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The study is being terminated due to no enrollment in over one year in the control arm
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The purpose of this study was to compare the efficacy of immediate single-stage post-mastectomy breast reconstruction with Strattice Reconstructive Tissue Matrix (Strattice) as compared to immediate two-stage post-mastectomy breast reconstruction where the initially placed expander was exchanged for a breast implant only, without any type of reinforcement.
The primary objective of this study is to compare the efficacy of immediate single-stage post-mastectomy breast reconstruction with Strattice™ TM, otherwise referred to as DTI as compared to immediate two-stage post-mastectomy breast reconstruction where the initially placed expander will be exchanged for a breast implant only, without any type of a reinforcement. The objective will be achieved by prospectively assessing the number of planned and unplanned post-mastectomy surgical interventions within 12 months of the mastectomy.
Two-stage breast reconstruction will include the initial placement of a tissue expander in a total or partial submuscular position. In the case of partial muscle coverage, this will be without the support of any mesh or autologous flap to reinforce the lower pole. The expander will be inflated over approximately the next one to six months, and then replaced with an implant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast Reconstruction, Direct to Implant (DTI) with Strattice™ | Active Comparator | Participants underwent immediate post-mastectomy breast reconstruction with a breast implant and Strattice™ reconstructive tissue matrix (surgical mesh). |
|
| Two Stage Breast Reconstruction | Active Comparator | Participants underwent immediate, two-stage post-mastectomy breast reconstruction without reinforcement. Initial placement of a tissue expander that was inflated for approximately one to six months, and then replaced with an implant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breast Reconstruction, Direct to Implant (DTI) with Strattice™ | Procedure |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of Planned and Unplanned Post-mastectomy Surgical Interventions Per Participant on the Reconstructed Breast, Within 12 Months of the Initial Study Surgery (ISS) | ISS was defined as the DTI breast reconstruction with Strattice™ or the first surgery of the two-stage breast reconstruction. Data is presented for participants with unilateral (one breast) and bilateral (two breast) reconstruction. Postmastectomy surgical interventions on the reconstructed breast were reported for each participant and the total number of planned and unplanned post-mastectomy surgical interventions was averaged in each group. | Up to 12 months post ISS |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing One or More Serious Breast Reconstruction-related Complications (BRRC) | Serious BRRC were complications that required re-entry of the breast pocket with or without exchange or removal of the implant and any manipulation of the implant pocket including the infra-mammary fold (IMF). Serious BRRC were detected through review by a medical monitor. Surgical complications included: capsular contracture (Baker grade ≥ 3), infection (local or systemic), hematoma, seroma, inflammation, skin or flap necrosis, implant extrusion, malposition, malrotation, asymmetry, bottoming out. |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related Quality of Life | At 3, 6, and 12 months post-mastectomy and at 4 months ppR | |
| Healthcare Resource Use Including Length of Hospital Stay and Clinic Visits | At 6 and 12 months post-mastectomy and at 24 months ppR |
Inclusion Criteria:
Exclusion Criteria:
Single Stage Breast Reconstruction in Female Participants with Mastectomy
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| Name | Affiliation | Role |
|---|---|---|
| Donna Jacobs | Allergan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonie | Bordeaux | 33076 | France | |||
| Centre Oscar Lambret |
Out of the 131 enrolled participants, 127 received the study device and were included in the Safety population.
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Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Breast Reconstruction, Direct to Implant (DTI) With Strattice™ | Participants underwent immediate post-mastectomy breast reconstruction with a breast implant and Strattice™ reconstructive tissue matrix (surgical mesh). |
| FG001 | Two Stage Breast Reconstruction |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Two Stage Breast Reconstruction |
| Procedure |
|
| Up to 12 months post ISS |
| Number of Participants Experiencing One or More Serious BRRC Within 24 Months of Post-Permanent Reconstruction (ppR) | Serious BRRC were complications that required re-entry of the breast pocket with or without exchange or removal of the implant and any manipulation of the implant pocket including the IMF. Serious BRRC were detected through review by a medical monitor. BRRC were defined as: a) infection, local or systemic, b) hematoma, c) seroma, d) inflammation, e) skin or flap necrosis, f) capsular contraction as defined by Baker grade > 3, g) implant extrusion (loss or explants), and h) malposition, malrotation, asymmetry, and bottoming out. | Up to 24 months ppR |
| Number of Participants With Clinically Significant Cases of Capsular Contracture as Defined by Baker Grade III or IV Within 24 Months of ppR | The surgeon assessed the level of capsular contracture in the participant's breast using the Baker Breast Contracture Scale where: Grade I=breast is normally soft and looks natural, Grade II=breast is a little firm but looks normal, Grade III=breast is firm and looks abnormal and Grade IV= breast is hard, painful, and looks abnormal. Baker Grade III and IV were defined as clinically significant and are reported here. Data is presented for number of participants with capsular contracture per breast (right breast and left breast). | Up to 24 months ppR |
| Aesthetic Outcomes of Participants Using Blinded Assessment 2D Photographs by Independent Review Panel | Baseline up to Month 24 |
| Number of Planned and Unplanned Post-mastectomy Surgical Interventions of the Reconstructed Breast Within 6 Months of ISS | ISS was defined as the DTI breast reconstruction with Strattice™ or the first surgery of the two-stage breast reconstruction. Data is presented for participants with unilateral (one breast) and bilateral (two breast) reconstruction. Postmastectomy surgical interventions on the reconstructed breast were reported for each participant and the total number of planned and unplanned post-mastectomy surgical interventions was averaged in each group. | Baseline up to 6 months post ISS |
| Number of Planned and Unplanned Post-mastectomy Surgical Interventions of the Reconstructed Breast | Surgical interventions were all planned and unplanned post-mastectomy surgical interventions per participant on the reconstructed breast, within 24 months of the ISS, which is defined as the DTI breast reconstruction with Strattice™ TM or the first surgery of the two-stage breast reconstruction. Data is presented for participants with unilateral (one breast) and bilateral (two breast) reconstruction. | Within 24 months ppR |
| Time to Return to Work or Normal Daily Activities | 6 and 12 months post-mastectomy and 24 month ppR |
| Lille |
| 59000 |
| France |
| Institut du Cancer de Montpellier Val d'Aurelle | Montpellier | 34298 | France |
| L'Institut du Sein- Paris Breast Center | Paris | 75116 | France |
| Hopital Tenon APHP | Paris | France |
| Universitätsklinikum Erlangen | Erlangen | 91054 | Germany |
| Kliniken Essen-Mitte | Essen | 45131 | Germany |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Universitäts-Frauenklinik Heidelberg | Heidelberg | 69115 | Germany |
| Klinik der Universität München, Campus Innenstadt | Munich | 80337 | Germany |
| Klinikum rechts der Isar | Munich | 81675 | Germany |
| Asklepios Paulinen Klinik | Wiesbaden | 65197 | Germany |
| St Luke's hospital / Bradford Royal Infirmary (BRI) | Bradford | BD5 0NA | United Kingdom |
| Dorset County Hospital | Dorchester | DT1 2JY | United Kingdom |
| Frimley Park Hospital | Frimley | GU16 7UJ | United Kingdom |
| Wythenshawe Hospital UHSM NHS Foundation Trust | Manchester | M23 9LT | United Kingdom |
| City Hospital | Nottingham | NG5 1PB | United Kingdom |
Participants underwent immediate, two-stage post-mastectomy breast reconstruction without reinforcement. Initial placement of a tissue expander that was inflated for approximately one to six months, and then replaced with an implant. |
| Safety Set |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety set included all participants who underwent a mastectomy followed by one of the two implant-based breast reconstruction methods and had their first surgery date recorded.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Breast Reconstruction, Direct to Implant (DTI) With Strattice™ | Participants underwent immediate post-mastectomy breast reconstruction with a breast implant and Strattice™ reconstructive tissue matrix (surgical mesh). |
| BG001 | Two Stage Breast Reconstruction | Participants underwent immediate, two-stage post-mastectomy breast reconstruction without reinforcement. Initial placement of a tissue expander that was inflated for approximately one to six months, and then replaced with an implant. |
| BG002 | 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | 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 | Mean Number of Planned and Unplanned Post-mastectomy Surgical Interventions Per Participant on the Reconstructed Breast, Within 12 Months of the Initial Study Surgery (ISS) | ISS was defined as the DTI breast reconstruction with Strattice™ or the first surgery of the two-stage breast reconstruction. Data is presented for participants with unilateral (one breast) and bilateral (two breast) reconstruction. Postmastectomy surgical interventions on the reconstructed breast were reported for each participant and the total number of planned and unplanned post-mastectomy surgical interventions was averaged in each group. | Post-ISS analysis set consisted of all participants who underwent a mastectomy and completed their first reconstruction surgery post-mastectomy and have a valid surgical assessment at least 337 days post ISS (12 month [365 days]-4 week [28 days] window). Number analyzed is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | interventions per participant | Up to 12 months post ISS |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing One or More Serious Breast Reconstruction-related Complications (BRRC) | Serious BRRC were complications that required re-entry of the breast pocket with or without exchange or removal of the implant and any manipulation of the implant pocket including the infra-mammary fold (IMF). Serious BRRC were detected through review by a medical monitor. Surgical complications included: capsular contracture (Baker grade ≥ 3), infection (local or systemic), hematoma, seroma, inflammation, skin or flap necrosis, implant extrusion, malposition, malrotation, asymmetry, bottoming out. | Post-ISS analysis set consisted of all participants who underwent a mastectomy followed by one of the two implant-based breast reconstruction methods and completed their first reconstruction surgery post-mastectomy and have a valid surgical assessment at least 337 days post ISS (12 month [365 days]-4 week [28 days] window). | Posted | Count of Participants | Participants | Up to 12 months post ISS |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing One or More Serious BRRC Within 24 Months of Post-Permanent Reconstruction (ppR) | Serious BRRC were complications that required re-entry of the breast pocket with or without exchange or removal of the implant and any manipulation of the implant pocket including the IMF. Serious BRRC were detected through review by a medical monitor. BRRC were defined as: a) infection, local or systemic, b) hematoma, c) seroma, d) inflammation, e) skin or flap necrosis, f) capsular contraction as defined by Baker grade > 3, g) implant extrusion (loss or explants), and h) malposition, malrotation, asymmetry, and bottoming out. | ppR Follow-up set consisted of all participants who underwent a mastectomy followed by one of the two implant-based breast reconstruction methods and completed the 24 months ppR visit. Participants whose 24-month visit was performed early due to termination of the study were also included. | Posted | Count of Participants | Participants | Up to 24 months ppR |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Cases of Capsular Contracture as Defined by Baker Grade III or IV Within 24 Months of ppR | The surgeon assessed the level of capsular contracture in the participant's breast using the Baker Breast Contracture Scale where: Grade I=breast is normally soft and looks natural, Grade II=breast is a little firm but looks normal, Grade III=breast is firm and looks abnormal and Grade IV= breast is hard, painful, and looks abnormal. Baker Grade III and IV were defined as clinically significant and are reported here. Data is presented for number of participants with capsular contracture per breast (right breast and left breast). | Safety set included all participants who underwent a mastectomy followed by one of the two implant-based breast reconstruction methods and had their first surgery date recorded. Number analyzed for each category includes those participants for whom the Baker grade was assessed. | Posted | Number | participants | Up to 24 months ppR |
| |||||||||||||||||||||||||||||||
| Secondary | Aesthetic Outcomes of Participants Using Blinded Assessment 2D Photographs by Independent Review Panel | The independent reviewer panel was not established and data were not collected due to early termination of the study, hence this endpoint could not be analyzed. | Posted | Baseline up to Month 24 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Planned and Unplanned Post-mastectomy Surgical Interventions of the Reconstructed Breast Within 6 Months of ISS | ISS was defined as the DTI breast reconstruction with Strattice™ or the first surgery of the two-stage breast reconstruction. Data is presented for participants with unilateral (one breast) and bilateral (two breast) reconstruction. Postmastectomy surgical interventions on the reconstructed breast were reported for each participant and the total number of planned and unplanned post-mastectomy surgical interventions was averaged in each group. | Safety set included all participants who underwent a mastectomy followed by one of the two implant-based breast reconstruction methods and had their first surgery date recorded. Number analyzed is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | interventions per participant | Baseline up to 6 months post ISS |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Planned and Unplanned Post-mastectomy Surgical Interventions of the Reconstructed Breast | Surgical interventions were all planned and unplanned post-mastectomy surgical interventions per participant on the reconstructed breast, within 24 months of the ISS, which is defined as the DTI breast reconstruction with Strattice™ TM or the first surgery of the two-stage breast reconstruction. Data is presented for participants with unilateral (one breast) and bilateral (two breast) reconstruction. | ppR Follow-up set included all participants who underwent a mastectomy followed by one of the two implant-based breast reconstruction methods and completed 24 months ppR visit; whose 24-month visit was performed early due to termination of study were also included. Number analyzed is number of participants with data available at given time-point. | Posted | Mean | Standard Deviation | interventions per participant | Within 24 months ppR |
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Health-related Quality of Life | Not Posted | At 3, 6, and 12 months post-mastectomy and at 4 months ppR | Participants | |||||||||||||||||||||||||||||||||||
| Other Pre-specified | Healthcare Resource Use Including Length of Hospital Stay and Clinic Visits | Not Posted | At 6 and 12 months post-mastectomy and at 24 months ppR | Participants | |||||||||||||||||||||||||||||||||||
| Other Pre-specified | Time to Return to Work or Normal Daily Activities | Not Posted | 6 and 12 months post-mastectomy and 24 month ppR | Participants |
From the first day post-surgery up to 24 months for participants enrolled in the Breast Reconstruction, DTI arm and approximately 25-30 months for participants enrolled in the Two-stage Reconstruction arm.
The number of participants at risk for Serious Adverse Events and Other Adverse Events is based on the Safety Set. 4 participants did not have first surgery date and were not included in Safety Set.
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 | Breast Reconstruction, Direct to Implant (DTI) With Strattice™ | Participants underwent immediate post-mastectomy breast reconstruction with a breast implant and Strattice™ reconstructive tissue matrix (surgical mesh). | 0 | 76 | 49 | 76 | 53 | 76 |
| EG001 | Two Stage Breast Reconstruction | Participants underwent immediate, two-stage post-mastectomy breast reconstruction without reinforcement. Initial placement of a tissue expander that was inflated for approximately one to six months, and then replaced with an implant. | 0 | 55 | 27 | 51 | 35 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin necrosis | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Anisomastia | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Capsular contracture associated with breast implant | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Mastoptosis | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Red breast syndrome | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Biopsy lymph gland abnormal | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Invasive breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Adenocarcinoma of the cervix | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Neoplasm recurrence | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Ovarian fibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Breast cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Fat tissue decreased | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Medical device discomfort | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Chondrocalcinosis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Febrile bone marrow aplasia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Device extrusion | Product Issues | MedDRA 20.0 | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA 20.0 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 20.0 | Systematic Assessment |
| |
| Delivery | Pregnancy, puerperium and perinatal conditions | MedDRA 20.0 | Systematic Assessment |
| |
| Salpingo-oophorectomy | Surgical and medical procedures | MedDRA 20.0 | Systematic Assessment |
| |
| Salpingo-oophorectomy bilateral | Surgical and medical procedures | MedDRA 20.0 | Systematic Assessment |
| |
| Breast operation | Surgical and medical procedures | MedDRA 20.0 | Systematic Assessment |
| |
| Mammoplasty | Surgical and medical procedures | MedDRA 20.0 | Systematic Assessment |
| |
| Breast reconstruction | Surgical and medical procedures | MedDRA 20.0 | Systematic Assessment |
| |
| Medical device removal | Surgical and medical procedures | MedDRA 20.0 | Systematic Assessment |
| |
| Ischaemia | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Suture related complication | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Device deployment issue | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Skin scar contracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Skin flap necrosis | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Scar | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Wound necrosis | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Mastitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Breast cellulitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Capsular contracture associated with breast implant | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Breast inflammation | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA 20.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Wound secretion | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Post procedural swelling | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Mastitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area, Head | Allergan | 714-246-4500 | clinicaltrials@allergan.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 |
|---|---|
| D016462 | Mammaplasty |
| D056324 | Diffusion Tensor Imaging |
| ID | Term |
|---|---|
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D019651 | Plastic Surgery Procedures |
| D013514 | Surgical Procedures, Operative |
| D059906 | Neuroimaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D038524 | Diffusion Magnetic Resonance Imaging |
| D008279 | Magnetic Resonance Imaging |
| D014054 | Tomography |
| D003943 | Diagnostic Techniques, Neurological |
| D008919 | Investigative Techniques |
Not provided
Not provided
| Male |
|
| Caucasian |
|
| Other |
|
| Missing |
|
| Non-Hispanic or non-Latino |
|
| Missing |
|
| Bilateral |
|
|
|
|
|
|
|
|
|
|
|
|