Trial Outcomes & Findings for Neo ALTTO (Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) Study (NCT NCT00553358)
NCT ID: NCT00553358
Last Updated: 2021-09-21
Results Overview
Pathological complete response is defined as no invasive cancer in the breast or only non-invasive in situ cancer in the breast specimen. Surgical breast and axillary node resection specimens were evaluated for pathologic tumor response according to National Surgical Adjuvant Breast and Bowel Project (NSABP) guidelines, which do not take into account the histological nodal status.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
455 participants
Primary outcome timeframe
Weeks 20 to 22
Results posted on
2021-09-21
Participant Flow
Participant milestones
| Measure |
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
Lapatinib 1500 mg
Oral lapatinib (1500 milligrams \[mg\] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared \[mg/m\^2\]) intravenous (IV) for an additional 12 weeks
|
Trastuzumab 2 mg/kg
Trastuzumab (4 mg/kilograms \[kg\] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
152
|
154
|
149
|
|
Overall Study
COMPLETED
|
73
|
58
|
61
|
|
Overall Study
NOT COMPLETED
|
79
|
96
|
88
|
Reasons for withdrawal
| Measure |
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
Lapatinib 1500 mg
Oral lapatinib (1500 milligrams \[mg\] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared \[mg/m\^2\]) intravenous (IV) for an additional 12 weeks
|
Trastuzumab 2 mg/kg
Trastuzumab (4 mg/kilograms \[kg\] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
|---|---|---|---|
|
Overall Study
Randomized but did not receive treatment
|
3
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
22
|
26
|
18
|
|
Overall Study
Withdrew completely
|
23
|
33
|
34
|
|
Overall Study
Died during clinical follow-up
|
25
|
29
|
32
|
|
Overall Study
Not dead but were last followed-up prior to 9 years + 6 months after randomization
|
4
|
2
|
2
|
|
Overall Study
Died after clinical follow-up ended
|
1
|
2
|
0
|
|
Overall Study
Withdrew (survival only) - alive at end of survival follow-up
|
1
|
1
|
1
|
Baseline Characteristics
Neo ALTTO (Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) Study
Baseline characteristics by cohort
| Measure |
Lapatinib 1500 mg
n=154 Participants
Oral lapatinib (1500 milligrams \[mg\] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared \[mg/m\^2\]) intravenous (IV) for an additional 12 weeks
|
Trastuzumab 2 mg/kg
n=149 Participants
Trastuzumab (4 mg/kilograms \[kg\] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
n=152 Participants
Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
Total
n=455 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race/Ethnicity, Customized
Asian - Central/South
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
|
Age, Continuous
|
50.0 Years
n=99 Participants
|
49.0 Years
n=107 Participants
|
50.0 Years
n=206 Participants
|
50.0 Years
n=7 Participants
|
|
Sex: Female, Male
Female
|
154 Participants
n=99 Participants
|
149 Participants
n=107 Participants
|
152 Participants
n=206 Participants
|
455 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
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
42 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian - East
|
30 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
89 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian - South East
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black or African American/African Heritage
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African Heritage
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White - Caucasian European Heritage
|
97 Participants
n=99 Participants
|
93 Participants
n=107 Participants
|
92 Participants
n=206 Participants
|
282 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Missing
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Number of participants with tumor cells of the indicated histologic grade
Well differentiated
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Number of participants with tumor cells of the indicated histologic grade
Moderately differentiated
|
56 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
172 Participants
n=7 Participants
|
|
Number of participants with tumor cells of the indicated histologic grade
Poorly differentiated
|
73 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
205 Participants
n=7 Participants
|
|
Number of participants with tumor cells of the indicated histologic grade
Differentiation cannot be assessed
|
22 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
65 Participants
n=7 Participants
|
|
Number of participants with tumor cells of the indicated histologic grade
Missing
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Number of participants with lymph nodes (LNs) of the indicated clinical N stage
N0
|
34 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
123 Participants
n=7 Participants
|
|
Number of participants with lymph nodes (LNs) of the indicated clinical N stage
N1
|
95 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
260 Participants
n=7 Participants
|
|
Number of participants with lymph nodes (LNs) of the indicated clinical N stage
N2 (including N2a and N2b)
|
19 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
47 Participants
n=7 Participants
|
|
Number of participants with lymph nodes (LNs) of the indicated clinical N stage
N3 (including N3a, N3b, and N3c)
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
|
Number of participants with lymph nodes (LNs) of the indicated clinical N stage
Nx
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Number of participants with the indicated IHC results
Not applicable
|
60 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
174 Participants
n=7 Participants
|
|
Number of participants with the indicated IHC results
Equivocal: Score of 2+
|
9 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
|
Number of participants with the indicated IHC results
Positive: Score of 3+
|
81 Participants
n=99 Participants
|
89 Participants
n=107 Participants
|
76 Participants
n=206 Participants
|
246 Participants
n=7 Participants
|
|
Number of participants with the indicated IHC results
Negative: Score of 0-1+
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Number of participants with the indicated IHC results
Non interpretable
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Number of participants with the indicated FISH results
Not applicable
|
38 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
121 Participants
n=7 Participants
|
|
Number of participants with the indicated FISH results
Amplified
|
115 Participants
n=99 Participants
|
105 Participants
n=107 Participants
|
109 Participants
n=206 Participants
|
329 Participants
n=7 Participants
|
|
Number of participants with the indicated FISH results
Not amplified
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Number of participants with the indicated FISH results
Not interpretable
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Weeks 20 to 22Population: Intent-to-Treat (ITT) Population: all participants randomized to treatment, except for those who withdrew their consent to use any of their data (permitted by law in certain countries) prior to receiving any study medication
Pathological complete response is defined as no invasive cancer in the breast or only non-invasive in situ cancer in the breast specimen. Surgical breast and axillary node resection specimens were evaluated for pathologic tumor response according to National Surgical Adjuvant Breast and Bowel Project (NSABP) guidelines, which do not take into account the histological nodal status.
Outcome measures
| Measure |
Lapatinib 1500 mg
n=154 Participants
Oral lapatinib (1500 milligrams \[mg\] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared \[mg/m\^2\]) intravenous (IV) for an additional 12 weeks
|
Trastuzumab 2 mg/kg
n=149 Participants
Trastuzumab (4 mg/kilograms \[kg\] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
n=152 Participants
Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
|---|---|---|---|
|
Number of Participants With Pathological Complete Response (pCR) at the Time of Surgery
|
38 participants
|
44 participants
|
78 participants
|
SECONDARY outcome
Timeframe: Week 6Population: ITT Population
The number of participants with overall response (complete response and/or partial response) was evaluated using World Health Organization (WHO) criteria by clinical examination and by mammography and breast echography with bi-dimensional measurements at Week 6. As per WHO criteria: complete response is defined as the disappearance of all lesions; partial response is defined as a greater than 50% decrease in the sum of products of the greatest length and width of the largest lesion; progressive disease is defined as a greater than 25% increase in the sum of products of all measurable lesions.
Outcome measures
| Measure |
Lapatinib 1500 mg
n=154 Participants
Oral lapatinib (1500 milligrams \[mg\] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared \[mg/m\^2\]) intravenous (IV) for an additional 12 weeks
|
Trastuzumab 2 mg/kg
n=149 Participants
Trastuzumab (4 mg/kilograms \[kg\] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
n=152 Participants
Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
|---|---|---|---|
|
Number of Participants With Overall Response at Week 6
Overall Response
|
81 participants
|
45 participants
|
102 participants
|
|
Number of Participants With Overall Response at Week 6
No Change
|
57 participants
|
81 participants
|
33 participants
|
|
Number of Participants With Overall Response at Week 6
Progressive Disease
|
5 participants
|
11 participants
|
2 participants
|
|
Number of Participants With Overall Response at Week 6
Not Evaluated
|
7 participants
|
9 participants
|
12 participants
|
|
Number of Participants With Overall Response at Week 6
Missing Data
|
4 participants
|
3 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Time of surgery (Weeks 20 to 22)Population: ITT Population
The number of participants with overall response (complete response and/or partial response) was evaluated using WHO criteria by clinical examination and mammography and breast echography with bi-dimensional measurements at the time of surgery (Weeks 20 to 22). As per WHO criteria: complete response is defined as the disappearance of all lesions; partial response is defined as a greater than 50% decrease in the sum of products of the greatest length and width of the largest lesion; progressive disease is defined as a greater than 25% increase in the sum of products of all measurable lesions.
Outcome measures
| Measure |
Lapatinib 1500 mg
n=154 Participants
Oral lapatinib (1500 milligrams \[mg\] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared \[mg/m\^2\]) intravenous (IV) for an additional 12 weeks
|
Trastuzumab 2 mg/kg
n=149 Participants
Trastuzumab (4 mg/kilograms \[kg\] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
n=152 Participants
Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
|---|---|---|---|
|
Overall Response at the Time of Surgery
Overall Response
|
114 participants
|
105 participants
|
122 participants
|
|
Overall Response at the Time of Surgery
No Change
|
8 participants
|
16 participants
|
7 participants
|
|
Overall Response at the Time of Surgery
Progressive Disease
|
0 participants
|
2 participants
|
1 participants
|
|
Overall Response at the Time of Surgery
Not Evaluated
|
19 participants
|
20 participants
|
14 participants
|
|
Overall Response at the Time of Surgery
Missing Data
|
13 participants
|
6 participants
|
8 participants
|
SECONDARY outcome
Timeframe: Time of surgery (Weeks 20 to 22)Population: ITT Population. Participants with a lymph node status of pNX (i.e., regional lymph nodes cannot be assessed) were omitted from the analysis of node-negative participants.
Participants were assessed for node-negative lymph nodes at the time of surgery. As per the pathological TNM (Tumor, Node, Metastases) classification (pTNM) of malignant tumors: pN, absence or presence and extent of regional lymph node metastasis. Node-negative (pN0) participants had no regional lymph node metastasis. Although not assessed in this measure, pT is the extent of primary tumor, and pM is the absence or presence of distant metastasis.
Outcome measures
| Measure |
Lapatinib 1500 mg
n=139 Participants
Oral lapatinib (1500 milligrams \[mg\] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared \[mg/m\^2\]) intravenous (IV) for an additional 12 weeks
|
Trastuzumab 2 mg/kg
n=140 Participants
Trastuzumab (4 mg/kilograms \[kg\] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
n=137 Participants
Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
|---|---|---|---|
|
Number of Participants With Negative Lymph Nodes at the Time of Surgery
|
72 participants
|
82 participants
|
100 participants
|
SECONDARY outcome
Timeframe: At surgery (Weeks 20 to 22)Population: ITT Population
Participants were assessed for the type of surgery they underwent for breast cancer. Non-conservative surgery is defined as a radical or modified radical mastectomy. Conservative surgery is comprised of a lumpectomy, a quadrantectomy/segmentectomy, or a partial mastectomy. Participants who were not assessed as being candidates for non-conservative or conservative surgery were classified as non-operable.
Outcome measures
| Measure |
Lapatinib 1500 mg
n=154 Participants
Oral lapatinib (1500 milligrams \[mg\] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared \[mg/m\^2\]) intravenous (IV) for an additional 12 weeks
|
Trastuzumab 2 mg/kg
n=149 Participants
Trastuzumab (4 mg/kilograms \[kg\] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
n=152 Participants
Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
|---|---|---|---|
|
Number of Participants With Actual Indicated Surgery
Non-conservative
|
77 participants
|
85 participants
|
80 participants
|
|
Number of Participants With Actual Indicated Surgery
Conservative
|
66 participants
|
58 participants
|
63 participants
|
|
Number of Participants With Actual Indicated Surgery
Non-operable
|
11 participants
|
6 participants
|
9 participants
|
SECONDARY outcome
Timeframe: Week 6 and surgery (Weeks 20 to 22)Population: ITT Population
Mean change from baseline in tumor in tumor size. Change from baseline in tumor size was defined as tumor size at Week 6/ surgery (Weeks 20 to 22) minus tumor size at baseline. The difference in treatment arms was estimated for Lapatinib 1500 mg versus Trastuzumab 2 mg/kg and for Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg versus Trastuzumab 2 mg/kg.
Outcome measures
| Measure |
Lapatinib 1500 mg
n=154 Participants
Oral lapatinib (1500 milligrams \[mg\] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared \[mg/m\^2\]) intravenous (IV) for an additional 12 weeks
|
Trastuzumab 2 mg/kg
n=149 Participants
Trastuzumab (4 mg/kilograms \[kg\] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
n=152 Participants
Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
|---|---|---|---|
|
Mean Change From Baseline in Tumor Size at Week 6 and at Surgery
Week 6
|
-20.45 millimeters
Standard Deviation 18.43
|
-13.42 millimeters
Standard Deviation 16.44
|
-25.77 millimeters
Standard Deviation 19.91
|
|
Mean Change From Baseline in Tumor Size at Week 6 and at Surgery
Surgery (Weeks 20 to 22)
|
-41.01 millimeters
Standard Deviation 23.81
|
-35.47 millimeters
Standard Deviation 22.95
|
-43.59 millimeters
Standard Deviation 26.88
|
SECONDARY outcome
Timeframe: Week 6Population: ITT Population. Participants who did not start any treatment were excluded from analysis.
Participants with progressive disease at 4 week assessment that were permitted to commence treatment with paclitaxel.
Outcome measures
| Measure |
Lapatinib 1500 mg
n=149 Participants
Oral lapatinib (1500 milligrams \[mg\] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared \[mg/m\^2\]) intravenous (IV) for an additional 12 weeks
|
Trastuzumab 2 mg/kg
n=146 Participants
Trastuzumab (4 mg/kilograms \[kg\] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
n=149 Participants
Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
|---|---|---|---|
|
Number of Participants Starting Paclitaxel Before Completing 6 Weeks of Treatment With Either Lapatinib or Trastuzumab
|
8 participants
|
12 participants
|
6 participants
|
SECONDARY outcome
Timeframe: From randomization up to approximately year 10Population: Intent-to-Treat (ITT) Population: all participants randomized to treatment, except for those who withdrew their consent to use any of their data (permitted by law in certain countries) prior to receiving any study medication
Event free survival (EFS) is defined as the time from randomization to first EFS event. For subjects who had breast cancer surgery, EFS events were post-surgery breast cancer relapse, second primary malignancy or death without recurrence. For subjects who did not have breast cancer surgery, EFS events were death during clinical follow-up or non-completion of any neoadjuvant investigational product due to disease progression.
Outcome measures
| Measure |
Lapatinib 1500 mg
n=152 Participants
Oral lapatinib (1500 milligrams \[mg\] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared \[mg/m\^2\]) intravenous (IV) for an additional 12 weeks
|
Trastuzumab 2 mg/kg
n=154 Participants
Trastuzumab (4 mg/kilograms \[kg\] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
n=149 Participants
Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
|---|---|---|---|
|
Event-free Survival (EFS) - Median Clinical Follow-up
|
9.69 years
Interval 9.55 to 9.73
|
9.60 years
Interval 8.21 to 9.69
|
9.66 years
Interval 9.5 to 9.72
|
SECONDARY outcome
Timeframe: From randomization up to approximately year 10Population: Intent-to-Treat (ITT) Population: all participants randomized to treatment, except for those who withdrew their consent to use any of their data (permitted by law in certain countries) prior to receiving any study medication
Event free survival (EFS) is defined as the time from randomization to first EFS event. For subjects who had breast cancer surgery, EFS events were post-surgery breast cancer relapse, second primary malignancy or death without recurrence. For subjects who did not have breast cancer surgery, EFS events were death during clinical follow-up or non-completion of any neoadjuvant investigational product due to disease progression.
Outcome measures
| Measure |
Lapatinib 1500 mg
n=152 Participants
Oral lapatinib (1500 milligrams \[mg\] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared \[mg/m\^2\]) intravenous (IV) for an additional 12 weeks
|
Trastuzumab 2 mg/kg
n=154 Participants
Trastuzumab (4 mg/kilograms \[kg\] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
n=149 Participants
Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
|---|---|---|---|
|
Event-free Survival (EFS) - Events and Censoring
Number of subjects with EFS events
|
43 Number of Participants
|
47 Number of Participants
|
47 Number of Participants
|
|
Event-free Survival (EFS) - Events and Censoring
Number of subjects censored - total
|
109 Number of Participants
|
107 Number of Participants
|
102 Number of Participants
|
|
Event-free Survival (EFS) - Events and Censoring
Number of subjects censored - Clinical follow-up ongoing
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
|
Event-free Survival (EFS) - Events and Censoring
Number of subjects censored - Clinical follow-up ended - total
|
103 Number of Participants
|
105 Number of Participants
|
99 Number of Participants
|
|
Event-free Survival (EFS) - Events and Censoring
Number of subjects censored -Clinical follow-up ended - Completed study follow-up
|
61 Number of Participants
|
49 Number of Participants
|
58 Number of Participants
|
|
Event-free Survival (EFS) - Events and Censoring
Number of subjects censored - Clinical follow-up ended - Lost to follow-up
|
17 Number of Participants
|
20 Number of Participants
|
10 Number of Participants
|
|
Event-free Survival (EFS) - Events and Censoring
Number of subjects censored - Clinical follow-up ended - Withdrew (but consent for survival f/u)
|
3 Number of Participants
|
6 Number of Participants
|
4 Number of Participants
|
|
Event-free Survival (EFS) - Events and Censoring
Number of subjects censored - Clinical follow-up ended - Withdrew
|
22 Number of Participants
|
30 Number of Participants
|
27 Number of Participants
|
|
Event-free Survival (EFS) - Events and Censoring
Number of subjects censored - Other
|
6 Number of Participants
|
2 Number of Participants
|
3 Number of Participants
|
SECONDARY outcome
Timeframe: From randomization up to approximately year 10Population: Intent-to-Treat (ITT) Population: all participants randomized to treatment, except for those who withdrew their consent to use any of their data (permitted by law in certain countries) prior to receiving any study medication
Overall survival is defined as the period from randomization until death (from any cause). OS was assessed annually for up to 10 years after the randomization of the last participant into the study.
Outcome measures
| Measure |
Lapatinib 1500 mg
n=152 Participants
Oral lapatinib (1500 milligrams \[mg\] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared \[mg/m\^2\]) intravenous (IV) for an additional 12 weeks
|
Trastuzumab 2 mg/kg
n=154 Participants
Trastuzumab (4 mg/kilograms \[kg\] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
n=149 Participants
Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
|---|---|---|---|
|
Overall Survival (OS) - Median Survival Follow-up
|
9.70 years
Interval 9.6 to 9.76
|
9.62 years
Interval 8.86 to 9.67
|
9.64 years
Interval 9.35 to 9.71
|
SECONDARY outcome
Timeframe: From randomization up to approximately year 10Population: Intent-to-Treat (ITT) Population: all participants randomized to treatment, except for those who withdrew their consent to use any of their data (permitted by law in certain countries) prior to receiving any study medication
Overall survival is defined as the period from randomization until death (from any cause). OS was assessed annually for up to 10 years after the randomization of the last participant into the study.
Outcome measures
| Measure |
Lapatinib 1500 mg
n=152 Participants
Oral lapatinib (1500 milligrams \[mg\] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared \[mg/m\^2\]) intravenous (IV) for an additional 12 weeks
|
Trastuzumab 2 mg/kg
n=154 Participants
Trastuzumab (4 mg/kilograms \[kg\] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
n=149 Participants
Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
|---|---|---|---|
|
Overall Survival (OS) - Deaths and Censoring
Number of subjects censored - Other
|
6 Number of Participants
|
2 Number of Participants
|
3 Number of Participants
|
|
Overall Survival (OS) - Deaths and Censoring
Number of subjects censored - Survival follow-up ended - total
|
120 Number of Participants
|
121 Number of Participants
|
114 Number of Participants
|
|
Overall Survival (OS) - Deaths and Censoring
Number of subjects censored -Survival follow-up ended - Completed study follow-up
|
74 Number of Participants
|
59 Number of Participants
|
62 Number of Participants
|
|
Overall Survival (OS) - Deaths and Censoring
Number of subjects censored - Survival follow-up ended - Lost to follow-up
|
22 Number of Participants
|
27 Number of Participants
|
18 Number of Participants
|
|
Overall Survival (OS) - Deaths and Censoring
Number of subjects censored - Survival follow-up ended - Withdrew
|
24 Number of Participants
|
35 Number of Participants
|
34 Number of Participants
|
|
Overall Survival (OS) - Deaths and Censoring
Number of deaths due to any cause
|
26 Number of Participants
|
31 Number of Participants
|
32 Number of Participants
|
|
Overall Survival (OS) - Deaths and Censoring
Number of subjects censored - total
|
126 Number of Participants
|
123 Number of Participants
|
117 Number of Participants
|
|
Overall Survival (OS) - Deaths and Censoring
Number of subjects censored - Survival follow-up ongoing
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
SECONDARY outcome
Timeframe: up to year 10Population: For EFS, the landmark population was the subset of the ITT population who have not had an EFS event within 30 weeks after randomization and were still in clinical follow-up.
The landmark date is 30 weeks after a subject's randomization. Subjects with missing pCR status were not included in the landmark analysis. Clinical follow-up is the period during which the patient is monitored such that all recurrence or second primary malignancy (SPM) or contralateral breast cancer (CBC) events would be reported. Patients are considered in clinical follow-up from randomisation until one of the following occurs: lost to follow-up, withdrawal of consent, end of follow-up due to completion of year 10 visit, termination of study follow-up, or death.
Outcome measures
| Measure |
Lapatinib 1500 mg
n=136 Participants
Oral lapatinib (1500 milligrams \[mg\] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared \[mg/m\^2\]) intravenous (IV) for an additional 12 weeks
|
Trastuzumab 2 mg/kg
n=274 Participants
Trastuzumab (4 mg/kilograms \[kg\] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
n=410 Participants
Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
|---|---|---|---|
|
Assess Associations Between Locoregional Pathological Complete Response (pCR) and Event-free Survival (EFS) - Median Clinical Follow-up (EFS Landmark Population)
Median clinical follow-up - all subjects in the EFS landmark analysis
|
9.05 years
Interval 8.86 to 9.14
|
9.11 years
Interval 9.05 to 9.14
|
9.09 years
Interval 9.03 to 9.13
|
|
Assess Associations Between Locoregional Pathological Complete Response (pCR) and Event-free Survival (EFS) - Median Clinical Follow-up (EFS Landmark Population)
Median clinical follow-up- EFS landmark analysis - lapatinib + trastuzumab arm (n=67,71,138)
|
9.13 years
Interval 8.97 to 9.23
|
9.10 years
Interval 7.24 to 9.15
|
9.12 years
Interval 8.97 to 9.15
|
|
Assess Associations Between Locoregional Pathological Complete Response (pCR) and Event-free Survival (EFS) - Median Clinical Follow-up (EFS Landmark Population)
Median clinical follow-up - subjects in the EFS landmark analysis - lapatinib arm (n=30,104,134)
|
8.08 years
Interval 6.08 to 9.12
|
9.09 years
Interval 8.52 to 9.19
|
9.05 years
Interval 8.23 to 9.12
|
|
Assess Associations Between Locoregional Pathological Complete Response (pCR) and Event-free Survival (EFS) - Median Clinical Follow-up (EFS Landmark Population)
Median clinical follow-up - subjects in the EFS landmark analysis - trastuzumab arm (n=39,99,138)
|
8.98 years
Interval 8.38 to 9.21
|
9.12 years
Interval 9.03 to 9.25
|
9.11 years
Interval 8.96 to 9.17
|
SECONDARY outcome
Timeframe: up to year 10Population: For EFS, the landmark population was the subset of the ITT population who have not had an EFS event within 30 weeks after randomization and were still in clinical follow-up.
The landmark date is 30 weeks after a subject's randomization. Subjects with missing pCR status were not included in the landmark analysis. For patients who had breast cancer surgery, EFS events are post-surgery breast cancer relapse, second primary malignancy or death without recurrence. For patients who do not undergo breast cancer surgery, EFS events are death during clinical follow-up or non-completion of any neo-adjuvant investigational product due to disease progression or second primary malignancy or contralateral breast cancer.
Outcome measures
| Measure |
Lapatinib 1500 mg
n=136 Participants
Oral lapatinib (1500 milligrams \[mg\] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared \[mg/m\^2\]) intravenous (IV) for an additional 12 weeks
|
Trastuzumab 2 mg/kg
n=274 Participants
Trastuzumab (4 mg/kilograms \[kg\] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
n=410 Participants
Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
|---|---|---|---|
|
Assess Associations Between Locoregional Pathological Complete Response (pCR) and Event-free Survival (EFS) - Number of Participants With EFS Events (EFS Landmark Population)
All subjects in the EFS landmark analysis with EFS events
|
29 Number of participants
|
98 Number of participants
|
127 Number of participants
|
|
Assess Associations Between Locoregional Pathological Complete Response (pCR) and Event-free Survival (EFS) - Number of Participants With EFS Events (EFS Landmark Population)
Subjects in the EFS landmark analysis - lapatinib + trastuzumab arm with EFS events (n=67,71,138)
|
11 Number of participants
|
28 Number of participants
|
39 Number of participants
|
|
Assess Associations Between Locoregional Pathological Complete Response (pCR) and Event-free Survival (EFS) - Number of Participants With EFS Events (EFS Landmark Population)
Subjects in the EFS landmark analysis in the lapatinib arm with EFS events (n=30,104,134)
|
7 Number of participants
|
36 Number of participants
|
43 Number of participants
|
|
Assess Associations Between Locoregional Pathological Complete Response (pCR) and Event-free Survival (EFS) - Number of Participants With EFS Events (EFS Landmark Population)
Subjects in the EFS landmark analysis in the trastuzumab arm with EFS events (n=39,99,138)
|
11 Number of participants
|
34 Number of participants
|
45 Number of participants
|
SECONDARY outcome
Timeframe: up to year 10Population: For OS, the landmark population was the subset of the ITT population who were alive and were followed up for overall survival 30 weeks after randomization.
The landmark date is 30 weeks after a subject's randomization. Subjects with missing pCR status were not included in the landmark analysis. Patients are considered in survival follow-up from randomisation until one of the following occurs: lost to follow-up, withdrawal of consent, end of follow-up due to completion of year 10 visit, termination of study follow-up, or death. For subjects with no death recorded in the database, time to death is censored.
Outcome measures
| Measure |
Lapatinib 1500 mg
n=137 Participants
Oral lapatinib (1500 milligrams \[mg\] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared \[mg/m\^2\]) intravenous (IV) for an additional 12 weeks
|
Trastuzumab 2 mg/kg
n=283 Participants
Trastuzumab (4 mg/kilograms \[kg\] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
n=420 Participants
Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
|---|---|---|---|
|
Assess Associations Between Locoregional Pathological Complete Response (pCR) and and Overall Survival (OS) - Median Clinical Follow-up (OS Landmark Population)
Median survival follow-up - All subjects in the OS landmark analysis
|
9.10 years
Interval 8.97 to 9.18
|
9.09 years
Interval 9.03 to 9.12
|
9.09 years
Interval 9.04 to 9.13
|
|
Assess Associations Between Locoregional Pathological Complete Response (pCR) and and Overall Survival (OS) - Median Clinical Follow-up (OS Landmark Population)
Median survival follow-up - OS landmark analysis in the lapatinib + trastuzumab arm (n=67,72,139)
|
9.14 years
Interval 9.05 to 9.24
|
9.09 years
Interval 7.95 to 9.15
|
9.12 years
Interval 9.05 to 9.16
|
|
Assess Associations Between Locoregional Pathological Complete Response (pCR) and and Overall Survival (OS) - Median Clinical Follow-up (OS Landmark Population)
Median survival follow-up - OS landmark analysis in the lapatinib (n=30,109,139)
|
8.31 years
Interval 7.24 to 9.15
|
9.08 years
Interval 8.95 to 9.14
|
9.07 years
Interval 8.5 to 9.12
|
|
Assess Associations Between Locoregional Pathological Complete Response (pCR) and and Overall Survival (OS) - Median Clinical Follow-up (OS Landmark Population)
Median survival follow-up - OS landmark analysis in the trastuzumab arm (n=40,102,142)
|
8.98 years
Interval 8.02 to 9.21
|
9.09 years
Interval 8.51 to 9.15
|
9.07 years
Interval 8.86 to 9.14
|
SECONDARY outcome
Timeframe: up to year 10Population: For OS, the landmark population was the subset of the ITT population who were alive and were followed up for overall survival 30 weeks after randomization.
The landmark date is 30 weeks after a subject's randomization. Subjects with missing pCR status were not included in the landmark analysis. Includes deaths due to any cause.
Outcome measures
| Measure |
Lapatinib 1500 mg
n=137 Participants
Oral lapatinib (1500 milligrams \[mg\] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared \[mg/m\^2\]) intravenous (IV) for an additional 12 weeks
|
Trastuzumab 2 mg/kg
n=283 Participants
Trastuzumab (4 mg/kilograms \[kg\] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
n=420 Participants
Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
|---|---|---|---|
|
Assess Associations Between Locoregional Pathological Complete Response (pCR) and and Overall Survival (OS) - Number of Participants Who Died (OS Landmark Population)
All participants in the OS landmark analysis who died
|
15 Number of Participants
|
70 Number of Participants
|
85 Number of Participants
|
|
Assess Associations Between Locoregional Pathological Complete Response (pCR) and and Overall Survival (OS) - Number of Participants Who Died (OS Landmark Population)
Participants in the OS landmark analysis in the lapatinib + trastuzumab arm who died (n=67,72,139)
|
5 Number of Participants
|
19 Number of Participants
|
24 Number of Participants
|
|
Assess Associations Between Locoregional Pathological Complete Response (pCR) and and Overall Survival (OS) - Number of Participants Who Died (OS Landmark Population)
Participants in the OS landmark analysis in the lapatinib arm who died (n=30,109,139)
|
4 Number of Participants
|
26 Number of Participants
|
30 Number of Participants
|
|
Assess Associations Between Locoregional Pathological Complete Response (pCR) and and Overall Survival (OS) - Number of Participants Who Died (OS Landmark Population)
Participants in the OS landmark analysis in the trastuzumab arm who died (n=40,102,142)
|
6 Number of Participants
|
25 Number of Participants
|
31 Number of Participants
|
SECONDARY outcome
Timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.Population: Safety population
Outcome measures
| Measure |
Lapatinib 1500 mg
n=149 Participants
Oral lapatinib (1500 milligrams \[mg\] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared \[mg/m\^2\]) intravenous (IV) for an additional 12 weeks
|
Trastuzumab 2 mg/kg
n=151 Participants
Trastuzumab (4 mg/kilograms \[kg\] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
n=148 Participants
Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
|---|---|---|---|
|
To Assess Safety Via a Comparison of the Three Treatment Arms - to Measure On-treatment Primary Cardiac Endpoints
|
2 Participants
Interval 0.16 to 4.76
|
0 Participants
Interval 0.0 to 2.41
|
1 Participants
Interval 0.02 to 3.71
|
SECONDARY outcome
Timeframe: Week 2 and Week 6Population: Translational Data Set. Note that evaluable samples were not available for all participants.
Metabolic Response Rate determined by Positron Emission Tomography/Computed Tomography (PET/CT)
Outcome measures
| Measure |
Lapatinib 1500 mg
n=26 Participants
Oral lapatinib (1500 milligrams \[mg\] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared \[mg/m\^2\]) intravenous (IV) for an additional 12 weeks
|
Trastuzumab 2 mg/kg
n=26 Participants
Trastuzumab (4 mg/kilograms \[kg\] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
n=25 Participants
Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
|---|---|---|---|
|
Metabolic Response Rate Determined by Positron Emission Tomography/Computed Tomography (PET/CT)
Metabolic Response Rate (%) Determined by PET/CT at week 2
|
66.7 Percentage of participants
|
56.5 Percentage of participants
|
95.0 Percentage of participants
|
|
Metabolic Response Rate Determined by Positron Emission Tomography/Computed Tomography (PET/CT)
Metabolic Response Rate (%) Determined by PET/CT at week 6
|
60.9 Percentage of participants
|
43.5 Percentage of participants
|
78.9 Percentage of participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Translational Data Set. Note that evaluable samples were not available for all participants.
Biomarker levels of phosphatidylinositol 3-kinase (PI3K) catalytic subunit (PIK3CA) were assessed in participants at baseline.
Outcome measures
| Measure |
Lapatinib 1500 mg
n=124 Participants
Oral lapatinib (1500 milligrams \[mg\] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared \[mg/m\^2\]) intravenous (IV) for an additional 12 weeks
|
Trastuzumab 2 mg/kg
n=112 Participants
Trastuzumab (4 mg/kilograms \[kg\] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
n=119 Participants
Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
|---|---|---|---|
|
Percentage of Participants With the Indicated Biomarker Expression - PIK3CA.
|
23 Percentage of participants
|
19 Percentage of participants
|
25 Percentage of participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Translational Data Set. Note that evaluable samples were not available for all participants.
Biomarker levels of phosphate and tensin homolog deleted from chromosome 10 (PTEN) were assessed in participants at baseline.
Outcome measures
| Measure |
Lapatinib 1500 mg
n=123 Participants
Oral lapatinib (1500 milligrams \[mg\] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared \[mg/m\^2\]) intravenous (IV) for an additional 12 weeks
|
Trastuzumab 2 mg/kg
n=114 Participants
Trastuzumab (4 mg/kilograms \[kg\] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
n=112 Participants
Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
|---|---|---|---|
|
Percentage of Participants With the Indicated Biomarker Expression - PTEN.
Biomarker: PTEN by Cell Signalling Technology - PTEN Normal (%)
|
74 Percentage of participants
|
70 Percentage of participants
|
75 Percentage of participants
|
|
Percentage of Participants With the Indicated Biomarker Expression - PTEN.
Biomarker: PTEN by Cell Signalling Technology - PTEN Loss (%)
|
26 Percentage of participants
|
30 Percentage of participants
|
25 Percentage of participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Translational Data Set. Note that evaluable samples were not available for all participants.
Ratio (95% CI) of geometric means in p95 human epidermal growth factor receptor (p95HER2) expression in hormone-receptor (HR) positive patients with pathological complete response (pCR) vs no pCR
Outcome measures
| Measure |
Lapatinib 1500 mg
n=97 Participants
Oral lapatinib (1500 milligrams \[mg\] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared \[mg/m\^2\]) intravenous (IV) for an additional 12 weeks
|
Trastuzumab 2 mg/kg
n=93 Participants
Trastuzumab (4 mg/kilograms \[kg\] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
n=91 Participants
Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
|---|---|---|---|
|
Ratio (95% CI) of Geometric Means in p95HER2 Expression in HR Positive Patients With pCR vs no pCR
|
1.0 Ratio
Interval 0.5 to 1.87
|
1.6 Ratio
Interval 1.0 to 2.71
|
2.1 Ratio
Interval 1.2 to 3.7
|
SECONDARY outcome
Timeframe: Measurement performed at one or more of the time points: baseline, week 2 or week 18Population: Translational Data Set. Note that evaluable samples were not available for all participants.
Circulating tumor cells (CTCs) are cells that have detached from a primary tumor and circulate in the bloodstream. In the adjuvant phase, after surgery all participants received 3 courses of adjuvant 5-fluorouracil, epirubicin and cyclophosphamide, followed by lapatinib 1500 mg or trastuzumab 2 mg/kg or lapatinib 1000/750 mg plus trastuzumab 2 mg/kg given prior to surgery in the neoadjuvant setting for an additional 34 weeks.
Outcome measures
| Measure |
Lapatinib 1500 mg
n=19 Participants
Oral lapatinib (1500 milligrams \[mg\] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared \[mg/m\^2\]) intravenous (IV) for an additional 12 weeks
|
Trastuzumab 2 mg/kg
n=12 Participants
Trastuzumab (4 mg/kilograms \[kg\] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
n=20 Participants
Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
|---|---|---|---|
|
Percentage of Participants With Circulating Tumor Cells (CTC) in the Bloodstream
|
21 Percentage of Participants
|
17 Percentage of Participants
|
25 Percentage of Participants
|
POST_HOC outcome
Timeframe: on-treatment: up to week 31; post-treatment: up to year 10Population: Safety population (for on-treatment deaths) and ITT (for total deaths)
On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, which was approximately 31 weeks. Deaths post treatment survival follow up were collected after the on treatment period, up to 10 years.
Outcome measures
| Measure |
Lapatinib 1500 mg
n=154 Participants
Oral lapatinib (1500 milligrams \[mg\] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared \[mg/m\^2\]) intravenous (IV) for an additional 12 weeks
|
Trastuzumab 2 mg/kg
n=149 Participants
Trastuzumab (4 mg/kilograms \[kg\] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
n=152 Participants
Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
|---|---|---|---|
|
All Collected Deaths
Total Deaths
|
31 Participants
|
32 Participants
|
26 Participants
|
|
All Collected Deaths
On-Treatment Deaths (n=151,148,149)
|
2 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
Serious events: 61 serious events
Other events: 147 other events
Deaths: 1 deaths
Lapatinib 1500 mg
Serious events: 58 serious events
Other events: 148 other events
Deaths: 2 deaths
Trastuzumab 2 mg/kg
Serious events: 36 serious events
Other events: 141 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
n=149 participants at risk
Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
Lapatinib 1500 mg
n=151 participants at risk
Oral lapatinib (1500 milligrams \[mg\] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared \[mg/m\^2\]) intravenous (IV) for an additional 12 weeks
|
Trastuzumab 2 mg/kg
n=148 participants at risk
Trastuzumab (4 mg/kilograms \[kg\] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
|---|---|---|---|
|
Blood and lymphatic system disorders
AGRANULOCYTOSIS
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
2.0%
3/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.3%
2/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
5.4%
8/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
1.3%
2/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.68%
1/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
9.4%
14/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
8.6%
13/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
10.8%
16/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
2.0%
3/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.68%
1/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Gastrointestinal disorders
DIARRHOEA
|
6.0%
9/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
6.0%
9/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Gastrointestinal disorders
DUODENITIS
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Gastrointestinal disorders
ENTERITIS
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Gastrointestinal disorders
GASTRITIS EROSIVE
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.68%
1/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Gastrointestinal disorders
NAUSEA
|
1.3%
2/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.68%
1/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Gastrointestinal disorders
VOMITING
|
2.0%
3/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.4%
2/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
General disorders
ASTHENIA
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
General disorders
CHEST DISCOMFORT
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
General disorders
CHEST PAIN
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
General disorders
PYREXIA
|
3.4%
5/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.3%
2/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.4%
2/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Hepatobiliary disorders
HEPATITIS ACUTE
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
2.7%
4/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.6%
4/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Hepatobiliary disorders
HYPERTRANSAMINASAEMIA
|
10.1%
15/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
15.2%
23/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.68%
1/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
BACTERIAL SEPSIS
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
BREAST CELLULITIS
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.68%
1/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
CELLULITIS
|
1.3%
2/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.4%
2/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
CELLULITIS STAPHYLOCOCCAL
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
DEVICE RELATED SEPSIS
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
ERYSIPELAS
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
HEPATITIS B
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
HERPES SIMPLEX
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.68%
1/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
MASTITIS
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.3%
2/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
PHARYNGITIS
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
PNEUMONIA
|
1.3%
2/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.4%
2/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
SKIN INFECTION
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
VASCULAR DEVICE INFECTION
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
WOUND INFECTION
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Injury, poisoning and procedural complications
ACCIDENTAL OVERDOSE
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.68%
1/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Injury, poisoning and procedural complications
LUMBAR VERTEBRAL FRACTURE
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Injury, poisoning and procedural complications
POISONING
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Injury, poisoning and procedural complications
SEROMA
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.68%
1/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Injury, poisoning and procedural complications
SPINAL FRACTURE
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Injury, poisoning and procedural complications
TOXICITY TO VARIOUS AGENTS
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Injury, poisoning and procedural complications
TRANSFUSION REACTION
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.3%
2/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.68%
1/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Metabolism and nutrition disorders
HYPERPHOSPHATASAEMIA
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROTIC FRACTURE
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SYNDROME
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.68%
1/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LOBULAR BREAST CARCINOMA IN SITU
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE LEIOMYOMA
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.68%
1/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Nervous system disorders
SCIATICA
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
1.3%
2/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Renal and urinary disorders
NEPHRECTASIA
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Reproductive system and breast disorders
METRORRHAGIA
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.68%
1/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Reproductive system and breast disorders
VULVOVAGINAL PRURITUS
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
1.3%
2/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
ORGANISING PNEUMONIA
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Skin and subcutaneous tissue disorders
BLISTER
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Vascular disorders
JUGULAR VEIN THROMBOSIS
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.68%
1/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
Other adverse events
| Measure |
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
n=149 participants at risk
Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
Lapatinib 1500 mg
n=151 participants at risk
Oral lapatinib (1500 milligrams \[mg\] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared \[mg/m\^2\]) intravenous (IV) for an additional 12 weeks
|
Trastuzumab 2 mg/kg
n=148 participants at risk
Trastuzumab (4 mg/kilograms \[kg\] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks
|
|---|---|---|---|
|
Nervous system disorders
HEADACHE
|
20.8%
31/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
17.9%
27/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
17.6%
26/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Nervous system disorders
HYPOAESTHESIA
|
6.0%
9/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
4.6%
7/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
8.1%
12/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
24.2%
36/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
21.9%
33/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
18.2%
27/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
2.0%
3/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.68%
1/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
14.1%
21/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
11.9%
18/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
6.8%
10/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
3.4%
5/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.3%
2/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
4.1%
6/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
31.5%
47/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
33.8%
51/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
25.0%
37/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
2.7%
4/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.3%
2/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.68%
1/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
2.0%
3/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.68%
1/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Cardiac disorders
LEFT VENTRICULAR DYSFUNCTION
|
2.7%
4/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.4%
2/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Cardiac disorders
PALPITATIONS
|
4.0%
6/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
4.0%
6/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Cardiac disorders
TACHYCARDIA
|
2.7%
4/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.3%
2/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.7%
4/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Ear and labyrinth disorders
EAR PAIN
|
2.0%
3/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.68%
1/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Ear and labyrinth disorders
TINNITUS
|
4.0%
6/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Ear and labyrinth disorders
VERTIGO
|
7.4%
11/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
4.6%
7/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
4.1%
6/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Eye disorders
DRY EYE
|
2.7%
4/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.4%
2/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Eye disorders
LACRIMATION INCREASED
|
2.0%
3/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.68%
1/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Eye disorders
VISUAL IMPAIRMENT
|
1.3%
2/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.3%
2/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
2.0%
3/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.7%
4/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
6.7%
10/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
5.3%
8/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
3.4%
5/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
14.1%
21/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
18.5%
28/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
8.8%
13/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
15.4%
23/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
17.9%
27/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
10.8%
16/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Gastrointestinal disorders
ANAL INFLAMMATION
|
2.7%
4/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.3%
2/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.68%
1/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Gastrointestinal disorders
CONSTIPATION
|
12.1%
18/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
9.9%
15/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
10.1%
15/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Gastrointestinal disorders
DIARRHOEA
|
85.9%
128/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
81.5%
123/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
35.1%
52/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Gastrointestinal disorders
DRY MOUTH
|
6.0%
9/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
3.3%
5/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
11.4%
17/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
17.2%
26/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
6.8%
10/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
2.0%
3/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Gastrointestinal disorders
EPIGASTRIC DISCOMFORT
|
2.0%
3/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.3%
2/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.4%
2/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Gastrointestinal disorders
FLATULENCE
|
2.0%
3/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
3.3%
5/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.4%
2/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Gastrointestinal disorders
GASTRITIS
|
1.3%
2/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
5.3%
8/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
3.4%
5/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.3%
2/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
8.7%
13/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
6.6%
10/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
6.8%
10/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
8.1%
12/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.6%
4/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.68%
1/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Gastrointestinal disorders
NAUSEA
|
50.3%
75/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
53.6%
81/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
51.4%
76/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
2.7%
4/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.3%
2/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Gastrointestinal disorders
STOMATITIS
|
18.1%
27/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
11.9%
18/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
15.5%
23/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Gastrointestinal disorders
TOOTHACHE
|
2.7%
4/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.4%
2/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Gastrointestinal disorders
VOMITING
|
36.2%
54/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
37.7%
57/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
25.7%
38/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
General disorders
ASTHENIA
|
26.2%
39/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
31.1%
47/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
23.6%
35/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
General disorders
AXILLARY PAIN
|
3.4%
5/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
General disorders
CHEST DISCOMFORT
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
4.1%
6/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
General disorders
CHEST PAIN
|
3.4%
5/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
3.3%
5/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
4.1%
6/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
General disorders
CHILLS
|
7.4%
11/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
4.1%
6/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
General disorders
FACE OEDEMA
|
2.0%
3/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
3.3%
5/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.7%
4/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
General disorders
FATIGUE
|
34.9%
52/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
29.8%
45/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
25.7%
38/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
General disorders
FEELING COLD
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
General disorders
GENERALISED OEDEMA
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
2.0%
3/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.3%
2/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.4%
2/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
General disorders
MUCOSAL DRYNESS
|
2.0%
3/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.3%
2/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.4%
2/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
General disorders
MUCOSAL EROSION
|
2.0%
3/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
General disorders
MUCOSAL INFLAMMATION
|
24.2%
36/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
22.5%
34/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
14.9%
22/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
General disorders
OEDEMA
|
2.7%
4/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
7.4%
11/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
General disorders
OEDEMA PERIPHERAL
|
5.4%
8/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
6.0%
9/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
8.8%
13/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
General disorders
PAIN
|
2.0%
3/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
4.0%
6/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.4%
2/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
General disorders
PERIPHERAL SWELLING
|
2.7%
4/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.3%
2/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
General disorders
PYREXIA
|
22.8%
34/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
15.2%
23/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
15.5%
23/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
14.1%
21/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
17.2%
26/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
4.7%
7/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Hepatobiliary disorders
HYPERTRANSAMINASAEMIA
|
36.9%
55/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
36.4%
55/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
26.4%
39/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Immune system disorders
HYPERSENSITIVITY
|
4.0%
6/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
4.0%
6/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
4.7%
7/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Immune system disorders
SEASONAL ALLERGY
|
2.0%
3/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
BRONCHITIS
|
1.3%
2/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
3.3%
5/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
CONJUNCTIVITIS
|
7.4%
11/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
5.3%
8/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
3.4%
5/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
CYSTITIS
|
5.4%
8/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
4.0%
6/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
HERPES SIMPLEX
|
2.0%
3/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.4%
2/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
INFLUENZA
|
5.4%
8/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
5.3%
8/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
6.1%
9/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
LOCALISED INFECTION
|
2.0%
3/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
2.0%
3/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.68%
1/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
MASTITIS
|
1.3%
2/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
NAIL INFECTION
|
5.4%
8/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
NASOPHARYNGITIS
|
7.4%
11/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
7.9%
12/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
7.4%
11/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
ORAL HERPES
|
1.3%
2/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
PARONYCHIA
|
11.4%
17/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
9.3%
14/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.4%
2/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
PHARYNGITIS
|
2.7%
4/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
4.6%
7/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
3.4%
5/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
PUSTULE
|
2.0%
3/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.68%
1/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
RHINITIS
|
4.0%
6/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.6%
4/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
3.4%
5/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
SINUSITIS
|
2.0%
3/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
3.3%
5/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.4%
2/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
SKIN INFECTION
|
2.7%
4/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.4%
2/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
TONSILLITIS
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.7%
4/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
6.7%
10/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
6.0%
9/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
9.5%
14/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
7.4%
11/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
9.3%
14/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
4.1%
6/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
VAGINAL INFECTION
|
3.4%
5/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.4%
2/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Injury, poisoning and procedural complications
RADIATION SKIN INJURY
|
10.7%
16/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
7.3%
11/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
12.2%
18/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Injury, poisoning and procedural complications
SEROMA
|
1.3%
2/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
4.1%
6/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
2.0%
3/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.68%
1/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Injury, poisoning and procedural complications
WOUND COMPLICATION
|
2.7%
4/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.6%
4/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
4.1%
6/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Investigations
EJECTION FRACTION DECREASED
|
4.0%
6/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.3%
2/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.7%
4/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE
|
2.0%
3/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.3%
2/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
2.0%
3/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
4.6%
7/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.68%
1/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Investigations
NEUTROPHIL COUNT INCREASED
|
2.0%
3/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.4%
2/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Investigations
WEIGHT DECREASED
|
5.4%
8/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
6.6%
10/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.68%
1/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Investigations
WEIGHT INCREASED
|
1.3%
2/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.3%
2/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
23.5%
35/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
25.8%
39/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
11.5%
17/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
3.3%
5/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
2.0%
3/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.7%
4/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Metabolism and nutrition disorders
HYPERPHOSPHATASAEMIA
|
14.8%
22/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
14.6%
22/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
8.1%
12/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
2.7%
4/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
18.1%
27/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
17.2%
26/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
21.6%
32/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
14.8%
22/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
6.6%
10/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
9.5%
14/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
6.7%
10/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
7.9%
12/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
12.2%
18/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Musculoskeletal and connective tissue disorders
JOINT STIFFNESS
|
1.3%
2/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.7%
4/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
4.0%
6/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.6%
4/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
2.7%
4/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.3%
2/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.68%
1/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
5.4%
8/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
10.6%
16/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
7.4%
11/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL STIFFNESS
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
20.8%
31/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
21.9%
33/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
23.0%
34/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
4.7%
7/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
3.3%
5/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
3.4%
5/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
8.7%
13/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
13.2%
20/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
8.8%
13/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Nervous system disorders
AGEUSIA
|
2.7%
4/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Nervous system disorders
DIZZINESS
|
8.7%
13/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
8.6%
13/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
10.1%
15/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Nervous system disorders
DYSGEUSIA
|
4.0%
6/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
4.0%
6/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.68%
1/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
1.3%
2/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.6%
4/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.4%
2/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
12.8%
19/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
13.9%
21/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
12.8%
19/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Nervous system disorders
NEUROTOXICITY
|
2.0%
3/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
4.0%
6/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Nervous system disorders
PARAESTHESIA
|
16.1%
24/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
9.9%
15/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
14.9%
22/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
8.7%
13/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
12.6%
19/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
9.5%
14/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Nervous system disorders
POLYNEUROPATHY
|
3.4%
5/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Nervous system disorders
TASTE DISORDER
|
6.0%
9/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
4.0%
6/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.68%
1/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Psychiatric disorders
ANXIETY
|
4.7%
7/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
6.0%
9/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
7.4%
11/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Psychiatric disorders
DEPRESSION
|
4.7%
7/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
3.3%
5/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
6.1%
9/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Skin and subcutaneous tissue disorders
ACNE
|
14.8%
22/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
13.2%
20/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
3.4%
5/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Psychiatric disorders
INSOMNIA
|
22.8%
34/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
15.2%
23/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
16.2%
24/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Psychiatric disorders
SLEEP DISORDER
|
3.4%
5/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.6%
4/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.4%
2/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Renal and urinary disorders
DYSURIA
|
7.4%
11/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
4.0%
6/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
3.4%
5/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
63.8%
95/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
59.6%
90/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
64.9%
96/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Renal and urinary disorders
HAEMATURIA
|
2.7%
4/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Reproductive system and breast disorders
AMENORRHOEA
|
4.0%
6/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.68%
1/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Reproductive system and breast disorders
BREAST DISCHARGE
|
2.0%
3/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Reproductive system and breast disorders
BREAST PAIN
|
4.0%
6/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
3.3%
5/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
10.1%
15/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Reproductive system and breast disorders
MENSTRUATION IRREGULAR
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.3%
2/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Reproductive system and breast disorders
PELVIC PAIN
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.7%
4/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Reproductive system and breast disorders
VULVOVAGINAL DRYNESS
|
1.3%
2/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.3%
2/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Reproductive system and breast disorders
VULVOVAGINAL INFLAMMATION
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.6%
4/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Reproductive system and breast disorders
VULVOVAGINAL PRURITUS
|
1.3%
2/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.3%
2/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.7%
4/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
16.8%
25/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
11.3%
17/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
17.6%
26/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
3.3%
5/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.4%
2/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
10.7%
16/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
7.3%
11/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
8.8%
13/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
4.0%
6/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.3%
2/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
4.1%
6/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
24.8%
37/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
19.9%
30/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
14.9%
22/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.00%
0/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL DRYNESS
|
4.0%
6/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
4.0%
6/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.4%
2/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL INFLAMMATION
|
3.4%
5/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.68%
1/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
10.7%
16/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
13.2%
20/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
10.1%
15/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
2.0%
3/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
8.7%
13/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
4.0%
6/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
6.8%
10/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
8.7%
13/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
8.6%
13/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
5.4%
8/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
9.4%
14/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
7.9%
12/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.7%
4/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
18.8%
28/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
19.2%
29/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
5.4%
8/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
4.0%
6/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.6%
4/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.4%
2/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
9.4%
14/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
9.3%
14/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
10.1%
15/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Skin and subcutaneous tissue disorders
EXFOLIATIVE RASH
|
5.4%
8/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.6%
4/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
1.3%
2/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Skin and subcutaneous tissue disorders
NAIL DISORDER
|
24.2%
36/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
17.2%
26/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
12.2%
18/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Skin and subcutaneous tissue disorders
NAIL DYSTROPHY
|
2.0%
3/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.3%
2/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.68%
1/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Skin and subcutaneous tissue disorders
ONYCHALGIA
|
2.0%
3/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.68%
1/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Skin and subcutaneous tissue disorders
ONYCHOLYSIS
|
4.7%
7/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.4%
2/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Skin and subcutaneous tissue disorders
PAIN OF SKIN
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.6%
4/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.4%
2/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
9.4%
14/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
9.3%
14/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
16.1%
24/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
19.2%
29/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
6.1%
9/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Skin and subcutaneous tissue disorders
RASH
|
45.0%
67/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
45.0%
68/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
18.9%
28/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Skin and subcutaneous tissue disorders
RASH PRURITIC
|
2.7%
4/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Skin and subcutaneous tissue disorders
SCAR PAIN
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.7%
4/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Skin and subcutaneous tissue disorders
SKIN EXFOLIATION
|
2.7%
4/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.68%
1/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Skin and subcutaneous tissue disorders
SKIN FISSURES
|
8.7%
13/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.6%
4/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.7%
4/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Skin and subcutaneous tissue disorders
SKIN HYPERPIGMENTATION
|
4.0%
6/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
4.0%
6/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.4%
2/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Skin and subcutaneous tissue disorders
SKIN IRRITATION
|
2.0%
3/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.68%
1/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Skin and subcutaneous tissue disorders
SKIN LESION
|
3.4%
5/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Skin and subcutaneous tissue disorders
SKIN REACTION
|
1.3%
2/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.6%
4/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.00%
0/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Vascular disorders
FLUSHING
|
0.67%
1/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
4.1%
6/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Vascular disorders
HAEMATOMA
|
2.0%
3/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.66%
1/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
0.68%
1/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Vascular disorders
HOT FLUSH
|
14.8%
22/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
9.9%
15/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
14.2%
21/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Vascular disorders
HYPERTENSION
|
3.4%
5/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
3.3%
5/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
5.4%
8/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Vascular disorders
HYPOTENSION
|
5.4%
8/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
3.3%
5/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
1.4%
2/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Vascular disorders
LYMPHOEDEMA
|
2.0%
3/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
3.3%
5/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
|
Vascular disorders
PHLEBITIS
|
1.3%
2/149 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
2.0%
3/151 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
3.4%
5/148 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety
- Publication restrictions are in place
Restriction type: OTHER