Trial Outcomes & Findings for Extension Study to Provide Adjuvant Treatment Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03 (NCT NCT04109391)
NCT ID: NCT04109391
Last Updated: 2022-10-26
Results Overview
Samples for the evaluation of anti-drug antibodies (ADA), including neutralizing antibodies (Nab) were obtained before the administration of Cycle 1 (Week 0), Cycle 6 (Week 15), and the EOT/ET Visit. Only subjects with a positive ADA result were further tested for ADA cross-reactivity and Nab. Only subjects with a positive Nab result were further tested for Nab cross-reactivity.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
338 participants
Primary outcome timeframe
Assessed from first infusion through end of treatment (Week 45) or Early Termination visit. Each cycle is 3 weeks.
Results posted on
2022-10-26
Participant Flow
Participant milestones
| Measure |
Test Product (TX05 Only)
IV trastuzumab (TX05) 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles
TX05 (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment.
These subjects received TX05 on the TX05-03 study and continued to receive TX05 in this extension study.
|
Reference Therapy (Herceptin Only)
IV trastuzumab (Herceptin) TX05 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles
Herceptin (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment.
These subjects received Herceptin on the TX05-03 study and continued to receive Herceptin in this extension study.
|
Test Product (Herceptin/TX05 Transition)
IV trastuzumab (TX05) 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles
TX05 (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment.
These subjects received Herceptin on the TX05-03 study and were randomized to receive TX05 in this extension study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
175
|
82
|
81
|
|
Overall Study
COMPLETED
|
165
|
77
|
77
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
4
|
Reasons for withdrawal
| Measure |
Test Product (TX05 Only)
IV trastuzumab (TX05) 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles
TX05 (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment.
These subjects received TX05 on the TX05-03 study and continued to receive TX05 in this extension study.
|
Reference Therapy (Herceptin Only)
IV trastuzumab (Herceptin) TX05 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles
Herceptin (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment.
These subjects received Herceptin on the TX05-03 study and continued to receive Herceptin in this extension study.
|
Test Product (Herceptin/TX05 Transition)
IV trastuzumab (TX05) 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles
TX05 (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment.
These subjects received Herceptin on the TX05-03 study and were randomized to receive TX05 in this extension study.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
|
Overall Study
Pregnancy
|
1
|
0
|
0
|
|
Overall Study
Subject refused to continue, AE and 2 patients only received 10 of 13 cycles
|
3
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
2
|
3
|
Baseline Characteristics
Extension Study to Provide Adjuvant Treatment Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03
Baseline characteristics by cohort
| Measure |
Test Product (TX05 Only)
n=175 Participants
IV trastuzumab (TX05) 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles
TX05 (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment.
These subjects received TX05 on the TX05-03 study and continued to receive TX05 in this extension study.
|
Reference Therapy (Herceptin Only)
n=82 Participants
IV trastuzumab (Herceptin) TX05 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles
Herceptin (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment.
These subjects received Herceptin on the TX05-03 study and continued to receive Herceptin in this extension study.
|
Test Product (Herceptin/TX05 Transition)
n=81 Participants
IV trastuzumab (TX05) 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles
TX05 (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment.
These subjects received Herceptin on the TX05-03 study and were randomized to receive TX05 in this extension study.
|
Total
n=338 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.3 years
STANDARD_DEVIATION 11.43 • n=99 Participants
|
53.7 years
STANDARD_DEVIATION 10.12 • n=107 Participants
|
54.0 years
STANDARD_DEVIATION 10.71 • n=206 Participants
|
54.6 years
STANDARD_DEVIATION 10.95 • n=7 Participants
|
|
Sex: Female, Male
Female
|
175 Participants
n=99 Participants
|
82 Participants
n=107 Participants
|
81 Participants
n=206 Participants
|
338 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
51 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
146 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
287 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
23 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
53 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
136 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
257 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
|
Hormone Receptor Status
Positive
|
100 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
198 Participants
n=7 Participants
|
|
Hormone Receptor Status
Negative
|
75 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
140 Participants
n=7 Participants
|
|
Tumor Stage
Stage IIa
|
65 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
125 Participants
n=7 Participants
|
|
Tumor Stage
Stage IIb
|
78 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
154 Participants
n=7 Participants
|
|
Tumor Stage
Stage IIIa
|
32 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
59 Participants
n=7 Participants
|
|
ECOG
Grade 0
|
142 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
262 Participants
n=7 Participants
|
|
ECOG
Grade 1
|
29 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
69 Participants
n=7 Participants
|
|
ECOG
Grade 2
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
ECOG
Grade 3
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
ECOG
Grade 4
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
ECOG
Grade 5
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
ECOG
Missing
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Assessed from first infusion through end of treatment (Week 45) or Early Termination visit. Each cycle is 3 weeks.Samples for the evaluation of anti-drug antibodies (ADA), including neutralizing antibodies (Nab) were obtained before the administration of Cycle 1 (Week 0), Cycle 6 (Week 15), and the EOT/ET Visit. Only subjects with a positive ADA result were further tested for ADA cross-reactivity and Nab. Only subjects with a positive Nab result were further tested for Nab cross-reactivity.
Outcome measures
| Measure |
Test Product (TX05 Only)
n=175 Participants
IV trastuzumab (TX05) 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles
TX05 (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment.
These subjects received TX05 on the TX05-03 study and continued to receive TX05 in this extension study.
|
Reference Therapy (Herceptin Only)
n=82 Participants
IV trastuzumab (Herceptin) TX05 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles
Herceptin (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment.
These subjects received Herceptin on the TX05-03 study and continued to receive Herceptin in this extension study.
|
Test Product (Herceptin/TX05 Transition)
n=81 Participants
IV trastuzumab (TX05) 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles
TX05 (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment.
These subjects received Herceptin on the TX05-03 study and were randomized to receive TX05 in this extension study.
|
|---|---|---|---|
|
Immunogenicity Assessments (ADA and Nab)
Baseline · ADA Positive
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Immunogenicity Assessments (ADA and Nab)
Baseline · Nab Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Immunogenicity Assessments (ADA and Nab)
Baseline · ADA Negative
|
159 Participants
|
77 Participants
|
74 Participants
|
|
Immunogenicity Assessments (ADA and Nab)
Baseline · Not evaluated
|
13 Participants
|
3 Participants
|
4 Participants
|
|
Immunogenicity Assessments (ADA and Nab)
Cycle 6 Week 15 · ADA Positive
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Immunogenicity Assessments (ADA and Nab)
End of Study/Early Terminiation · Nab Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Immunogenicity Assessments (ADA and Nab)
Cycle 6 Week 15 · Nab Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Immunogenicity Assessments (ADA and Nab)
Cycle 6 Week 15 · ADA Negative
|
164 Participants
|
74 Participants
|
74 Participants
|
|
Immunogenicity Assessments (ADA and Nab)
Cycle 6 Week 15 · Not evaluated
|
10 Participants
|
7 Participants
|
3 Participants
|
|
Immunogenicity Assessments (ADA and Nab)
End of Study/Early Terminiation · ADA Positive
|
4 Participants
|
1 Participants
|
2 Participants
|
|
Immunogenicity Assessments (ADA and Nab)
End of Study/Early Terminiation · ADA Negative
|
146 Participants
|
75 Participants
|
71 Participants
|
|
Immunogenicity Assessments (ADA and Nab)
End of Study/Early Terminiation · Not evaluated
|
25 Participants
|
6 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Through study completion/end of treatment (Week 45).DFS, defined as the time from randomization in the neoadjuvant study (Protocol TX05-03) to the documentation of a first failure, where a failure was the recurrence of breast cancer or a diagnosis of a second primary cancer.
Outcome measures
| Measure |
Test Product (TX05 Only)
n=175 Participants
IV trastuzumab (TX05) 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles
TX05 (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment.
These subjects received TX05 on the TX05-03 study and continued to receive TX05 in this extension study.
|
Reference Therapy (Herceptin Only)
n=82 Participants
IV trastuzumab (Herceptin) TX05 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles
Herceptin (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment.
These subjects received Herceptin on the TX05-03 study and continued to receive Herceptin in this extension study.
|
Test Product (Herceptin/TX05 Transition)
n=81 Participants
IV trastuzumab (TX05) 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles
TX05 (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment.
These subjects received Herceptin on the TX05-03 study and were randomized to receive TX05 in this extension study.
|
|---|---|---|---|
|
Disease-Free Survival
Discontinued form Study
|
8 Participants
|
4 Participants
|
2 Participants
|
|
Disease-Free Survival
Recurrence of Breast Cancer or a Diagnosis of a Second Primary Cancer
|
6 Participants
|
5 Participants
|
3 Participants
|
|
Disease-Free Survival
No recurrence of Breast Cancer and No Diagnosis of a Second Primary Cancer
|
160 Participants
|
73 Participants
|
76 Participants
|
|
Disease-Free Survival
No Post Baseline or No Evaluable Post Baseline
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Disease-Free Survival
No Baseline or No Evaluable Baseline Assessment
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Disease-Free Survival
Death
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Through study completion/end of treatment (Week 45).OS, defined as the time from randomization in the neoadjuvant study (Protocol TX05-03) until death from any cause.
Outcome measures
| Measure |
Test Product (TX05 Only)
n=175 Participants
IV trastuzumab (TX05) 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles
TX05 (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment.
These subjects received TX05 on the TX05-03 study and continued to receive TX05 in this extension study.
|
Reference Therapy (Herceptin Only)
n=82 Participants
IV trastuzumab (Herceptin) TX05 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles
Herceptin (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment.
These subjects received Herceptin on the TX05-03 study and continued to receive Herceptin in this extension study.
|
Test Product (Herceptin/TX05 Transition)
n=81 Participants
IV trastuzumab (TX05) 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles
TX05 (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment.
These subjects received Herceptin on the TX05-03 study and were randomized to receive TX05 in this extension study.
|
|---|---|---|---|
|
Overall Survival
Last known alive
|
175 Participants
|
82 Participants
|
80 Participants
|
|
Overall Survival
Lost to Follow-Up
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Overall Survival
Death
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Test Product (TX05 Only)
Serious events: 4 serious events
Other events: 49 other events
Deaths: 0 deaths
Reference Therapy (Herceptin Only)
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Test Product (Herceptin/TX05 Transition)
Serious events: 2 serious events
Other events: 15 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Test Product (TX05 Only)
n=175 participants at risk
IV trastuzumab (TX05) 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles
TX05 (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment.
These subjects received TX05 on the TX05-03 study and continued to receive TX05 in this extension study.
|
Reference Therapy (Herceptin Only)
n=82 participants at risk
IV trastuzumab (Herceptin) TX05 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles
Herceptin (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment.
These subjects received Herceptin on the TX05-03 study and continued to receive Herceptin in this extension study.
|
Test Product (Herceptin/TX05 Transition)
n=81 participants at risk
IV trastuzumab (TX05) 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles
TX05 (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment.
These subjects received Herceptin on the TX05-03 study and were randomized to receive TX05 in this extension study.
|
|---|---|---|---|
|
Infections and infestations
COVID-19
|
1.1%
2/175 • Number of events 2 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
0.00%
0/82 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
0.00%
0/81 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.57%
1/175 • Number of events 1 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
0.00%
0/82 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
0.00%
0/81 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.57%
1/175 • Number of events 1 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
0.00%
0/82 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
0.00%
0/81 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
|
Infections and infestations
Gastrointestinal infection/
|
0.00%
0/175 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
1.2%
1/82 • Number of events 1 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
0.00%
0/81 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture/
|
0.00%
0/175 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
1.2%
1/82 • Number of events 1 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
0.00%
0/81 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/175 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
1.2%
1/82 • Number of events 1 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
0.00%
0/81 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/175 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
0.00%
0/82 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
1.2%
1/81 • Number of events 1 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/175 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
0.00%
0/82 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
1.2%
1/81 • Number of events 1 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
|
Renal and urinary disorders
Renal Colic
|
0.00%
0/175 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
1.2%
1/82 • Number of events 1 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
0.00%
0/81 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
Other adverse events
| Measure |
Test Product (TX05 Only)
n=175 participants at risk
IV trastuzumab (TX05) 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles
TX05 (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment.
These subjects received TX05 on the TX05-03 study and continued to receive TX05 in this extension study.
|
Reference Therapy (Herceptin Only)
n=82 participants at risk
IV trastuzumab (Herceptin) TX05 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles
Herceptin (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment.
These subjects received Herceptin on the TX05-03 study and continued to receive Herceptin in this extension study.
|
Test Product (Herceptin/TX05 Transition)
n=81 participants at risk
IV trastuzumab (TX05) 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles
TX05 (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment.
These subjects received Herceptin on the TX05-03 study and were randomized to receive TX05 in this extension study.
|
|---|---|---|---|
|
Infections and infestations
Respiratory Tract Infection
|
3.4%
6/175 • Number of events 6 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
2.4%
2/82 • Number of events 2 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
6.2%
5/81 • Number of events 5 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
|
Investigations
Alanine Aminotransferase Increased
|
5.7%
10/175 • Number of events 11 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
2.4%
2/82 • Number of events 6 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
1.2%
1/81 • Number of events 1 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
|
Investigations
Aspartate Aminotransferase Increased
|
5.1%
9/175 • Number of events 10 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
1.2%
1/82 • Number of events 3 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
3.7%
3/81 • Number of events 3 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
|
Nervous system disorders
Headache
|
5.1%
9/175 • Number of events 13 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
6.1%
5/82 • Number of events 8 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
3.7%
3/81 • Number of events 4 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.0%
7/175 • Number of events 8 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
6.1%
5/82 • Number of events 5 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
2.5%
2/81 • Number of events 2 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
|
General disorders
Asthenia
|
5.7%
10/175 • Number of events 12 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
4.9%
4/82 • Number of events 4 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
3.7%
3/81 • Number of events 4 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
|
Injury, poisoning and procedural complications
Radiation Skin Injury
|
7.4%
13/175 • Number of events 13 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
6.1%
5/82 • Number of events 5 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
0.00%
0/81 • Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 45), with the exception of any ongoing study drug-related AEs, which were to be followed until the event was resolved, considered stable, or the investigator determined the AE was no longer clinically significant.
Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER