Trial Outcomes & Findings for Lux-Breast 3; Afatinib Alone or in Combination With Vinorelbine in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer Suffering From Brain Metastases (NCT NCT01441596)
NCT ID: NCT01441596
Last Updated: 2015-09-07
Results Overview
Percentage of patients with patient benefit at week 12. Patient benefit was defined by the absence of central nervous system (CNS) disease progression according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 in addition to no tumour-related worsening of the neurological signs and symptoms (NSS), no tumour-related increase in corticosteroid dosage and no progression of extra CNS disease according to RECIST 1.1
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
121 participants
Primary outcome timeframe
12 weeks from randomisation
Results posted on
2015-09-07
Participant Flow
Participant milestones
| Measure |
Afatinib Mono
Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
|
Afatinib+Vino
Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.
|
Investigator's Choice
Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
38
|
43
|
|
Overall Study
COMPLETED
|
36
|
35
|
39
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
4
|
Reasons for withdrawal
| Measure |
Afatinib Mono
Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
|
Afatinib+Vino
Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.
|
Investigator's Choice
Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
|
|---|---|---|---|
|
Overall Study
Other reason not defined below
|
0
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
2
|
|
Overall Study
Not treated
|
0
|
1
|
1
|
Baseline Characteristics
Lux-Breast 3; Afatinib Alone or in Combination With Vinorelbine in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer Suffering From Brain Metastases
Baseline characteristics by cohort
| Measure |
Afatinib Mono
n=40 Participants
Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
|
Afatinib+Vino
n=38 Participants
Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.
|
Investigator's Choice
n=43 Participants
Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.5 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
51.2 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
52.6 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
51.8 years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
121 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weeks from randomisationPopulation: Randomised Set (RS): includes all randomised patients, whether treated or not.
Percentage of patients with patient benefit at week 12. Patient benefit was defined by the absence of central nervous system (CNS) disease progression according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 in addition to no tumour-related worsening of the neurological signs and symptoms (NSS), no tumour-related increase in corticosteroid dosage and no progression of extra CNS disease according to RECIST 1.1
Outcome measures
| Measure |
Afatinib Mono
n=40 Participants
Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
|
Afatinib+Vino
n=38 Participants
Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.
|
Investigator's Choice
n=43 Participants
Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
|
|---|---|---|---|
|
Patient Benefit Rate at 12 Weeks
|
30.0 percentage of participants
Interval 16.6 to 46.5
|
34.2 percentage of participants
Interval 19.6 to 51.4
|
41.9 percentage of participants
Interval 27.0 to 57.9
|
SECONDARY outcome
Timeframe: From first drug administration until 28 days after end of treatment, up to 805 daysPopulation: RS including only patients who experienced disease progression or death
Progression-Free Survival is defined as the time from the date of randomisation to the date of disease progression or death whichever came first. Disease progression was defined as either disease progression in CNS lesions (including worsening in NSS and use of corticosteroid) or disease progression in extra-CNS lesions according to RECIST 1.1.
Outcome measures
| Measure |
Afatinib Mono
n=40 Participants
Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
|
Afatinib+Vino
n=38 Participants
Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.
|
Investigator's Choice
n=43 Participants
Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
|
|---|---|---|---|
|
Progression-Free Survival
|
11.9 weeks
Interval 6.1 to 20.9
|
12.3 weeks
Interval 6.3 to 23.3
|
18.4 weeks
Interval 8.3 to 30.7
|
SECONDARY outcome
Timeframe: From first drug administration until 28 days after end of treatment, up to 805 daysPopulation: RS including only patients who died
Overall Survival is defined as time from randomisation to the date of death from any cause.
Outcome measures
| Measure |
Afatinib Mono
n=40 Participants
Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
|
Afatinib+Vino
n=38 Participants
Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.
|
Investigator's Choice
n=43 Participants
Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
|
|---|---|---|---|
|
Overall Survival
|
57.7 weeks
Interval 34.1 to 81.3
|
37.3 weeks
Interval 21.0 to 66.7
|
52.1 weeks
Interval 29.1 to 122.6
|
Adverse Events
Afatinib Mono
Serious events: 18 serious events
Other events: 39 other events
Deaths: 0 deaths
Afatinib+Vino
Serious events: 24 serious events
Other events: 37 other events
Deaths: 0 deaths
Investigator's Choice
Serious events: 22 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Afatinib Mono
n=40 participants at risk
Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
|
Afatinib+Vino
n=37 participants at risk
Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.
|
Investigator's Choice
n=42 participants at risk
Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.7%
1/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
8.1%
3/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Congenital, familial and genetic disorders
Progressive cerebellar degeneration
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Gastrointestinal disorders
Diarrhoea
|
7.5%
3/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
13.5%
5/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.7%
1/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.7%
1/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.7%
1/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.7%
1/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Gastrointestinal disorders
Nausea
|
2.5%
1/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Gastrointestinal disorders
Stomatitis
|
2.5%
1/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.7%
1/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.7%
1/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Gastrointestinal disorders
Vomiting
|
7.5%
3/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
5.4%
2/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
General disorders
Asthenia
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
5.4%
2/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
General disorders
Chest discomfort
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.7%
1/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
General disorders
Concomitant disease progression
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.7%
1/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
General disorders
Death
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
4.8%
2/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
General disorders
General physical health deterioration
|
10.0%
4/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
16.2%
6/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
General disorders
Generalised oedema
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
General disorders
Mucosal inflammation
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.7%
1/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
General disorders
Pyrexia
|
2.5%
1/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.7%
1/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Infections and infestations
Device related infection
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
5.4%
2/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Infections and infestations
Erysipelas
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Infections and infestations
Infection
|
2.5%
1/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Infections and infestations
Lung infection
|
2.5%
1/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
8.1%
3/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Infections and infestations
Pneumonia
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.7%
1/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.7%
1/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Infections and infestations
Sepsis
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.7%
1/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Infections and infestations
Septic shock
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
5.4%
2/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Infections and infestations
Urinary tract infection
|
2.5%
1/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Infections and infestations
Urosepsis
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.7%
1/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Injury, poisoning and procedural complications
Brain herniation
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.7%
1/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.7%
1/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
5.4%
2/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
2.5%
1/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Investigations
CSF protein increased
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.5%
1/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Metabolism and nutrition disorders
Dehydration
|
2.5%
1/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.7%
1/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.5%
1/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.5%
1/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.7%
1/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Musculoskeletal and connective tissue disorders
Hypercreatinaemia
|
2.5%
1/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
2.5%
1/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
2.5%
1/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
4.8%
2/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.7%
1/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.7%
1/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Nervous system disorders
Convulsion
|
5.0%
2/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
8.1%
3/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
7.1%
3/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Nervous system disorders
Dizziness
|
2.5%
1/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
5.4%
2/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Nervous system disorders
Epilepsy
|
5.0%
2/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.7%
1/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Nervous system disorders
Headache
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
8.1%
3/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
4.8%
2/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.7%
1/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Nervous system disorders
Hemiplegia
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.7%
1/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Nervous system disorders
Motor dysfunction
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Nervous system disorders
Motor neurone disease
|
2.5%
1/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Nervous system disorders
Neurological symptom
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.7%
1/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Nervous system disorders
Partial seizures
|
2.5%
1/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.7%
1/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Nervous system disorders
Presyncope
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.7%
1/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Nervous system disorders
Somnolence
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Nervous system disorders
Syncope
|
2.5%
1/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Nervous system disorders
Tremor
|
2.5%
1/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
4.8%
2/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Renal and urinary disorders
Renal failure acute
|
2.5%
1/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.7%
1/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.7%
1/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.7%
1/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
Other adverse events
| Measure |
Afatinib Mono
n=40 participants at risk
Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
|
Afatinib+Vino
n=37 participants at risk
Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.
|
Investigator's Choice
n=42 participants at risk
Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.5%
1/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
32.4%
12/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
14.3%
6/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
8.1%
3/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
11.9%
5/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Blood and lymphatic system disorders
Lymphopenia
|
2.5%
1/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
8.1%
3/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
62.2%
23/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
26.2%
11/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Ear and labyrinth disorders
Vertigo
|
2.5%
1/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
16.2%
6/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
21.4%
9/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Eye disorders
Diplopia
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
11.9%
5/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Eye disorders
Dry eye
|
2.5%
1/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
10.8%
4/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
7.1%
3/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Eye disorders
Vision blurred
|
7.5%
3/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
10.8%
4/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
9.5%
4/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Eye disorders
Visual impairment
|
7.5%
3/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
13.5%
5/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
11.9%
5/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Gastrointestinal disorders
Abdominal distension
|
5.0%
2/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
5.4%
2/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
2/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
16.2%
6/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
16.7%
7/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.5%
3/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
5.4%
2/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Gastrointestinal disorders
Constipation
|
20.0%
8/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
27.0%
10/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
33.3%
14/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Gastrointestinal disorders
Diarrhoea
|
90.0%
36/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
83.8%
31/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
38.1%
16/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Gastrointestinal disorders
Dry mouth
|
5.0%
2/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
10.8%
4/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
5/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
5.4%
2/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
4.8%
2/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
8.1%
3/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Gastrointestinal disorders
Haemorrhoids
|
10.0%
4/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.7%
1/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Gastrointestinal disorders
Nausea
|
25.0%
10/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
35.1%
13/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
35.7%
15/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Gastrointestinal disorders
Stomatitis
|
12.5%
5/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
35.1%
13/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
14.3%
6/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Gastrointestinal disorders
Vomiting
|
17.5%
7/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
24.3%
9/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
26.2%
11/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
General disorders
Asthenia
|
27.5%
11/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
24.3%
9/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
33.3%
14/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
General disorders
Fatigue
|
20.0%
8/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
29.7%
11/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
7.1%
3/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
General disorders
Gait disturbance
|
5.0%
2/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
8.1%
3/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
General disorders
Malaise
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
5.4%
2/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
General disorders
Mucosal inflammation
|
20.0%
8/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
29.7%
11/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
14.3%
6/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
General disorders
Oedema peripheral
|
10.0%
4/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
5.4%
2/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
11.9%
5/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
General disorders
Pain
|
2.5%
1/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
8.1%
3/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
4.8%
2/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
General disorders
Pyrexia
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
5.4%
2/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
7.1%
3/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
General disorders
Xerosis
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
5.4%
2/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Infections and infestations
Bronchitis
|
7.5%
3/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.7%
1/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Infections and infestations
Conjunctivitis
|
10.0%
4/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
5.4%
2/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Infections and infestations
Cystitis
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
8.1%
3/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
4.8%
2/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Infections and infestations
Paronychia
|
12.5%
5/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
16.2%
6/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Infections and infestations
Rhinitis
|
2.5%
1/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
5.4%
2/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Infections and infestations
Urinary tract infection
|
5.0%
2/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
21.6%
8/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
14.3%
6/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Injury, poisoning and procedural complications
Fall
|
7.5%
3/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.7%
1/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
7.1%
3/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Investigations
Alanine aminotransferase increased
|
2.5%
1/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
8.1%
3/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Investigations
Aspartate aminotransferase increased
|
5.0%
2/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
5.4%
2/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Investigations
Weight decreased
|
5.0%
2/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
8.1%
3/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
22.5%
9/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
24.3%
9/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
23.8%
10/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.0%
2/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
8.1%
3/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.0%
4/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
18.9%
7/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
4.8%
2/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
8.1%
3/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
7.1%
3/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.5%
1/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
16.2%
6/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
14.3%
6/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.0%
4/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
8.1%
3/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.5%
1/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.7%
1/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
7.1%
3/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
5.4%
2/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
4.8%
2/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.5%
1/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
10.8%
4/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
14.3%
6/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.5%
1/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
10.8%
4/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
4.8%
2/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Nervous system disorders
Aphasia
|
2.5%
1/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
8.1%
3/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
7.1%
3/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Nervous system disorders
Ataxia
|
5.0%
2/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
8.1%
3/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
9.5%
4/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Nervous system disorders
Balance disorder
|
2.5%
1/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
5.4%
2/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
4.8%
2/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
5.4%
2/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Nervous system disorders
Dizziness
|
20.0%
8/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
24.3%
9/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
28.6%
12/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Nervous system disorders
Dysarthria
|
2.5%
1/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
8.1%
3/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Nervous system disorders
Headache
|
27.5%
11/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
29.7%
11/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
38.1%
16/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
9.5%
4/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Nervous system disorders
Neurotoxicity
|
7.5%
3/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
7.1%
3/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.5%
1/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
5.4%
2/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
7.1%
3/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Nervous system disorders
Somnolence
|
7.5%
3/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
8.1%
3/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Nervous system disorders
Tremor
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.7%
1/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
7.1%
3/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Psychiatric disorders
Anxiety
|
5.0%
2/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
5.4%
2/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
4.8%
2/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Psychiatric disorders
Depression
|
2.5%
1/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
5.4%
2/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Psychiatric disorders
Insomnia
|
15.0%
6/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
13.5%
5/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
9.5%
4/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Renal and urinary disorders
Dysuria
|
2.5%
1/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
8.1%
3/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
5.4%
2/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.5%
3/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
10.8%
4/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
4.8%
2/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
2/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
8.1%
3/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
9.5%
4/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
5/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
18.9%
7/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
7.1%
3/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.0%
2/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
8.1%
3/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
7.1%
3/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
8.1%
3/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
19.0%
8/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
20.0%
8/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
5.4%
2/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.0%
8/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
13.5%
5/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
5.0%
2/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
5.4%
2/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
4.8%
2/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
0.00%
0/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
5.4%
2/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
15.0%
6/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
16.7%
7/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.5%
3/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.7%
1/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
2.4%
1/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
37.5%
15/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
54.1%
20/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
9.5%
4/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
7.5%
3/40 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/37 • From first drug administration until 28 days after end of treatment, up to 805 days
|
0.00%
0/42 • From first drug administration until 28 days after end of treatment, up to 805 days
|
Additional Information
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Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Other - Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
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Restriction type: OTHER