Herceptin) in women with HER2-overexpressing primary breast cancer who have completed (neo-)adjuvant systemic chemotherapy, definitive surgery, and radiotherapy, if applicable. Efficacy and safety will be assessed for 10 years from randomization for each participant. All participants will continue to be followed for survival until 10 years after enrollment of the last participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation Arm | No Intervention | Participants who have completed definitive surgery and systemic adjuvant chemotherapy will be observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin will be provided. | |
| Herceptin 1-Year Arm | Experimental | Participants who have completed definitive surgery and systemic adjuvant chemotherapy will receive Herceptin for 1 year or until disease recurrence, whichever occurs first. Participants will be observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. |
|
| Herceptin 2-Year Arm | Experimental | Participants who have completed definitive surgery and systemic adjuvant chemotherapy will receive Herceptin for 2 years or until disease recurrence, whichever occurs first. Participants will be observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Herceptin | Drug | Herceptin will be given as a loading dose of 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Disease-Free Survival (DFS) Events in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an Independent Data Monitoring Committee (IDMC) in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure. | From Baseline until time of event (median of 1 year) |
| Percentage of Participants With DFS Events in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure. | From Baseline until time of event (median of 1 year) |
| DFS Rate According to Kaplan-Meier Analysis in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95 percent (%) confidence interval (CI) were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an IDMC in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With DFS Events in 1-Year Versus 2-Year Herceptin: 10-Year Maximum Follow-Up | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martine J. Piccart-Gebhart, MD, PhD | Jules Bordet Institute | Study Chair |
| Robert E. Coleman, MD, FRCP | Cancer Research Centre at Weston Park Hospital | Study Chair |
| Karen A. Gelmon, MD | British Columbia Cancer Agency | Study Chair |
| Kathleen I. Pritchard, MD | Toronto Sunnybrook Regional Cancer Centre | Study Chair |
| Olivia Pagani, MD | Ospedale Beata Vergine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Aleman de Buenos Aires | Buenos Aires | Buenos Aires | 1118 | Argentina | ||
| Saint John of God Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18757259 | Background | Jahanzeb M. Adjuvant trastuzumab therapy for HER2-positive breast cancer. Clin Breast Cancer. 2008 Aug;8(4):324-33. doi: 10.3816/CBC.2008.n.037. | |
| 17661170 | Background | Shiroiwa T, Fukuda T, Shimozuma K, Ohashi Y, Tsutani K. The model-based cost-effectiveness analysis of 1-year adjuvant trastuzumab treatment: based on 2-year follow-up HERA trial data. Breast Cancer Res Treat. 2008 Jun;109(3):559-66. doi: 10.1007/s10549-007-9679-4. Epub 2007 Jul 28. |
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After the release of initial study results, participants in the Observation Arm without disease recurrence were given the opportunity to cross over to receive 1 or 2 years of adjuvant Herceptin. Efficacy analyses were still performed according to original randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | Observation Arm | Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ETOP IBCSG Partners Foundation |
| NETWORK |
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|
| Herceptin | Drug | Herceptin will be given as a loading dose of 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks. |
|
|
| Year 2 |
| DFS Rate According to Kaplan-Meier Analysis in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure. | Year 2 |
| Percentage of Participants With DFS Events Compared to Observation: 8-Year Median Follow-Up | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported. | From Baseline until time of event (median of 8 years) |
| DFS Rate at Year 3 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. | Year 3 |
| DFS Rate at Year 5 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. | Year 5 |
| DFS Rate at Year 7 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. | Year 7 |
| DFS Rate at Year 8 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. | Year 8 |
| Percentage of Participants With DFS Events Compared to Observation: 10-Year Maximum Follow-Up | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported. | From Baseline until time of event (maximum of 10 years) |
| DFS Rate at Year 3 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events. | Year 3 |
| DFS Rate at Year 5 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events. | Year 5 |
| DFS Rate at Year 7 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events. | Year 7 |
| DFS Rate at Year 8 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events. | Year 8 |
| DFS Rate at Year 9 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events. | Year 9 |
| DFS Rate at Year 10 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events. | Year 10 |
| From Baseline until time of event (maximum of 10 years) |
| DFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 10-Year Maximum Follow-Up | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events. | Years 3, 5, 7, 8, 9, 10 |
| Percentage of Participants With Overall Survival (OS) Events in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up | OS events referred to death from any cause. The percentage of participants who died was reported. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an IDMC in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure. | From Baseline until time of event (median of 1 year) |
| Percentage of Participants With OS Events in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up | OS events referred to death from any cause. The percentage of participants who died was reported. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure. | From Baseline until time of event (median of 1 year) |
| OS Rate According to Kaplan-Meier Analysis in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up | OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an IDMC in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure. | Year 2 |
| OS Rate According to Kaplan-Meier Analysis in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up | OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure. | Year 2 |
| Percentage of Participants With OS Events Compared to Observation: 8-Year Median Follow-Up | OS events referred to death from any cause. The percentage of participants who died was reported. | From Baseline until time of event (median of 8 years) |
| OS Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up | OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. | Years 3, 5, 7, 8 |
| Percentage of Participants With OS Events Compared to Observation: 11-Year Median Follow-Up | OS events referred to death from any cause. The percentage of participants who died was reported. | From Baseline until time of event (median of 11 years) |
| OS Rate According to Kaplan-Meier Analysis Compared to Observation: 11-Year Median Follow-Up | OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with an 11-year median follow-up for OS events. | Years 3, 5, 7, 9, 10, 11, 12 |
| Percentage of Participants With OS Events in 1-Year Versus 2-Year Herceptin: 11-Year Median Follow-Up | OS events referred to death from any cause. The percentage of participants who died was reported. | From Baseline until time of event (median of 11 years) |
| OS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 11-Year Median Follow-Up | OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with an 11-year median follow-up for OS events. | Years 3, 5, 7, 9, 10, 11, 12 |
| Percentage of Participants With Recurrence-Free Survival (RFS) Events Compared to Observation: 8-Year Median Follow-Up | RFS events included local, regional, or distant tumor recurrence. The percentage of participants with at least one RFS event was reported. | From Baseline until time of event (median of 8 years) |
| RFS Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up | RFS events included local, regional, or distant tumor recurrence. The percentage of participants free of RFS events (i.e., the RFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. | Years 3, 5, 7, 8 |
| Percentage of Participants With RFS Events in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up | RFS events included local, regional, or distant tumor recurrence. The percentage of participants with at least one RFS event was reported. | From Baseline until time of event (median of 8 years) |
| RFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up | RFS events included local, regional, or distant tumor recurrence. The percentage of participants free of RFS events (i.e., the RFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. | Years 3, 5, 7, 8 |
| Percentage of Participants With Distant Disease-Free Survival (DDFS) Events Compared to Observation: 8-Year Median Follow-Up | DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants with at least one DDFS event was reported. | From Baseline until time of event (median of 8 years) |
| DDFS Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up | DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants free of DDFS events (i.e., the DDFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. | Years 3, 5, 7, 8 |
| Percentage of Participants With DDFS Events in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up | DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants with at least one DDFS event was reported. | From Baseline until time of event (median of 8 years) |
| DDFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up | DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants free of DDFS events (i.e., the DDFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. | Years 3, 5, 7, 8 |
| Percentage of Participants With Tumor Recurrence (TR) Compared to Observation: 8-Year Median Follow-Up | The percentage of participants with TR of the present breast cancer was reported. TR included local, regional, or distant tumor ignoring contralateral breast cancer and second non-breast malignancy. | From Baseline until time of event (median of 8 years) |
| TR-Free Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up | The percentage of participants without TR of the present breast cancer (i.e., the TR-free rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. TR included local, regional, or distant tumor ignoring contralateral breast cancer and second non-breast malignancy. | Years 3, 5, 7, 8 |
| Percentage of Participants With TR in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up | The percentage of participants with TR of the present breast cancer was reported. TR included local, regional, or distant tumor ignoring contralateral breast cancer and second non-breast malignancy. | From Baseline until time of event (median of 8 years) |
| TR-Free Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up | The percentage of participants without TR of the present breast cancer (i.e., the TR-free rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. TR included local, regional, or distant tumor ignoring contralateral breast cancer and second non-breast malignancy. | Years 3, 5, 7, 8 |
| Percentage of Participants With Distant Tumor Recurrence (DTR) Compared to Observation: 8-Year Median Follow-Up | The percentage of participants with DTR was reported. DTR included distant tumors ignoring local and regional recurrences, contralateral breast cancer, and second non-breast malignancy. | From Baseline until time of event (median of 8 years) |
| DTR-Free Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up | The percentage of participants without DTR (i.e., the DTR-free rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. DTR included distant tumors ignoring local and regional recurrences, contralateral breast cancer, and second non-breast malignancy. | Years 3, 5, 7, 8 |
| Percentage of Participants With DTR in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up | The percentage of participants with DTR was reported. DTR included distant tumors ignoring local and regional recurrences, contralateral breast cancer, and second non-breast malignancy. | From Baseline until time of event (median of 8 years) |
| DTR-Free Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up | The percentage of participants without DTR (i.e., the DTR-free rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. DTR included distant tumors ignoring local and regional recurrences, contralateral breast cancer, and second non-breast malignancy. | Years 3, 5, 7, 8 |
| Percentage of Participants With Restricted Disease-Free Survival (RDFS) Events in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up | RDFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer, or death from any cause. The percentage of participants with at least one RDFS event was reported. | From Baseline until time of event (median of 8 years) |
| RDFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up | RDFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer, or death from any cause. The percentage of participants free of RDFS events (i.e., the RDFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. | Years 3, 5, 7, 8 |
| Percentage of Participants With Primary Cardiac Endpoint Events Compared to Observation: 10-Year Maximum Follow-Up | Primary cardiac endpoint events included the occurrence of any of the following between randomization and new therapy for recurrent disease: symptomatic New York Heart Association (NYHA) Class III or IV congestive heart failure (CHF) confirmed by a cardiologist with a drop in left ventricular ejection fraction (LVEF) at least 10 percentage points from Baseline and to a value less than (<) 50%, and documentation of definite or probable cardiac death. Definite cardiac death included CHF, myocardial infarction, or primary arrhythmia. Probable cardiac death included unexpected sudden death within 24 hours of a cardiac event (syncope, cardiac arrest, chest pain, infarction, arrhythmia) without documented etiology. The percentage of participants with at least one primary cardiac endpoint event was reported. The 95% CI was calculated by the Pearson-Clopper method for a one-sample binomial. | From Baseline until time of event (maximum up to 10 years) |
| Percentage of Participants With Secondary Cardiac Endpoint Events Compared to Observation: 10-Year Maximum Follow-Up | Secondary cardiac endpoint events included NYHA Class I or II CHF with a drop in LVEF measured by multiple-gated acquisition or electrocardiogram, unless the subsequent assessment of LVEF indicated a return to levels that did not meet the definition of a significant LVEF drop. A significant LVEF drop was defined as an absolute reduction of at least 10 percentage points from Baseline and to a value <50%. The percentage of participants with at least one secondary cardiac endpoint event was reported, excluding those with both a primary and secondary cardiac endpoint event. The 95% CI was calculated by the Pearson-Clopper method for a one-sample binomial. | From Baseline until time of event (maximum up to 10 years) |
| Geelong |
| Australian Capital Territory |
| 3220 |
| Australia |
| Toowoomba Hospital | Toowoomba | Queensland | 4350 | Australia |
| Andrew Love Cancer Centre | Geelong | Victoria | 3220 | Australia |
| Mount Hospital | Perth | Western Australia | 6000 | Australia |
| Landeskrankenhaus Feldkirch | Feldkirch-Tisis | 6807 | Austria |
| Innsbruck Universitaetsklinik | Innsbruck | A-6020 | Austria |
| Landeskrankenhaus Klagenfurt | Klagenfurt | 9026 | Austria |
| St. Vincent's Hospital | Linz Donau | A-4010 | Austria |
| Landeskrankenanstalten - Salzburg | Salzburg | A-5020 | Austria |
| Landeskrankenhaus St. Poelten | Sankt Pölten | 3100 | Austria |
| Universitaetsklinik fuer Innere Medizin I | Vienna | 1090 | Austria |
| Wilhelminenspital der Stadt Wien | Vienna | A-1160 | Austria |
| LKH Villach | Villach | 9500 | Austria |
| LKH Voecklabruck | Vöcklabruck | 4840 | Austria |
| A. oe. Krankenhaus Wiener Neustadt | Wiener Neustadt | A-2700 | Austria |
| Ziekenhuis Netwerk Antwerpen Middelheim | Antwerp | 2020 | Belgium |
| Reseau Hospitalier De Medecine Sociale | Baudour | 7331 | Belgium |
| Hopital Universitaire Erasme | Brussels | 1070 | Belgium |
| Academisch Ziekenhuis der Vrije Universiteit Brussel | Brussels | 1090 | Belgium |
| Institut Jules Bordet | Brussels | B-1000 | Belgium |
| Centre Hospitalier Notre Dame - Reine Fabiola | Charleroi | 6000 | Belgium |
| Cazk Groeninghe - Campus St-Niklaas | Kortrijk | B-8500 | Belgium |
| Centre Hospitalier Universitaire de Tivoli | La Louvière | 7100 | Belgium |
| U.Z. Gasthuisberg | Leuven | B-3000 | Belgium |
| Clinique Saint-Joseph | Liège | B 4000 | Belgium |
| CHU Liege - Domaine Universitaire du Sart Tilman | Liège | B-4000 | Belgium |
| Clinique Sainte Elisabeth | Namur | 5000 | Belgium |
| Hospital Serruys Ziekenhuis | Ostend | 8400 | Belgium |
| Centre Hospitalier Peltzer-La Tourelle | Verviers | B-4800 | Belgium |
| Porto Alegre Hospital | Porto Alegre | Rio Grande do Sul | 90035-003 | Brazil |
| Hospital Sao Lucas da PUCRS | Porto Alegre | 90610-000 | Brazil |
| Hospital Santa Rita | Porto Alegre | 91330-490 | Brazil |
| Instituto Nacional de Cancer | Rio de Janeiro | 20560-120 | Brazil |
| Faculdade De Medicina Do ABC | Santo André | 09060-650 | Brazil |
| Tom Baker Cancer Centre - Calgary | Calgary | Alberta | T2N 4N2 | Canada |
| British Columbia Cancer Agency - Centre for the Southern Interior | Kelowna | British Columbia | V1Y 5L3 | Canada |
| Fraser Valley Cancer Centre at British Columbia Cancer Agency | Surrey | British Columbia | V3V 1Z2 | Canada |
| British Columbia Cancer Agency - Vancouver Cancer Centre | Vancouver | British Columbia | V5Z 4E6 | Canada |
| British Columbia Cancer Agency - Vancouver Island Cancer Centre | Victoria | British Columbia | V8R 6V5 | Canada |
| CancerCare Manitoba | Winnipeg | Manitoba | R2H 2A6 | Canada |
| Royal Victoria Hospital of Barrie | Barrie | Ontario | L4M 6M2 | Canada |
| Margaret and Charles Juravinski Cancer Centre | Hamilton | Ontario | L8V 5C2 | Canada |
| Trillium Health Centre - Mississauga Site | Mississauga | Ontario | L5B 1B8 | Canada |
| Algoma Regional Cancer Program at Sault Area Hospital | Sault Ste. Marie | Ontario | P6A 2C4 | Canada |
| Hotel Dieu Health Sciences Hospital - Niagara | St. Catharines | Ontario | L2R 5K3 | Canada |
| Toronto East General Hospital | Toronto | Ontario | M4C 3E7 | Canada |
| Mount Sinai Hospital - Toronto | Toronto | Ontario | M5G 1X5 | Canada |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| Windsor Regional Cancer Centre at Windsor Regional Hospital | Windsor | Ontario | N8W 2X3 | Canada |
| Prince Edward Island Cancer Centre at Queen Elizabeth Hospital | Charlottetown | Prince Edward Island | C1A 8T5 | Canada |
| Hopital du Saint-Sacrement, Quebec | Québec | Quebec | G1S 4L8 | Canada |
| Allan Blair Cancer Centre at Pasqua Hospital | Regina | Saskatchewan | S4T 7T1 | Canada |
| Saskatoon Cancer Centre at the University of Saskatchewan | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| Fundacion Arturo Lopez Perez | Santiago | 29 | Chile |
| Hospital Clinico San Borja Arriaran | Santiago | Chile |
| Hospital Dr. Sotero Del Rio | Santiago | Chile |
| Hospital Militar | Santiago | Chile |
| Instituto Nacional Del Cancer | Santiago | Chile |
| Queen Mary Hospital | Hong Kong | China |
| Tuen Mun Hospital | Hong Kong | China |
| Tongji Medical University | Wuhan | 430030 | China |
| Instituto Nacional De Cancerologia | Bogotá | Colombia |
| Clinical Hospital Center Split | Split | 21000 | Croatia |
| Centralsygehus I Esbjerg | Esbjerg | 6700 | Denmark |
| Herning Central Hospital | Herning | 7400 | Denmark |
| Hillerod Hospital | Hillerød | 3400 | Denmark |
| Centralsygehuset I Naestved | Næstved | 4700 | Denmark |
| Sonderborg Sygehus | Sønderborg | 6400 | Denmark |
| Centre Regional Francois Baclesse | Caen | 14076 | France |
| Centre Hospital Regional Universitaire de Limoges | Limoges | 87042 | France |
| Hopital Clinique Claude Bernard | Metz | 57072 | France |
| Charite - Campus Charite Mitte | Berlin | D-10117 | Germany |
| Evangelisches Bethesda Krankenhaus GmbH | Essen | D-45355 | Germany |
| Universitaetsklinikum Freiburg | Freiburg im Breisgau | D-79106 | Germany |
| Martin Luther Universitaet | Halle | D-06097 | Germany |
| Henriettenstiftung Krankenhaus | Hanover | D-30559 | Germany |
| Universitaets-Hautklinik Heidelberg | Heidelberg | D-69115 | Germany |
| St. Vincentius-Kliniken | Karlsruhe | D-76137 | Germany |
| University Hospital Schleswig-Holstein - Kiel Campus | Kiel | D-24105 | Germany |
| Kreiskrankenhaus Leonberg - Frauenklinik | Leonberg | D-71229 | Germany |
| Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg | Magdeburg | D-39120 | Germany |
| Frauenklinik Vom Roten Kreuz | Munich | 80637 | Germany |
| Klinikum Rechts Der Isar - Technische Universitaet Muenchen | Munich | D-81675 | Germany |
| Frauenklinik - Universitaetsklinikum Rostock am Klinikum Sudstadt | Rostock | D-18059 | Germany |
| Universitaet Ulm | Ulm | D-89075 | Germany |
| Dr. Horst-Schmidt-Kliniken | Wiesbaden | D-65199 | Germany |
| University of Crete School of Medicine | Heraklion | Crete | 71110 | Greece |
| Evaggelismos Hospital | Athens | 10676 | Greece |
| Centro Medico | Guatemala City | 01010 | Guatemala |
| Hospital Roosevelt | Guatemala City | 01010 | Guatemala |
| Prince of Wales Hospital | Shatin, New Territories | Hong Kong |
| Semmelweis University | Budapest | 1082 | Hungary |
| National Institute of Oncology | Budapest | 1122 | Hungary |
| Fovarosi Onkormanyzat Szent Margit Korhaz, Okologia | Budapest | H-1032 | Hungary |
| Cork University Hospital | Cork | Ireland |
| Sieff Hospital | Safed | 13110 | Israel |
| Ospedale San Lazzaro | Alba | 12051 | Italy |
| Ospedale Presenti Fenaroli | Alzano Lombardo | 24022 | Italy |
| Centro di Riferimento Oncologico - Aviano | Aviano | 33081 | Italy |
| Ospedali Riuniti di Bergamo | Bergamo | 24100 | Italy |
| Ospedale degli Infermi - ASL 12 | Biella | 13900 | Italy |
| Ospedale Bellaria | Bologna | I-40139 | Italy |
| Spedali Civili di Brescia | Brescia | 25124 | Italy |
| Ospedale Oncologico A. Businco | Cagliari | 09100 | Italy |
| Ospedale B. Ramazzini | Carpi | 41012 | Italy |
| Ospedale Valduce | Como | 22100 | Italy |
| Ospedale Santa Croce | Cuneo | 12100 | Italy |
| Universita Degli Studi Di Florence | Firenze (Florence) | 50121 | Italy |
| Azienda Ospedaliero Careggi | Florence | 50139 | Italy |
| Morgagni-Pierantoni Ospedale | Forlì | 47100 | Italy |
| Istituto Nazionale per la Ricerca sul Cancro | Genoa | 16132 | Italy |
| Ospedale A. Manzoni | Lecco | 23900 | Italy |
| Presidio Ospedaliero | Livorno | 57100 | Italy |
| Carlo Poma Hospital | Mantua | 46100 | Italy |
| European Institute of Oncology | Milan | 20141 | Italy |
| Ospedale Niguarda Ca'Granda | Milan | 20162 | Italy |
| University of Modena Hospital and Reggio Emilia School of Medicine | Modena | 41100 | Italy |
| Azienda Ospedaliera Di Parma | Parma | 43100 | Italy |
| I.R.C.C.S. Policlinico San Matteo | Pavia | 27100 | Italy |
| Policlinico Monteluce | Perugia | 06122 | Italy |
| Azienda Ospedaliera | Reggio Emilia | 42100 | Italy |
| Ospedale San Filippo Neri | Rome | 00135 | Italy |
| Ospedale Sant' Eugenio | Rome | 00144 | Italy |
| Istituto Clinico Humanitas | Rozzano | 20089 | Italy |
| Ospedale Civile ASL 1 | Sassari | 07100 | Italy |
| Primario U.O. di Oncologia Medica | Trento | 38100 | Italy |
| Ospedale Ostetrico Ginecologica Sant Anna | Turin | 10126 | Italy |
| Universita di Torino | Turin | 10126 | Italy |
| Tokai University School Of Medicine | Kanagawa | 259-1193 | Japan |
| Tokyo Metropolitan - Komagome Hospital | Tokyo | 113-8677 | Japan |
| Academisch Ziekenhuis Maastricht | Maastricht | 6202 AZ | Netherlands |
| Maasland Hospital | Sittard | 6131 BK | Netherlands |
| Diakonessenhuis Utrecht | Utrecht | 3508 TG | Netherlands |
| Medical University of Gdansk | Gdansk | 80-211 | Poland |
| Oncologic Center | Gliwice | 44-101 | Poland |
| Medical University | Poznan | 61-878 | Poland |
| Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology | Warsaw | 02-781 | Poland |
| Instituto Portugues de Oncologia, Centro Regional de Coimbra | Coimbra | 3000-075 | Portugal |
| Hospitais da Universidade de Coimbra (HUC) | Coimbra | 3000 | Portugal |
| Maternidade Byssaia Barreto | Coimbra | 3000 | Portugal |
| Hospital Distrital De Faro | Faro | 8000 | Portugal |
| Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A. | Lisbon | 1099-023 Codex | Portugal |
| University Hospital of Santa Maria | Lisbon | 1649-035 | Portugal |
| Moscow Oncology Hospital | Moscow | 107005 | Russia |
| P.A. Hertzen Research Oncology Institute | Moscow | 125284 | Russia |
| Johns Hopkins Singapore International Medical Centre | Singapore | 308433 | Singapore |
| Groote Schuur Hospital | Cape Town | 7925 | South Africa |
| Parklands Hospital | Durban | 4001 | South Africa |
| Sandton Oncology Centre | Johannesburg | 2121 | South Africa |
| Medical Oncology Centre of Rosebank | Johannesburg | 2193 | South Africa |
| Pretoria - East Hospital | Lynnwood | 0081 | South Africa |
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| Yonsei Cancer Center at Yonsei University Medical Center | Seoul | 120-752 | South Korea |
| Centro Oncologico De Galicia Jose Antonio Quirogay Pineyro | A Coruña | 15009 | Spain |
| Hospital De La Ribera | Alzira | 46600 | Spain |
| Hospital Del Mar | Barcelona | 08003 | Spain |
| Hospital Universitario San Cecilio de Granada | Granada | 18003 | Spain |
| Hospital General Universitario De Guadalajara | Guadalajara | 19002 | Spain |
| Hospital Juan Ramon Jimenez | Huelva | 21005 | Spain |
| Hospital Cuidad de Jaen | Jaén | 23007 | Spain |
| Hospital Insular de Gran Canaria | Las Palmas | G.C. | Spain |
| Hospital de Gran Canaria Dr. Negrin | Las Palmas de Gran Canaria | 35020 | Spain |
| Hospital de la Princesa | Madrid | 28006 | Spain |
| Complejo Hospitalario Santa Maria | Ourense | 32005 | Spain |
| Complejo Hospitalario de Pontevedra | Pontevedra | 36001 | Spain |
| Consorci Hospitalari del Parc Tauli | Sabadell | 08208 | Spain |
| Hospital Universitario Canarias | San Cristóbal de La Laguna | 38320 | Spain |
| Hospital Universitario Nuestra Senora de la Candelaria | Santa Cruz de Tenerife | 38010 | Spain |
| Hospital Universidad Virgen Del Rocio | Seville | E- 41013 | Spain |
| Hospital Virgen Del La Salud | Toledo | 45004 | Spain |
| Hospital General Universitario Valencia | Valencia | 41014 | Spain |
| Complexo Hospitalario Xeral de Vigo | Vigo Pontevedra | 36204 | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | 59009 | Spain |
| University Hospital of Linkoping | Linköping | S-581 85 | Sweden |
| University Hospital of Malmoe | Malmö | 20502 | Sweden |
| Sahlgrenska University Hospital - Molndal at Gothenburg University | Mölndal | S-43180 | Sweden |
| Karolinska University Hospital - Huddinge | Stockholm | S-171 76 | Sweden |
| Umea Universitet | Umeå | SE-901 87 | Sweden |
| Uppsala University Hospital | Uppsala | SE-75185 | Sweden |
| Kantonspital Aarau | Aarau | 5001 | Switzerland |
| Universitaetsspital-Basel | Basel | CH-4031 | Switzerland |
| Inselspital Bern | Bern | CH-3010 | Switzerland |
| Spitaeler Chur AG | Chur | CH-7000 | Switzerland |
| Centre Hospitalier Universitaire Vaudois | Lausanne | CH-1011 | Switzerland |
| Ospedale Beata Vergine | Mendrisio | CH-6850 | Switzerland |
| Kantonsspital - St. Gallen | Sankt Gallen | CH-9007 | Switzerland |
| UniversitaetsSpital Zuerich | Zurich | CH-8091 | Switzerland |
| Chulalongkorn University Hospital | Bangkok | 10330 | Thailand |
| Ramathibodi Hospital | Bangkok | 10400 | Thailand |
| Bradford Hospitals NHS Trust | Bradford | England | BD9 6RJ | United Kingdom |
| Broomfield Hospital | Chelmsford, Essex | England | CM1 7ET | United Kingdom |
| Saint Margaret's Hospital | Epping Essex | England | CM16 6TN | United Kingdom |
| Diana Princess of Wales Hospital | Grimsby | England | DN33 2BA | United Kingdom |
| Huddersfield Royal Infirmary | Huddersfield, West Yorks | England | HD3 3EA | United Kingdom |
| Princess Royal Hospital | Hull | England | HU8 9HE | United Kingdom |
| Cookridge Hospital at Leeds Teaching Hospital NHS Trust | Leeds | England | LS16 6QB | United Kingdom |
| Imperial College of Medicine | London | England | W12 0NN | United Kingdom |
| James Cook University Hospital | Middlesbrough | England | TS4 3BW | United Kingdom |
| Northern Centre for Cancer Treatment at Newcastle General Hospital | Newcastle upon Tyne | England | NE4 6BE | United Kingdom |
| Cancer Research Centre at Weston Park Hospital | Sheffield | England | S1O 2SJ | United Kingdom |
| Airedale General Hospital | West Yorkshire | England | BD20 6TD | United Kingdom |
| Southend NHS Trust Hospital | Westcliff-on-Sea | England | SS0 0RY | United Kingdom |
| 21354370 | Result | Gianni L, Dafni U, Gelber RD, Azambuja E, Muehlbauer S, Goldhirsch A, Untch M, Smith I, Baselga J, Jackisch C, Cameron D, Mano M, Pedrini JL, Veronesi A, Mendiola C, Pluzanska A, Semiglazov V, Vrdoljak E, Eckart MJ, Shen Z, Skiadopoulos G, Procter M, Pritchard KI, Piccart-Gebhart MJ, Bell R; Herceptin Adjuvant (HERA) Trial Study Team. Treatment with trastuzumab for 1 year after adjuvant chemotherapy in patients with HER2-positive early breast cancer: a 4-year follow-up of a randomised controlled trial. Lancet Oncol. 2011 Mar;12(3):236-44. doi: 10.1016/S1470-2045(11)70033-X. Epub 2011 Feb 25. |
| 20530280 | Result | Procter M, Suter TM, de Azambuja E, Dafni U, van Dooren V, Muehlbauer S, Climent MA, Rechberger E, Liu WT, Toi M, Coombes RC, Dodwell D, Pagani O, Madrid J, Hall M, Chen SC, Focan C, Muschol M, van Veldhuisen DJ, Piccart-Gebhart MJ. Longer-term assessment of trastuzumab-related cardiac adverse events in the Herceptin Adjuvant (HERA) trial. J Clin Oncol. 2010 Jul 20;28(21):3422-8. doi: 10.1200/JCO.2009.26.0463. Epub 2010 Jun 7. |
| 19364966 | Result | Dowsett M, Procter M, McCaskill-Stevens W, de Azambuja E, Dafni U, Rueschoff J, Jordan B, Dolci S, Abramovitz M, Stoss O, Viale G, Gelber RD, Piccart-Gebhart M, Leyland-Jones B. Disease-free survival according to degree of HER2 amplification for patients treated with adjuvant chemotherapy with or without 1 year of trastuzumab: the HERA Trial. J Clin Oncol. 2009 Jun 20;27(18):2962-9. doi: 10.1200/JCO.2008.19.7939. Epub 2009 Apr 13. |
| 18296421 | Result | Untch M, Gelber RD, Jackisch C, Procter M, Baselga J, Bell R, Cameron D, Bari M, Smith I, Leyland-Jones B, de Azambuja E, Wermuth P, Khasanov R, Feng-Yi F, Constantin C, Mayordomo JI, Su CH, Yu SY, Lluch A, Senkus-Konefka E, Price C, Haslbauer F, Suarez Sahui T, Srimuninnimit V, Colleoni M, Coates AS, Piccart-Gebhart MJ, Goldhirsch A; HERA Study Team. Estimating the magnitude of trastuzumab effects within patient subgroups in the HERA trial. Ann Oncol. 2008 Jun;19(6):1090-6. doi: 10.1093/annonc/mdn005. Epub 2008 Feb 21. |
| Result | McCaskill-Stevens W, Procter M, Goodbrand J, et al.: Disease-free survival according to local immunohistochemistry for HER2 and central fluorescence in situ hydridization for patients treated with adjuvant chemotherapy with and without trastuzumab in the HERA (BIG 01-01) trial. [Abstract] Breast Cancer Res Treat 106 (1): A-71, S18, 2007. |
| 17208639 | Result | Smith I, Procter M, Gelber RD, Guillaume S, Feyereislova A, Dowsett M, Goldhirsch A, Untch M, Mariani G, Baselga J, Kaufmann M, Cameron D, Bell R, Bergh J, Coleman R, Wardley A, Harbeck N, Lopez RI, Mallmann P, Gelmon K, Wilcken N, Wist E, Sanchez Rovira P, Piccart-Gebhart MJ; HERA study team. 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial. Lancet. 2007 Jan 6;369(9555):29-36. doi: 10.1016/S0140-6736(07)60028-2. |
| 17646669 | Result | Suter TM, Procter M, van Veldhuisen DJ, Muscholl M, Bergh J, Carlomagno C, Perren T, Passalacqua R, Bighin C, Klijn JG, Ageev FT, Hitre E, Groetz J, Iwata H, Knap M, Gnant M, Muehlbauer S, Spence A, Gelber RD, Piccart-Gebhart MJ. Trastuzumab-associated cardiac adverse effects in the herceptin adjuvant trial. J Clin Oncol. 2007 Sep 1;25(25):3859-65. doi: 10.1200/JCO.2006.09.1611. Epub 2007 Jul 23. |
| 16236737 | Result | Piccart-Gebhart MJ, Procter M, Leyland-Jones B, Goldhirsch A, Untch M, Smith I, Gianni L, Baselga J, Bell R, Jackisch C, Cameron D, Dowsett M, Barrios CH, Steger G, Huang CS, Andersson M, Inbar M, Lichinitser M, Lang I, Nitz U, Iwata H, Thomssen C, Lohrisch C, Suter TM, Ruschoff J, Suto T, Greatorex V, Ward C, Straehle C, McFadden E, Dolci MS, Gelber RD; Herceptin Adjuvant (HERA) Trial Study Team. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005 Oct 20;353(16):1659-72. doi: 10.1056/NEJMoa052306. |
| 41671466 | Derived | Bae SJ, Moon S, Kook Y, Baek SH, Lee M, Jeong J, Ahn SG. Ovarian Function Suppression in HR-Positive, HER2-Positive Breast Cancer: An Exploratory Analysis of the HERA Trial. J Natl Compr Canc Netw. 2025 Dec;23(12):539-547. doi: 10.6004/jnccn.2025.7080. |
| 40175431 | Derived | Bae SJ, Moon S, Kook Y, Baek SH, Lee M, Kim JH, Ahn SG, Jeong J. Clinical relevance of clinical treatment score post-5 years (CTS5) in HR-positive, HER2-positive breast cancer. NPJ Breast Cancer. 2025 Apr 2;11(1):33. doi: 10.1038/s41523-025-00747-6. |
| 28379421 | Derived | Yerushalmi R, Dong B, Chapman JW, Goss PE, Pollak MN, Burnell MJ, Levine MN, Bramwell VHC, Pritchard KI, Whelan TJ, Ingle JN, Shepherd LE, Parulekar WR, Han L, Ding K, Gelmon KA. Impact of baseline BMI and weight change in CCTG adjuvant breast cancer trials. Ann Oncol. 2017 Jul 1;28(7):1560-1568. doi: 10.1093/annonc/mdx152. |
| 28215665 | Derived | Cameron D, Piccart-Gebhart MJ, Gelber RD, Procter M, Goldhirsch A, de Azambuja E, Castro G Jr, Untch M, Smith I, Gianni L, Baselga J, Al-Sakaff N, Lauer S, McFadden E, Leyland-Jones B, Bell R, Dowsett M, Jackisch C; Herceptin Adjuvant (HERA) Trial Study Team. 11 years' follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive early breast cancer: final analysis of the HERceptin Adjuvant (HERA) trial. Lancet. 2017 Mar 25;389(10075):1195-1205. doi: 10.1016/S0140-6736(16)32616-2. Epub 2017 Feb 17. |
| 27100299 | Derived | Loi S, Dafni U, Karlis D, Polydoropoulou V, Young BM, Willis S, Long B, de Azambuja E, Sotiriou C, Viale G, Ruschoff J, Piccart MJ, Dowsett M, Michiels S, Leyland-Jones B. Effects of Estrogen Receptor and Human Epidermal Growth Factor Receptor-2 Levels on the Efficacy of Trastuzumab: A Secondary Analysis of the HERA Trial. JAMA Oncol. 2016 Aug 1;2(8):1040-7. doi: 10.1001/jamaoncol.2016.0339. |
| 26101239 | Derived | O'Sullivan CC, Bradbury I, Campbell C, Spielmann M, Perez EA, Joensuu H, Costantino JP, Delaloge S, Rastogi P, Zardavas D, Ballman KV, Holmes E, de Azambuja E, Piccart-Gebhart M, Zujewski JA, Gelber RD. Efficacy of Adjuvant Trastuzumab for Patients With Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer and Tumors </= 2 cm: A Meta-Analysis of the Randomized Trastuzumab Trials. J Clin Oncol. 2015 Aug 20;33(24):2600-8. doi: 10.1200/JCO.2015.60.8620. Epub 2015 Jun 22. |
| 24912899 | Derived | de Azambuja E, Procter MJ, van Veldhuisen DJ, Agbor-Tarh D, Metzger-Filho O, Steinseifer J, Untch M, Smith IE, Gianni L, Baselga J, Jackisch C, Cameron DA, Bell R, Leyland-Jones B, Dowsett M, Gelber RD, Piccart-Gebhart MJ, Suter TM. Trastuzumab-associated cardiac events at 8 years of median follow-up in the Herceptin Adjuvant trial (BIG 1-01). J Clin Oncol. 2014 Jul 10;32(20):2159-65. doi: 10.1200/JCO.2013.53.9288. Epub 2014 Jun 9. |
| 23894039 | Derived | Zabaglo L, Stoss O, Ruschoff J, Zielinski D, Salter J, Arfi M, Bradbury I, Dafni U, Piccart-Gebhart M, Procter M, Dowsett M; HERA Trial Study Team. HER2 staining intensity in HER2-positive disease: relationship with FISH amplification and clinical outcome in the HERA trial of adjuvant trastuzumab. Ann Oncol. 2013 Nov;24(11):2761-6. doi: 10.1093/annonc/mdt275. Epub 2013 Jul 25. |
| 23871490 | Derived | Goldhirsch A, Gelber RD, Piccart-Gebhart MJ, de Azambuja E, Procter M, Suter TM, Jackisch C, Cameron D, Weber HA, Heinzmann D, Dal Lago L, McFadden E, Dowsett M, Untch M, Gianni L, Bell R, Kohne CH, Vindevoghel A, Andersson M, Brunt AM, Otero-Reyes D, Song S, Smith I, Leyland-Jones B, Baselga J; Herceptin Adjuvant (HERA) Trial Study Team. 2 years versus 1 year of adjuvant trastuzumab for HER2-positive breast cancer (HERA): an open-label, randomised controlled trial. Lancet. 2013 Sep 21;382(9897):1021-8. doi: 10.1016/S0140-6736(13)61094-6. Epub 2013 Jul 18. |
| 23589556 | Derived | Metzger-Filho O, Procter M, de Azambuja E, Leyland-Jones B, Gelber RD, Dowsett M, Loi S, Saini KS, Cameron D, Untch M, Smith I, Gianni L, Baselga J, Jackisch C, Bell R, Sotiriou C, Viale G, Piccart-Gebhart M. Magnitude of trastuzumab benefit in patients with HER2-positive, invasive lobular breast carcinoma: results from the HERA trial. J Clin Oncol. 2013 Jun 1;31(16):1954-60. doi: 10.1200/JCO.2012.46.2440. Epub 2013 Apr 15. |
| Herceptin 1-Year Arm |
Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. |
| FG002 | Herceptin 2-Year Arm | Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. |
| Crossover to Adjuvant Herceptin |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full Analysis Set (FAS) Population: All enrolled/randomized participants who had an available signed Informed Consent Form.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Observation Arm | Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided. |
| BG001 | Herceptin 1-Year Arm | Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. |
| BG002 | Herceptin 2-Year Arm | Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Disease-Free Survival (DFS) Events in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an Independent Data Monitoring Committee (IDMC) in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure. | FAS Population. The "Number of Participants Analyzed" reflects the number with data for the endpoint. | Posted | Number | percentage of participants | From Baseline until time of event (median of 1 year) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With DFS Events in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure. | FAS Population. The "Number of Participants Analyzed" reflects the number with data for the endpoint. | Posted | Number | percentage of participants | From Baseline until time of event (median of 1 year) |
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| Primary | DFS Rate According to Kaplan-Meier Analysis in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95 percent (%) confidence interval (CI) were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an IDMC in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure. | FAS Population. The "Number of Participants Analyzed" reflects the number with data for the endpoint. | Posted | Number | 95% Confidence Interval | percentage of participants | Year 2 |
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| Primary | DFS Rate According to Kaplan-Meier Analysis in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure. | FAS Population. The "Number of Participants Analyzed" reflects the number with data for the endpoint. | Posted | Number | 95% Confidence Interval | percentage of participants | Year 2 |
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| Primary | Percentage of Participants With DFS Events Compared to Observation: 8-Year Median Follow-Up | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported. | FAS Population | Posted | Number | percentage of participants | From Baseline until time of event (median of 8 years) |
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| Primary | DFS Rate at Year 3 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. | FAS Population | Posted | Number | 95% Confidence Interval | percentage of participants | Year 3 |
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| Primary | DFS Rate at Year 5 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. | FAS Population | Posted | Number | 95% Confidence Interval | percentage of participants | Year 5 |
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| Primary | DFS Rate at Year 7 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. | FAS Population | Posted | Number | 95% Confidence Interval | percentage of participants | Year 7 |
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| Primary | DFS Rate at Year 8 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. | FAS Population | Posted | Number | 95% Confidence Interval | percentage of participants | Year 8 |
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| Primary | Percentage of Participants With DFS Events Compared to Observation: 10-Year Maximum Follow-Up | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported. | FAS Population | Posted | Number | percentage of participants | From Baseline until time of event (maximum of 10 years) |
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| Primary | DFS Rate at Year 3 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events. | FAS Population | Posted | Number | 95% Confidence Interval | percentage of participants | Year 3 |
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| Primary | DFS Rate at Year 5 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events. | FAS Population | Posted | Number | 95% Confidence Interval | percentage of participants | Year 5 |
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| Primary | DFS Rate at Year 7 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events. | FAS Population | Posted | Number | 95% Confidence Interval | percentage of participants | Year 7 |
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| Primary | DFS Rate at Year 8 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events. | FAS Population | Posted | Number | 95% Confidence Interval | percentage of participants | Year 8 |
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| Primary | DFS Rate at Year 9 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events. | FAS Population | Posted | Number | 95% Confidence Interval | percentage of participants | Year 9 |
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| Primary | DFS Rate at Year 10 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events. | FAS Population | Posted | Number | 95% Confidence Interval | percentage of participants | Year 10 |
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| Secondary | Percentage of Participants With DFS Events in 1-Year Versus 2-Year Herceptin: 10-Year Maximum Follow-Up | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported. | FAS Population 1-Year Herceptin Versus 2-Year Herceptin (1Y2Y): Participants without a DFS event and still under follow-up at the pre-defined landmark of 366 days after randomization, analyzed when intent-to-treat principle was applied for comparison of 1 year versus 2 years of Herceptin. | Posted | Number | percentage of participants | From Baseline until time of event (maximum of 10 years) |
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| Secondary | DFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 10-Year Maximum Follow-Up | DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events. | FAS Population 1Y2Y | Posted | Number | 95% Confidence Interval | percentage of participants | Years 3, 5, 7, 8, 9, 10 |
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| Secondary | Percentage of Participants With Overall Survival (OS) Events in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up | OS events referred to death from any cause. The percentage of participants who died was reported. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an IDMC in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure. | FAS Population. The "Number of Participants Analyzed" reflects the number with data for the endpoint. | Posted | Number | percentage of participants | From Baseline until time of event (median of 1 year) |
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| Secondary | Percentage of Participants With OS Events in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up | OS events referred to death from any cause. The percentage of participants who died was reported. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure. | FAS Population. The "Number of Participants Analyzed" reflects the number with data for the endpoint. | Posted | Number | percentage of participants | From Baseline until time of event (median of 1 year) |
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| Secondary | OS Rate According to Kaplan-Meier Analysis in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up | OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an IDMC in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure. | FAS Population. The "Number of Participants Analyzed" reflects the number with data for the endpoint. | Posted | Number | 95% Confidence Interval | percentage of participants | Year 2 |
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| Secondary | OS Rate According to Kaplan-Meier Analysis in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up | OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure. | FAS Population. The "Number of Participants Analyzed" reflects the number with data for the endpoint. | Posted | Number | 95% Confidence Interval | percentage of participants | Year 2 |
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| Secondary | Percentage of Participants With OS Events Compared to Observation: 8-Year Median Follow-Up | OS events referred to death from any cause. The percentage of participants who died was reported. | FAS Population | Posted | Number | percentage of participants | From Baseline until time of event (median of 8 years) |
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| Secondary | OS Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up | OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. | FAS Population | Posted | Number | 95% Confidence Interval | percentage of participants | Years 3, 5, 7, 8 |
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| Secondary | Percentage of Participants With OS Events Compared to Observation: 11-Year Median Follow-Up | OS events referred to death from any cause. The percentage of participants who died was reported. | FAS Population | Posted | Number | percentage of participants | From Baseline until time of event (median of 11 years) |
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| Secondary | OS Rate According to Kaplan-Meier Analysis Compared to Observation: 11-Year Median Follow-Up | OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with an 11-year median follow-up for OS events. | FAS Population | Posted | Number | 95% Confidence Interval | percentage of participants | Years 3, 5, 7, 9, 10, 11, 12 |
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| Secondary | Percentage of Participants With OS Events in 1-Year Versus 2-Year Herceptin: 11-Year Median Follow-Up | OS events referred to death from any cause. The percentage of participants who died was reported. | FAS Population 1Y2Y | Posted | Number | percentage of participants | From Baseline until time of event (median of 11 years) |
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| Secondary | OS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 11-Year Median Follow-Up | OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with an 11-year median follow-up for OS events. | FAS Population 1Y2Y | Posted | Number | 95% Confidence Interval | percentage of participants | Years 3, 5, 7, 9, 10, 11, 12 |
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| Secondary | Percentage of Participants With Recurrence-Free Survival (RFS) Events Compared to Observation: 8-Year Median Follow-Up | RFS events included local, regional, or distant tumor recurrence. The percentage of participants with at least one RFS event was reported. | FAS Population | Posted | Number | percentage of participants | From Baseline until time of event (median of 8 years) |
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| Secondary | RFS Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up | RFS events included local, regional, or distant tumor recurrence. The percentage of participants free of RFS events (i.e., the RFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. | FAS Population | Posted | Number | 95% Confidence Interval | percentage of participants | Years 3, 5, 7, 8 |
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| Secondary | Percentage of Participants With RFS Events in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up | RFS events included local, regional, or distant tumor recurrence. The percentage of participants with at least one RFS event was reported. | FAS Population 1Y2Y | Posted | Number | percentage of participants | From Baseline until time of event (median of 8 years) |
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| Secondary | RFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up | RFS events included local, regional, or distant tumor recurrence. The percentage of participants free of RFS events (i.e., the RFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. | FAS Population 1Y2Y | Posted | Number | 95% Confidence Interval | percentage of participants | Years 3, 5, 7, 8 |
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| Secondary | Percentage of Participants With Distant Disease-Free Survival (DDFS) Events Compared to Observation: 8-Year Median Follow-Up | DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants with at least one DDFS event was reported. | FAS Population | Posted | Number | percentage of participants | From Baseline until time of event (median of 8 years) |
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| Secondary | DDFS Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up | DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants free of DDFS events (i.e., the DDFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. | FAS Population | Posted | Number | 95% Confidence Interval | percentage of participants | Years 3, 5, 7, 8 |
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| Secondary | Percentage of Participants With DDFS Events in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up | DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants with at least one DDFS event was reported. | FAS Population 1Y2Y | Posted | Number | percentage of participants | From Baseline until time of event (median of 8 years) |
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| Secondary | DDFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up | DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants free of DDFS events (i.e., the DDFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. | FAS Population 1Y2Y | Posted | Number | 95% Confidence Interval | percentage of participants | Years 3, 5, 7, 8 |
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| Secondary | Percentage of Participants With Tumor Recurrence (TR) Compared to Observation: 8-Year Median Follow-Up | The percentage of participants with TR of the present breast cancer was reported. TR included local, regional, or distant tumor ignoring contralateral breast cancer and second non-breast malignancy. | FAS Population | Posted | Number | percentage of participants | From Baseline until time of event (median of 8 years) |
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| Secondary | TR-Free Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up | The percentage of participants without TR of the present breast cancer (i.e., the TR-free rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. TR included local, regional, or distant tumor ignoring contralateral breast cancer and second non-breast malignancy. | FAS Population | Posted | Number | 95% Confidence Interval | percentage of participants | Years 3, 5, 7, 8 |
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| Secondary | Percentage of Participants With TR in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up | The percentage of participants with TR of the present breast cancer was reported. TR included local, regional, or distant tumor ignoring contralateral breast cancer and second non-breast malignancy. | FAS Population 1Y2Y | Posted | Number | percentage of participants | From Baseline until time of event (median of 8 years) |
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| Secondary | TR-Free Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up | The percentage of participants without TR of the present breast cancer (i.e., the TR-free rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. TR included local, regional, or distant tumor ignoring contralateral breast cancer and second non-breast malignancy. | FAS Population 1Y2Y | Posted | Number | 95% Confidence Interval | percentage of participants | Years 3, 5, 7, 8 |
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| Secondary | Percentage of Participants With Distant Tumor Recurrence (DTR) Compared to Observation: 8-Year Median Follow-Up | The percentage of participants with DTR was reported. DTR included distant tumors ignoring local and regional recurrences, contralateral breast cancer, and second non-breast malignancy. | FAS Population | Posted | Number | percentage of participants | From Baseline until time of event (median of 8 years) |
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| Secondary | DTR-Free Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up | The percentage of participants without DTR (i.e., the DTR-free rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. DTR included distant tumors ignoring local and regional recurrences, contralateral breast cancer, and second non-breast malignancy. | FAS Population | Posted | Number | 95% Confidence Interval | percentage of participants | Years 3, 5, 7, 8 |
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| Secondary | Percentage of Participants With DTR in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up | The percentage of participants with DTR was reported. DTR included distant tumors ignoring local and regional recurrences, contralateral breast cancer, and second non-breast malignancy. | FAS Population 1Y2Y | Posted | Number | percentage of participants | From Baseline until time of event (median of 8 years) |
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| Secondary | DTR-Free Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up | The percentage of participants without DTR (i.e., the DTR-free rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. DTR included distant tumors ignoring local and regional recurrences, contralateral breast cancer, and second non-breast malignancy. | FAS Population 1Y2Y | Posted | Number | 95% Confidence Interval | percentage of participants | Years 3, 5, 7, 8 |
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| Secondary | Percentage of Participants With Restricted Disease-Free Survival (RDFS) Events in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up | RDFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer, or death from any cause. The percentage of participants with at least one RDFS event was reported. | FAS Population 1Y2Y. In contrast to other study endpoints, RDFS compared to the Observation Arm was not a planned endpoint according to study protocol. Only RDFS in Herceptin 1-Year Arm versus Herceptin 2-Year Arm was a planned endpoint. | Posted | Number | percentage of participants | From Baseline until time of event (median of 8 years) |
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| Secondary | RDFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up | RDFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer, or death from any cause. The percentage of participants free of RDFS events (i.e., the RDFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. | FAS Population 1Y2Y. In contrast to other study endpoints, RDFS compared to the Observation Arm was not a planned endpoint according to study protocol. Only RDFS in Herceptin 1-Year Arm versus Herceptin 2-Year Arm was a planned endpoint. | Posted | Number | 95% Confidence Interval | percentage of participants | Years 3, 5, 7, 8 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Primary Cardiac Endpoint Events Compared to Observation: 10-Year Maximum Follow-Up | Primary cardiac endpoint events included the occurrence of any of the following between randomization and new therapy for recurrent disease: symptomatic New York Heart Association (NYHA) Class III or IV congestive heart failure (CHF) confirmed by a cardiologist with a drop in left ventricular ejection fraction (LVEF) at least 10 percentage points from Baseline and to a value less than (<) 50%, and documentation of definite or probable cardiac death. Definite cardiac death included CHF, myocardial infarction, or primary arrhythmia. Probable cardiac death included unexpected sudden death within 24 hours of a cardiac event (syncope, cardiac arrest, chest pain, infarction, arrhythmia) without documented etiology. The percentage of participants with at least one primary cardiac endpoint event was reported. The 95% CI was calculated by the Pearson-Clopper method for a one-sample binomial. | Safety Population: All participants randomized/enrolled in the study according to actual treatment received. Hence, participants assigned to Herceptin who received no study treatment were analyzed in the Observation Arm. | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline until time of event (maximum up to 10 years) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Secondary Cardiac Endpoint Events Compared to Observation: 10-Year Maximum Follow-Up | Secondary cardiac endpoint events included NYHA Class I or II CHF with a drop in LVEF measured by multiple-gated acquisition or electrocardiogram, unless the subsequent assessment of LVEF indicated a return to levels that did not meet the definition of a significant LVEF drop. A significant LVEF drop was defined as an absolute reduction of at least 10 percentage points from Baseline and to a value <50%. The percentage of participants with at least one secondary cardiac endpoint event was reported, excluding those with both a primary and secondary cardiac endpoint event. The 95% CI was calculated by the Pearson-Clopper method for a one-sample binomial. | Safety Population | Posted | Number | 95% Confidence Interval | percentage of participants | From Baseline until time of event (maximum up to 10 years) |
|
From Baseline until end of treatment (maximum up to 2 years) with the exception of cardiac/cardiovascular events, second primary malignancies, pregnancies, and Herceptin-related adverse events (maximum up to 10 years)
Analysis Population Description: Safety Population
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Observation Arm | Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided. After the release of initial study results, participants in the Observation Arm were allowed to cross over to receive adjuvant Herceptin prior to disease recurrence. As such, adverse events that occurred after crossover were not included in the safety analyses for this arm. | 143 | 1,744 | 1,076 | 1,744 | ||
| EG001 | Herceptin 1-Year Arm | Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. | 269 | 1,682 | 1,389 | 1,682 | ||
| EG002 | Herceptin 2-Year Arm | Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. | 344 | 1,673 | 1,440 | 1,673 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Extrasystoles | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypertensive heart disease | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pericarditis lupus | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dermoid cyst | Congenital, familial and genetic disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Odontogenic cyst | Congenital, familial and genetic disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Tooth hypoplasia | Congenital, familial and genetic disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Ventricular septal defect | Congenital, familial and genetic disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Otosclerosis | Ear and labyrinth disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Basedow's disease | Endocrine disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Eyelid ptosis | Eye disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Paraesthesia oral | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Breast complication associated with device | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Catheter site haemorrhage | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Device breakage | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Device dislocation | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Device failure | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Device leakage | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Fat necrosis | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Granuloma | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Ill-defined disorder | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Local swelling | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Medical device complication | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Medical device pain | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Mucosal haemorrhage | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Multi-organ disorder | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Sudden death | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hepatitis toxic | Hepatobiliary disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Bartholin's abscess | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Breast abscess | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Breast cellulitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Catheter site cellulitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Endometritis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Extradural abscess | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Genital infection female | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hepatitis B | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Labyrinthitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Lymphangitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Mastitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Muscle abscess | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Parotitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pulmonary mycosis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Rectal abscess | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Salmonellosis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Salpingo-oophoritis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Spinal cord abscess | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Streptococcal sepsis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Acetabulum fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Fractured coccyx | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Nerve injury | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pneumothorax traumatic | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Post-traumatic neck syndrome | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Postoperative hernia | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pubis fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pulmonary contusion | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Scar | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Spinal column injury | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Wound secretion | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Tendon disorder | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Adenocarcinoma pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Adenoid cystic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Adenoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Adenosquamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Angiosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Benign breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Benign neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Benign neoplasm of bladder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Benign neoplasm of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Benign ovarian tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Bladder papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Breast cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Carcinoid tumour of the gastrointestinal tract | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cervix carcinoma stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cervix carcinoma stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Colorectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Endometrial adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Fibroadenoma of breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Gastric adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Gastrointestinal stromal tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Infected neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Inflammatory myofibroblastic tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Invasive papillary breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Lipofibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Mantle cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Metastatic renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Oesophageal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Ovarian adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Paget's disease of nipple | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Rectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Retro-orbital neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Second primary malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Squamous cell carcinoma of the vulva | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Undifferentiated sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Uterine leiomyosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Vulval cancer stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Central nervous system haemorrhage | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cerebellar atrophy | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dementia Alzheimer's type | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Myoclonus | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Nystagmus | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Optic neuritis | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Paresis | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Abortion missed | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
| |
| Complication of pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
| |
| Delivery | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
| |
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
| |
| Alcohol abuse | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Delusion | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Adnexa uteri mass | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Breast calcifications | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Breast disorder | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Breast dysplasia | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Breast fibrosis | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Breast haematoma | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Breast hyperplasia | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Breast inflammation | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Breast mass | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Breast necrosis | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cervical polyp | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Fibrocystic breast disease | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Genital prolapse | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Nipple exudate bloody | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Rectocele | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Uterine polyp | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Vocal cord polyp | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Prurigo | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Scar pain | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Telangiectasia | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Mammoplasty | Surgical and medical procedures | MedDRA (18.0) | Non-systematic Assessment |
| |
| Nerve block | Surgical and medical procedures | MedDRA (18.0) | Non-systematic Assessment |
| |
| Aortic occlusion | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Microangiopathy | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Subclavian vein thrombosis | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Vaginal prolapse | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Onychoclasis | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | global-roche-genentech-trials@gene.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| 0.54 |
| 2-Sided |
| 95 |
| 0.44 |
| 0.67 |
HR for Herceptin 1-Year Arm versus Observation Arm. |
| Superiority or Other |
|
|
|
Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. |
|
|
Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
|
|
| OG002 |
| Herceptin 2-Year Arm |
Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. |
|
|
|
| OG002 | Herceptin 2-Year Arm | Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. |
|
|
| OG002 | Herceptin 2-Year Arm | Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. |
|
|
| OG002 | Herceptin 2-Year Arm | Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. |
|
|
| OG002 | Herceptin 2-Year Arm | Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. |
|
|
| OG002 |
| Herceptin 2-Year Arm |
Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. |
|
|
|
| OG002 | Herceptin 2-Year Arm | Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. |
|
|
| OG002 | Herceptin 2-Year Arm | Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. |
|
|
| OG002 | Herceptin 2-Year Arm | Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. |
|
|
| OG002 | Herceptin 2-Year Arm | Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. |
|
|
| OG002 | Herceptin 2-Year Arm | Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. |
|
|
| OG002 | Herceptin 2-Year Arm | Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. |
|
|
|
|
|
| Herceptin 2-Year Arm |
Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
|
|
|
| Herceptin 2-Year Arm |
Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. |
|
|
|
|
|
|
|
Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. |
|
|
|
| Herceptin 2-Year Arm |
Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. |
|
|
|
|
|
|
|
Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. |
|
|
|
| OG002 |
| Herceptin 2-Year Arm |
Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. |
|
|
|
|
|
|
|
Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. |
|
|
|
| OG002 |
| Herceptin 2-Year Arm |
Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. |
|
|
|
|
|
|
|
|
|
|
|
|
| OG001 | Herceptin 1-Year Arm | Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. |
| OG002 | Herceptin 2-Year Arm | Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. |
|
|
| OG002 | Herceptin 2-Year Arm | Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. |
|
|