Trial Outcomes & Findings for A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Patients With Metastatic or Locally Advanced Breast Cancer (NCT NCT02015676)
NCT ID: NCT02015676
Last Updated: 2015-03-12
Results Overview
For measurable disease, CR was defined as the disappearance of all clinically detectable disease determined by 2 observations not less than 4 weeks apart; and PR was defined as a 50 percent (%) decrease in the sum of the products of the 2 greatest diameters of all measurable lesions by 2 observations not less than 4 weeks apart, and no appearance of new lesions or progression of any lesion. For immeasurable disease, CR was defined as the complete disappearance of all known disease for at least 4 weeks; and PR was defined as an estimated decrease in tumor size of 50% or more for at least 4 weeks.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
69 participants
Primary outcome timeframe
Baseline (BL), Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
Results posted on
2015-03-12
Participant Flow
Participant milestones
| Measure |
Trastuzumab, Doxorubicin, Paclitaxel; Phase I
Participants received an initial loading dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 40 mg per square meter (mg/m\^2), IV, once every 3 weeks, from Week 1. If no dose-limiting toxicity (DLT) was observed in greater than or equal to (≥) two-thirds (2/3) of cohort for 2 treatment cycles, the dose was increased to 50 mg/m\^2, IV, and continued for 6 cycles; and paclitaxel 60 mg/m\^2, IV, once per week, starting at Week 19; if no DLT was observed in ≥2/3 of cohort for 2 treatment cycles, the dose was increased to 70 mg/m\^2, IV, and subsequently 80 mg/m\^2, IV, and continued until disease progression.
|
Trastuzumab, Doxorubicin, Paclitaxel; Phase II
Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m\^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m\^2, IV, once per week, from Week 19 until disease progression.
|
Trastuzumab Doxorubicin, Paclitaxel; Phase I and Phase II
During Phase I, participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 40 mg/m\^2, IV, once every 3 weeks, for 2 treatment cycles, then the dose was increased to 50 mg/m\^2, IV, and continued for 6 cycles; and paclitaxel 60 mg/m\^2, IV, once per week, starting at Week 19 for 2 treatment cycles, then the dose was increased to 70 mg/m\^2, IV, and subsequently 80 mg/m\^2, IV, and continued until disease progression. In Phase II, participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m\^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m\^2, IV, once per week, from Week 19 until disease progression.
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
48
|
6
|
|
Overall Study
COMPLETED
|
6
|
14
|
3
|
|
Overall Study
NOT COMPLETED
|
9
|
34
|
3
|
Reasons for withdrawal
| Measure |
Trastuzumab, Doxorubicin, Paclitaxel; Phase I
Participants received an initial loading dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 40 mg per square meter (mg/m\^2), IV, once every 3 weeks, from Week 1. If no dose-limiting toxicity (DLT) was observed in greater than or equal to (≥) two-thirds (2/3) of cohort for 2 treatment cycles, the dose was increased to 50 mg/m\^2, IV, and continued for 6 cycles; and paclitaxel 60 mg/m\^2, IV, once per week, starting at Week 19; if no DLT was observed in ≥2/3 of cohort for 2 treatment cycles, the dose was increased to 70 mg/m\^2, IV, and subsequently 80 mg/m\^2, IV, and continued until disease progression.
|
Trastuzumab, Doxorubicin, Paclitaxel; Phase II
Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m\^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m\^2, IV, once per week, from Week 19 until disease progression.
|
Trastuzumab Doxorubicin, Paclitaxel; Phase I and Phase II
During Phase I, participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 40 mg/m\^2, IV, once every 3 weeks, for 2 treatment cycles, then the dose was increased to 50 mg/m\^2, IV, and continued for 6 cycles; and paclitaxel 60 mg/m\^2, IV, once per week, starting at Week 19 for 2 treatment cycles, then the dose was increased to 70 mg/m\^2, IV, and subsequently 80 mg/m\^2, IV, and continued until disease progression. In Phase II, participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m\^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m\^2, IV, once per week, from Week 19 until disease progression.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
18
|
0
|
|
Overall Study
Lack of Efficacy
|
2
|
4
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
7
|
1
|
|
Overall Study
Administrative reasons
|
0
|
3
|
1
|
|
Overall Study
Death
|
0
|
1
|
0
|
|
Overall Study
Disease progression
|
3
|
1
|
1
|
Baseline Characteristics
A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Patients With Metastatic or Locally Advanced Breast Cancer
Baseline characteristics by cohort
| Measure |
Trastuzumab, Doxorubicin, Paclitaxel; Phase I
n=15 Participants
Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 40 mg/m\^2, IV, once every 3 weeks, from Week 1. If no DLT was observed in ≥2/3 of cohort for 2 treatment cycles, the dose was increased to 50 mg/m\^2, IV, and continued for 6 cycles; and paclitaxel 60 mg/m\^2, IV, once per week, starting at Week 19; if no DLT was observed in ≥2/3 of cohort for 2 treatment cycles, the dose was increased to 70 mg/m\^2, IV, and subsequently 80 mg/m\^2, IV, and continued until disease progression.
|
Trastuzumab, Doxorubicin, Paclitaxel; Phase II
n=48 Participants
Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m\^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m\^2, IV, once per week, from Week 19 until disease progression.
|
Trastuzumab, Doxorubicin, Paclitaxel; Phase II and II
n=6 Participants
During Phase I, participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 40 mg/m\^2, IV, once every 3 weeks, for 2 treatment cycles, then the dose was increased to 50 mg/m\^2, IV, and continued for 6 cycles; and paclitaxel 60 mg/m\^2, IV, once per week, starting at Week 19 for 2 treatment cycles, then the dose was increased to 70 mg/m\^2, IV, and subsequently 80 mg/m\^2, IV, and continued until disease progression. In Phase II, participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m\^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m\^2, IV, once per week, from Week 19 until disease progression.
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.73 years
STANDARD_DEVIATION 12.42 • n=5 Participants
|
52.98 years
STANDARD_DEVIATION 12.33 • n=7 Participants
|
44.33 years
STANDARD_DEVIATION 15.36 • n=5 Participants
|
52.61 years
STANDARD_DEVIATION 12.70 • n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (BL), Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)Population: All participants enrolled in Phase II of this study were included in the analysis.
For measurable disease, CR was defined as the disappearance of all clinically detectable disease determined by 2 observations not less than 4 weeks apart; and PR was defined as a 50 percent (%) decrease in the sum of the products of the 2 greatest diameters of all measurable lesions by 2 observations not less than 4 weeks apart, and no appearance of new lesions or progression of any lesion. For immeasurable disease, CR was defined as the complete disappearance of all known disease for at least 4 weeks; and PR was defined as an estimated decrease in tumor size of 50% or more for at least 4 weeks.
Outcome measures
| Measure |
Trastuzumab, Doxorubicin, Paclitaxel; Phase II
n=54 Participants
Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m\^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m\^2, IV, once per week, from Week 19 until disease progression.
|
|---|---|
|
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to World Health Organization (WHO) Handbook for Reporting Results of Cancer Treatment
CR
|
51.85 percentage of participants
|
|
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to World Health Organization (WHO) Handbook for Reporting Results of Cancer Treatment
PR
|
46.30 percentage of participants
|
SECONDARY outcome
Timeframe: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)Population: All participants enrolled in Phase II of this study were included in the analysis.
Disease progression was defined as the time from the start of treatment to the date of the first recorded incident of disease progression, or the date of death due any cause. For measurable disease, disease progression was defined as a ≥25% increase in the sum of the products of diameters of 1 or more measurable lesions with a minimal area of greater than (\>)2 square centimeters (cm\^2), or the appearance of new lesions; and for malignant lesions with a minimal area of 2 cm\^2, an increase of ≥1 cm\^2. For immeasurable disease, disease progression was defined as the appearance of any new lesion not previously identified or an estimated increase of ≥50% in existent lesions.
Outcome measures
| Measure |
Trastuzumab, Doxorubicin, Paclitaxel; Phase II
n=54 Participants
Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m\^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m\^2, IV, once per week, from Week 19 until disease progression.
|
|---|---|
|
Time to Disease Progression - Percentage of Participants With an Event
|
40.74 percentage of participants
|
SECONDARY outcome
Timeframe: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)Population: All participants enrolled in Phase II of this study were included in the analysis.
The median time, in months, from the start of treatment to disease progression event.
Outcome measures
| Measure |
Trastuzumab, Doxorubicin, Paclitaxel; Phase II
n=54 Participants
Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m\^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m\^2, IV, once per week, from Week 19 until disease progression.
|
|---|---|
|
Time to Disease Progression
|
43.3018 months
Interval 24.0821 to
Upper limit of the 95% confidence interval (CI) could not be estimated because the largest observation was censored and the estimation was restricted to the largest event time.
|
SECONDARY outcome
Timeframe: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)Population: All participants enrolled in Phase II of this study were included in the analysis.
Treatment response was defined as the time from the start of treatment to the date of recorded CR or PR of measurable disease.
Outcome measures
| Measure |
Trastuzumab, Doxorubicin, Paclitaxel; Phase II
n=54 Participants
Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m\^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m\^2, IV, once per week, from Week 19 until disease progression.
|
|---|---|
|
Time to Treatment Response - Percentage of Participants With an Event
|
98.15 percentage participants
|
SECONDARY outcome
Timeframe: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)Population: All participants enrolled in Phase II of this study were included in the analysis.
The median time, in months, from the start of treatment to treatment response event.
Outcome measures
| Measure |
Trastuzumab, Doxorubicin, Paclitaxel; Phase II
n=54 Participants
Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m\^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m\^2, IV, once per week, from Week 19 until disease progression.
|
|---|---|
|
Time to Treatment Response
|
1.87269 months
Interval 1.83984 to 1.9384
|
SECONDARY outcome
Timeframe: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)Population: Only participants with a response were included in the analysis.
Duration of response was defined as the time from date CR was first recorded to the date progressive disease (PD) was first noted. For measurable disease, PD was defined as a ≥25% increase in the sum of the products of diameters of 1 or more measurable lesions with a minimal area of \>2 cm\^2, or the appearance of new lesions; and for malignant lesions with a minimal area of 2 cm\^2, an increase of ≥1 cm\^2. For immeasurable disease, PD was defined as the appearance of any new lesion not previously identified or an estimated increase of ≥50% in existent lesions.
Outcome measures
| Measure |
Trastuzumab, Doxorubicin, Paclitaxel; Phase II
n=53 Participants
Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m\^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m\^2, IV, once per week, from Week 19 until disease progression.
|
|---|---|
|
Duration of Response - Percentage of Participants With an Event
|
39.62 percentage of participants
|
SECONDARY outcome
Timeframe: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)Population: All participants enrolled in Phase II of this study were included in the analysis.
The median time, in months, from enrollment to duration of response event to Week 52.
Outcome measures
| Measure |
Trastuzumab, Doxorubicin, Paclitaxel; Phase II
n=54 Participants
Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m\^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m\^2, IV, once per week, from Week 19 until disease progression.
|
|---|---|
|
Duration of Response
|
41.1006 months
Interval 20.961 to
Upper limit of the 95% CI could not be estimated because the largest observation was censored and the estimation was restricted to the largest event time.
|
SECONDARY outcome
Timeframe: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)Population: All participants enrolled in Phase II of this study were included in the analysis.
Therapy failure was defined as the date of the start of therapy to the date of withdrawal due to adverse events, progressive disease/insufficient therapeutic response, death, failure to return, or refusal of treatment/lack of cooperation/withdrawal of consent. Participants were censored at the last dose of treatment if no event was recorded.
Outcome measures
| Measure |
Trastuzumab, Doxorubicin, Paclitaxel; Phase II
n=54 Participants
Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m\^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m\^2, IV, once per week, from Week 19 until disease progression.
|
|---|---|
|
Time to Therapy Failure - Percentage of Participants With an Event
|
81.48 percentage of participants
|
SECONDARY outcome
Timeframe: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)Population: All participants enrolled in Phase II of this study were included in the analysis.
The median time, in months, from treatment start to therapy failure event. Participants were censored at the last date of treatment if no event was recorded.
Outcome measures
| Measure |
Trastuzumab, Doxorubicin, Paclitaxel; Phase II
n=54 Participants
Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m\^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m\^2, IV, once per week, from Week 19 until disease progression.
|
|---|---|
|
Time to Therapy Failure
|
24.0821 months
Interval 17.5113 to 35.6797
|
SECONDARY outcome
Timeframe: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)Population: All participants enrolled in Phase II of this study were included in the analysis.
OS was defined as the time from the date of the start of treatment to the date of death or the last date the participant was known to be alive.
Outcome measures
| Measure |
Trastuzumab, Doxorubicin, Paclitaxel; Phase II
n=54 Participants
Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m\^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m\^2, IV, once per week, from Week 19 until disease progression.
|
|---|---|
|
Overall Survival (OS) - Percentage of Participants With an Event
|
3.70 percentage of participants
|
SECONDARY outcome
Timeframe: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)Population: All participants enrolled in Phase II of this study were included in the analysis.
The time, in months, from the start of treatment to OS event. The mean survival time and it's standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.
Outcome measures
| Measure |
Trastuzumab, Doxorubicin, Paclitaxel; Phase II
n=54 Participants
Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m\^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m\^2, IV, once per week, from Week 19 until disease progression.
|
|---|---|
|
Overall Survival
|
7.6909 months
Standard Error 0.1338
|
Adverse Events
Trastuzumab, Doxorubicin, Paclitaxel; Phase I & II
Serious events: 26 serious events
Other events: 63 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Trastuzumab, Doxorubicin, Paclitaxel; Phase I & II
n=69 participants at risk
Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m\^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m\^2, IV, once per week, from Week 19 until disease progression.
|
|---|---|
|
General disorders
Febrile neutropenia
|
17.4%
12/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Gastrointestinal disorders
Intestinal obstruction NOS
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Cardiac disorders
Cardiac failure NOS
|
2.9%
2/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Infections and infestations
Endocarditis
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Infections and infestations
Pancreatitis NOS
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.9%
2/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.9%
2/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Gastrointestinal disorders
Diarrhoea NOS
|
2.9%
2/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Infections and infestations
Pancreatitis
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Infections and infestations
Respiratory tract infection NOS
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia NOS
|
2.9%
2/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Infections and infestations
Upper respiratory tract infection NOS
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Blood and lymphatic system disorders
Thrombophlebitis
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Blood and lymphatic system disorders
Anaemia NOS
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Blood and lymphatic system disorders
Acute febrile neutrophilic dermatosis
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Infections and infestations
Staphylococcal infection
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Cardiac disorders
Ejection fraction decreased
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
General disorders
Mucosal inflammation NOS
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
Other adverse events
| Measure |
Trastuzumab, Doxorubicin, Paclitaxel; Phase I & II
n=69 participants at risk
Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m\^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m\^2, IV, once per week, from Week 19 until disease progression.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain NOS
|
7.2%
5/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
15.9%
11/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
78.3%
54/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Reproductive system and breast disorders
Amenorrhoea NOS
|
13.0%
9/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Blood and lymphatic system disorders
Anaemia NOS
|
10.1%
7/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Gastrointestinal disorders
Anal fissure
|
2.9%
2/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Anorexia
|
14.5%
10/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Psychiatric disorders
Anxiety symptoms
|
2.9%
2/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Nervous system disorders
Aphonia
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.9%
11/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
General disorders
Asthenia
|
50.7%
35/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
21.7%
15/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Hepatobiliary disorders
Biliary colic
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Investigations
Blood bilirubin increased
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Body tinea
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.7%
6/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Gastrointestinal disorders
Bowel sounds abnormal
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast abscess
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast haemorrhage
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Reproductive system and breast disorders
Breast pain
|
2.9%
2/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis NOS
|
2.9%
2/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm NOS
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Cardiac disorders
Cardiotoxicty
|
2.9%
2/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
General disorders
Catarrh
|
7.2%
5/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Infections and infestations
Catheter related infection
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Infections and infestations
Cellulitis
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Gastrointestinal disorders
Cheilitis
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
General disorders
Chest pain
|
4.3%
3/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
General disorders
Chest wall pain
|
2.9%
2/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Eye disorders
Conjunctivitis
|
15.9%
11/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Gastrointestinal disorders
Constipation
|
14.5%
10/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.0%
9/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Renal and urinary disorders
Cystitis-like symptom
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
General disorders
Death NOS
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Psychiatric disorders
Depression
|
11.6%
8/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Dermatitis NOS
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Dermatitis radiation NOS
|
10.1%
7/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Gastrointestinal disorders
Diarrhoea NOS
|
42.0%
29/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Nervous system disorders
Dizziness
|
7.2%
5/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Immune system disorders
Drug hypersensitivity
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Gastrointestinal disorders
Dry mouth
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.9%
2/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Nervous system disorders
Dysaesthesia
|
4.3%
3/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Gastrointestinal disorders
Dysgeusia
|
7.2%
5/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Gastrointestinal disorders
Dyspepsia
|
17.4%
12/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Gastrointestinal disorders
Dysphagia
|
2.9%
2/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.9%
11/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Renal and urinary disorders
Dysuria
|
2.9%
2/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Ear and labyrinth disorders
Ear pain
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Cardiac disorders
Ejection fraction decreased
|
15.9%
11/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
18.8%
13/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
18.8%
13/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Nervous system disorders
Extrapyramidal disorder
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
General disorders
Face oedema
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
General disorders
Fatigue
|
24.6%
17/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Infections and infestations
Febrile neutropenia
|
2.9%
2/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Vascular disorders
Flushing
|
5.8%
4/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Infections and infestations
Furuncle
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Gastrointestinal disorders
Gastroenteritis NOS
|
2.9%
2/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Gastrointestinal disorders
Gingival pain
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Gastrointestinal disorders
Haematochezia
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Investigations
Haemoglobin abnormal
|
8.7%
6/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Gastrointestinal disorders
Haemorrhoids
|
8.7%
6/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Nervous system disorders
Headache
|
13.0%
9/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Infections and infestations
Herpes simplex
|
4.3%
3/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Infections and infestations
Herpes zoster
|
2.9%
2/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Infections and infestations
Hordeolum
|
2.9%
2/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Immune system disorders
Hypersensitivity NOS
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
General disorders
Hypophonesis
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Vascular disorders
Hypotension NOS
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
General disorders
Influenza like illness
|
5.8%
4/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Infections and infestations
Influenza viral infections
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Injury asphyxiation
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Psychiatric disorders
Insomnia
|
10.1%
7/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
General disorders
Intermittent pyrexia
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Intertrigo candida
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Eye disorders
Lacrimation increased
|
2.9%
2/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Infections and infestations
Laryngitis NOS
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Blood and lymphatic system disorders
Leukopenia NOS
|
4.3%
3/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort NOS
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Infections and infestations
Lymphangitis
|
2.9%
2/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Vascular disorders
Lymphoedema NOS
|
13.0%
9/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Immune system disorders
Milk allergy
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Mucosal inflammation NOS
|
58.0%
40/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness NOS
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.0%
9/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mycosis fungoides
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Eye disorders
Mydriasis
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
General disorders
Nail discolouration
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
General disorders
Nail discomfort
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
General disorders
Nail disorder NOS
|
33.3%
23/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Infections and infestations
Nail infection
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
General disorders
Nail toxicity
|
7.2%
5/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
2.9%
2/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Infections and infestations
Nasopharyngitis
|
4.3%
3/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Gastrointestinal disorders
Nausea
|
52.2%
36/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.9%
2/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Psychiatric disorders
Nervousness
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Nervous system disorders
Neuropathic pain
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Nervous system disorders
Neuropathy NOS
|
7.2%
5/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Nervous system disorders
Neurotoxicity NOS
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Blood and lymphatic system disorders
Neutropenia
|
30.4%
21/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
General disorders
Not coded
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
General disorders
Odynophagia
|
4.3%
3/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
General disorders
Oedema NOS
|
5.8%
4/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
General disorders
Oedema peripheral
|
27.5%
19/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Gastrointestinal disorders
Oesophagitis NOS
|
2.9%
2/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
13.0%
9/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Infections and infestations
Oral infection
|
2.9%
2/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal candidiasis
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Infections and infestations
Otitis media NOS
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.9%
2/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
General disorders
Pain NOS
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Palmar erythema
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
14.5%
10/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Cardiac disorders
Palpitations
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Nervous system disorders
Paraesthesia
|
26.1%
18/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Nervous system disorders
Paralysis
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Blood and lymphatic system disorders
Paratracheal lymphadenopathy
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
General disorders
Performance status decreased
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Nervous system disorders
Peripheral neuropathy NOS
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.7%
6/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Infections and infestations
Pharyngitis
|
4.3%
3/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Vascular disorders
Phlebitis NOS
|
2.9%
2/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder NOS
|
5.8%
4/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Renal and urinary disorders
Pollakiuria
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Post procedural diarrhoea
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Post procedural vomiting
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Gastrointestinal disorders
Proctalgia
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.1%
7/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Eye disorders
Pupils unequal
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
General disorders
Pyrexia
|
33.3%
23/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Rash NOS
|
14.5%
10/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Gastrointestinal disorders
Rectal tenesmus
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.3%
3/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
General disorders
Rigors
|
10.1%
7/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
General disorders
Scar pain
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Cardiac disorders
Sinus tachycardia
|
2.9%
2/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Infections and infestations
Sinusitis NOS
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
11.6%
8/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Infections and infestations
Skin infection
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Immune system disorders
Skin reaction
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
7.2%
5/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Gastrointestinal disorders
Stomatitis
|
14.5%
10/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
General disorders
Sweating increased
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Nervous system disorders
Syncope
|
2.9%
2/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Cardiac disorders
Tachycardia NOS
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Infections and infestations
Tinea pedis
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Gastrointestinal disorders
Toothache
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Investigations
Transaminases increased
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Cardiac disorders
Transient ischaemic attack
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Infections and infestations
Upper respiratory tract infection NOS
|
5.8%
4/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Infections and infestations
Urinary tract infection NOS
|
5.8%
4/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Infections and infestations
Varicella
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Vascular disorders
Varicophlebitis
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Vascular disorders
Varicose veins NOS
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Cardiac disorders
Ventricular extrasystoles
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Eye disorders
Vision blurred
|
1.4%
1/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Gastrointestinal disorders
Vomiting NOS
|
37.7%
26/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
|
Investigations
Weight increased
|
7.2%
5/69 • BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER