Trial Outcomes & Findings for Efficacy Study of Single Stage Breast Reconstruction in Female Participants With Mastectomy (NCT NCT01910298)

NCT ID: NCT01910298

Last Updated: 2019-12-04

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

131 participants

Primary outcome timeframe

Up to 12 months post ISS

Results posted on

2019-12-04

Participant Flow

Out of the 131 enrolled participants, 127 received the study device and were included in the Safety population.

Participant milestones

Participant milestones
Measure	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).	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.
Overall Study STARTED	76	55
Overall Study Safety Set	76	51
Overall Study COMPLETED	71	23
Overall Study NOT COMPLETED	5	32

Reasons for withdrawal

Reasons for withdrawal
Measure	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).	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.
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	2	7
Overall Study Protocol Deviation	0	5
Overall Study Lost to Follow-up	1	1
Overall Study Study Terminated by Sponsor	1	17
Overall Study Other Miscellaneous Reasons	0	2

Baseline Characteristics

Efficacy Study of Single Stage Breast Reconstruction in Female Participants With Mastectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Breast Reconstruction, Direct to Implant (DTI) With Strattice™ n=76 Participants Participants underwent immediate post-mastectomy breast reconstruction with a breast implant and Strattice™ reconstructive tissue matrix (surgical mesh).	Two Stage Breast Reconstruction n=51 Participants 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.	Total n=127 Participants Total of all reporting groups
Age, Continuous	46.8 years STANDARD_DEVIATION 10.58 • n=5 Participants	49.5 years STANDARD_DEVIATION 10.40 • n=7 Participants	47.9 years STANDARD_DEVIATION 10.56 • n=5 Participants
Sex: Female, Male Female	76 Participants n=5 Participants	51 Participants n=7 Participants	127 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Black/African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	51 Participants n=5 Participants	35 Participants n=7 Participants	86 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Missing	22 Participants n=5 Participants	16 Participants n=7 Participants	38 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic or non-Latino	53 Participants n=5 Participants	34 Participants n=7 Participants	87 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 months post ISS

Population: 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.

Outcome measures

Outcome measures
Measure	Breast Reconstruction, Direct to Implant (DTI) With Strattice™ n=69 Participants Participants underwent immediate post-mastectomy breast reconstruction with a breast implant and Strattice™ reconstructive tissue matrix (surgical mesh).	Two Stage Breast Reconstruction n=40 Participants 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.
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) Unilateral	1.6 interventions per participant Standard Deviation 1.87	2.2 interventions per participant Standard Deviation 1.91
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) Bilateral	1.2 interventions per participant Standard Deviation 1.99	2.3 interventions per participant Standard Deviation 1.10

SECONDARY outcome

Timeframe: Up to 12 months post ISS

Population: 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).

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.

Outcome measures

Outcome measures
Measure	Breast Reconstruction, Direct to Implant (DTI) With Strattice™ n=69 Participants Participants underwent immediate post-mastectomy breast reconstruction with a breast implant and Strattice™ reconstructive tissue matrix (surgical mesh).	Two Stage Breast Reconstruction n=40 Participants 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.
Number of Participants Experiencing One or More Serious Breast Reconstruction-related Complications (BRRC)	15 Participants	8 Participants

SECONDARY outcome

Timeframe: Up to 24 months ppR

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Breast Reconstruction, Direct to Implant (DTI) With Strattice™ n=72 Participants Participants underwent immediate post-mastectomy breast reconstruction with a breast implant and Strattice™ reconstructive tissue matrix (surgical mesh).	Two Stage Breast Reconstruction n=40 Participants 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.
Number of Participants Experiencing One or More Serious BRRC Within 24 Months of Post-Permanent Reconstruction (ppR)	19 Participants	9 Participants

SECONDARY outcome

Timeframe: Up to 24 months ppR

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Breast Reconstruction, Direct to Implant (DTI) With Strattice™ n=76 Participants Participants underwent immediate post-mastectomy breast reconstruction with a breast implant and Strattice™ reconstructive tissue matrix (surgical mesh).	Two Stage Breast Reconstruction n=51 Participants 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.
Number of Participants With Clinically Significant Cases of Capsular Contracture as Defined by Baker Grade III or IV Within 24 Months of ppR Right breast (Grade III)	0 participants	0 participants
Number of Participants With Clinically Significant Cases of Capsular Contracture as Defined by Baker Grade III or IV Within 24 Months of ppR Right breast (Grade IV)	0 participants	0 participants
Number of Participants With Clinically Significant Cases of Capsular Contracture as Defined by Baker Grade III or IV Within 24 Months of ppR Left Breast (Grade III)	1 participants	0 participants
Number of Participants With Clinically Significant Cases of Capsular Contracture as Defined by Baker Grade III or IV Within 24 Months of ppR Left Breast (Grade IV)	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline up to Month 24

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to 6 months post ISS

Population: 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.

Outcome measures

Outcome measures
Measure	Breast Reconstruction, Direct to Implant (DTI) With Strattice™ n=76 Participants Participants underwent immediate post-mastectomy breast reconstruction with a breast implant and Strattice™ reconstructive tissue matrix (surgical mesh).	Two Stage Breast Reconstruction n=51 Participants 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.
Number of Planned and Unplanned Post-mastectomy Surgical Interventions of the Reconstructed Breast Within 6 Months of ISS Bilateral	1.0 interventions per participant Standard Deviation 1.76	0.9 interventions per participant Standard Deviation 1.28
Number of Planned and Unplanned Post-mastectomy Surgical Interventions of the Reconstructed Breast Within 6 Months of ISS Unilateral	1.1 interventions per participant Standard Deviation 1.43	1.4 interventions per participant Standard Deviation 1.40

SECONDARY outcome

Timeframe: Within 24 months ppR

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Breast Reconstruction, Direct to Implant (DTI) With Strattice™ n=72 Participants Participants underwent immediate post-mastectomy breast reconstruction with a breast implant and Strattice™ reconstructive tissue matrix (surgical mesh).	Two Stage Breast Reconstruction n=40 Participants 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.
Number of Planned and Unplanned Post-mastectomy Surgical Interventions of the Reconstructed Breast Unilateral	2.1 interventions per participant Standard Deviation 2.04	3.0 interventions per participant Standard Deviation 2.60
Number of Planned and Unplanned Post-mastectomy Surgical Interventions of the Reconstructed Breast Bilateral	1.6 interventions per participant Standard Deviation 2.42	2.8 interventions per participant Standard Deviation 1.29

OTHER_PRE_SPECIFIED outcome

Timeframe: At 3, 6, and 12 months post-mastectomy and at 4 months ppR

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At 6 and 12 months post-mastectomy and at 24 months ppR

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 and 12 months post-mastectomy and 24 month ppR

Outcome measures

Outcome data not reported

Adverse Events

Breast Reconstruction, Direct to Implant (DTI) With Strattice™

Serious events: 49 serious events

Other events: 53 other events

Deaths: 0 deaths

Two Stage Breast Reconstruction

Serious events: 27 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Therapeutic Area, Head

Allergan

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Breast Reconstruction, Direct to Implant (DTI) With Strattice™ n=76 participants at risk Participants underwent immediate post-mastectomy breast reconstruction with a breast implant and Strattice™ reconstructive tissue matrix (surgical mesh).	Two Stage Breast Reconstruction n=51 participants at risk 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.
Skin and subcutaneous tissue disorders Erythema	13.2% 10/76 • 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.	15.7% 8/51 • 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.
Reproductive system and breast disorders Breast pain	5.3% 4/76 • 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.	11.8% 6/51 • 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.
Reproductive system and breast disorders Capsular contracture associated with breast implant	5.3% 4/76 • 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.	5.9% 3/51 • 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.
Reproductive system and breast disorders Breast inflammation	1.3% 1/76 • 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.	5.9% 3/51 • 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.
General disorders Pyrexia	1.3% 1/76 • 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.	5.9% 3/51 • 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.
General disorders Fatigue	1.3% 1/76 • 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.	7.8% 4/51 • 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.
General disorders Impaired healing	6.6% 5/76 • 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.	2.0% 1/51 • 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.
General disorders Asthenia	0.00% 0/76 • 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.	5.9% 3/51 • 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.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/76 • 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.	5.9% 3/51 • 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.
Musculoskeletal and connective tissue disorders Arthralgia	5.3% 4/76 • 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.	7.8% 4/51 • 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.
Gastrointestinal disorders Nausea	5.3% 4/76 • 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.	11.8% 6/51 • 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.
Immune system disorders Drug hypersensitivity	5.3% 4/76 • 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.	3.9% 2/51 • 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.
Product Issues Device dislocation	0.00% 0/76 • 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.	5.9% 3/51 • 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.
Vascular disorders Hot flush	5.3% 4/76 • 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.	9.8% 5/51 • 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.
Nervous system disorders Neuropathy peripheral	1.3% 1/76 • 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.	5.9% 3/51 • 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.
Injury, poisoning and procedural complications Seroma	34.2% 26/76 • 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.	25.5% 13/51 • 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.
Injury, poisoning and procedural complications Post procedural haematoma	6.6% 5/76 • 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.	25.5% 13/51 • 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.
Injury, poisoning and procedural complications Wound secretion	6.6% 5/76 • 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.	2.0% 1/51 • 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.
Injury, poisoning and procedural complications Procedural pain	7.9% 6/76 • 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.	23.5% 12/51 • 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.
Injury, poisoning and procedural complications Wound dehiscence	5.3% 4/76 • 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.	0.00% 0/51 • 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.
Injury, poisoning and procedural complications Post procedural swelling	0.00% 0/76 • 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.	9.8% 5/51 • 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.
Infections and infestations Mastitis	7.9% 6/76 • 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.	2.0% 1/51 • 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.