Trial Outcomes & Findings for 6 Weeks Treatment of Locally Advanced Breast Cancer With BIBW 2992 (Afatinib) or Lapatinib or Trastuzumab (NCT NCT00826267)
NCT ID: NCT00826267
Last Updated: 2013-12-31
Results Overview
Objective response (complete or partial) was assessed according to RECIST 1.0 criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
Tumour assessments were performed at screening, day 22 and day 43.
Results posted on
2013-12-31
Participant Flow
Because of slow enrollment and a high screen-failure rate, recruitment became a challenge and the sponsor chose to terminate the trial prior to reaching the target enrollment of 120 patients.
Participant milestones
| Measure |
Afatinib 50 mg
Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
|
Lapatinib 1500 mg
Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
|
Trastuzumab
Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
8
|
11
|
|
Overall Study
COMPLETED
|
9
|
8
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Afatinib 50 mg
Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
|
Lapatinib 1500 mg
Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
|
Trastuzumab
Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
|
|---|---|---|---|
|
Overall Study
Other Adverse Event
|
1
|
0
|
0
|
Baseline Characteristics
6 Weeks Treatment of Locally Advanced Breast Cancer With BIBW 2992 (Afatinib) or Lapatinib or Trastuzumab
Baseline characteristics by cohort
| Measure |
Afatinib 50 mg
n=10 Participants
Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
|
Lapatinib 1500 mg
n=8 Participants
Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
|
Trastuzumab
n=11 Participants
Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.7 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
58.5 years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
44.1 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
50.3 years
STANDARD_DEVIATION 12.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
29 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: Tumour assessments were performed at screening, day 22 and day 43.Population: Treated set (TS). TS consisted of all patients who received at least one dose of study medication.
Objective response (complete or partial) was assessed according to RECIST 1.0 criteria.
Outcome measures
| Measure |
Afatinib 50 mg
n=10 Participants
Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
|
Lapatinib 1500 mg
n=8 Participants
Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
|
Trastuzumab
n=11 Participants
Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
|
|---|---|---|---|
|
Objective Response (OR)
|
80.0 Percentage of participants
Interval 44.4 to 97.5
|
75.0 Percentage of participants
Interval 34.9 to 96.8
|
36.4 Percentage of participants
Interval 10.9 to 69.2
|
SECONDARY outcome
Timeframe: Tumour assessments were performed at screening, day 22 and day 43.Population: TS
CB was defined as CR, PR or stable disease (SD) and was assessed according to RECIST criteria regardless of treatment status.
Outcome measures
| Measure |
Afatinib 50 mg
n=10 Participants
Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
|
Lapatinib 1500 mg
n=8 Participants
Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
|
Trastuzumab
n=11 Participants
Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
|
|---|---|---|---|
|
Number of Participants Who Achieved Clinical Benefit (CB)
|
10 Participants
|
8 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 3 weeks or 6 weeksPopulation: TS
Change was based on the primary lesion only rather that the sum of the target lesions as most patients had only one lesion.
Outcome measures
| Measure |
Afatinib 50 mg
n=10 Participants
Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
|
Lapatinib 1500 mg
n=8 Participants
Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
|
Trastuzumab
n=11 Participants
Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
|
|---|---|---|---|
|
Change From Baseline in the Diameter of the Primary Target Lesion.
|
-27.5 millimeters
Standard Error 5.90
|
-31.0 millimeters
Standard Error 6.63
|
-20.9 millimeters
Standard Error 5.63
|
SECONDARY outcome
Timeframe: Day 7Individual drug plasma concentrations of afatinib after multiple oral administrations at day 7
Outcome measures
| Measure |
Afatinib 50 mg
n=10 Participants
Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
|
Lapatinib 1500 mg
Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
|
Trastuzumab
Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
|
|---|---|---|---|
|
Plasma Concentration of Afatinib
|
32.1 ng/mL
Geometric Coefficient of Variation 43.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening, day 22, day 43Population: TS. The small number of available biomarker samples in this study did not allow for a meaningful statistical analysis.
Changes in the biomarkers (Phospho-MAP-Kinase (MAPK), Total MAPK expression, EGFR, HER2, Phospho-EGFR and -HER2, Proliferation marker (Ki67 and p27), Apoptotic index (cleaved caspase 3), Phosphate and tensin homolog (PTEN), HER2 homodimerisation by HERmark assay and Phospho AKT) from biopsy tissue.
Outcome measures
Outcome data not reported
Adverse Events
Afatinib 50 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Lapatinib 1500 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Trastuzumab
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Afatinib 50 mg
n=10 participants at risk
Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
|
Lapatinib 1500 mg
n=8 participants at risk
Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
|
Trastuzumab
n=11 participants at risk
Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/10 • Up to 28 days following the end-of-treatment visit.
|
12.5%
1/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
Blood and lymphatic system disorders
Lymphatic disorder
|
0.00%
0/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
9.1%
1/11 • Up to 28 days following the end-of-treatment visit.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/10 • Up to 28 days following the end-of-treatment visit.
|
25.0%
2/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
Cardiac disorders
Cyanosis
|
0.00%
0/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
9.1%
1/11 • Up to 28 days following the end-of-treatment visit.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
9.1%
1/11 • Up to 28 days following the end-of-treatment visit.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
9.1%
1/11 • Up to 28 days following the end-of-treatment visit.
|
|
Eye disorders
Vision blurred
|
0.00%
0/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
9.1%
1/11 • Up to 28 days following the end-of-treatment visit.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
9.1%
1/11 • Up to 28 days following the end-of-treatment visit.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/10 • Up to 28 days following the end-of-treatment visit.
|
12.5%
1/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • Up to 28 days following the end-of-treatment visit.
|
12.5%
1/8 • Up to 28 days following the end-of-treatment visit.
|
9.1%
1/11 • Up to 28 days following the end-of-treatment visit.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
9.1%
1/11 • Up to 28 days following the end-of-treatment visit.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
18.2%
2/11 • Up to 28 days following the end-of-treatment visit.
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
10/10 • Up to 28 days following the end-of-treatment visit.
|
37.5%
3/8 • Up to 28 days following the end-of-treatment visit.
|
9.1%
1/11 • Up to 28 days following the end-of-treatment visit.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/10 • Up to 28 days following the end-of-treatment visit.
|
25.0%
2/8 • Up to 28 days following the end-of-treatment visit.
|
9.1%
1/11 • Up to 28 days following the end-of-treatment visit.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
9.1%
1/11 • Up to 28 days following the end-of-treatment visit.
|
|
Gastrointestinal disorders
Lip dry
|
10.0%
1/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Up to 28 days following the end-of-treatment visit.
|
25.0%
2/8 • Up to 28 days following the end-of-treatment visit.
|
27.3%
3/11 • Up to 28 days following the end-of-treatment visit.
|
|
Gastrointestinal disorders
Oral discomfort
|
10.0%
1/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
9.1%
1/11 • Up to 28 days following the end-of-treatment visit.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
9.1%
1/11 • Up to 28 days following the end-of-treatment visit.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/10 • Up to 28 days following the end-of-treatment visit.
|
12.5%
1/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
18.2%
2/11 • Up to 28 days following the end-of-treatment visit.
|
|
General disorders
Asthenia
|
0.00%
0/10 • Up to 28 days following the end-of-treatment visit.
|
12.5%
1/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
General disorders
Chills
|
0.00%
0/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
18.2%
2/11 • Up to 28 days following the end-of-treatment visit.
|
|
General disorders
Fatigue
|
0.00%
0/10 • Up to 28 days following the end-of-treatment visit.
|
12.5%
1/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
General disorders
Influenza like illness
|
0.00%
0/10 • Up to 28 days following the end-of-treatment visit.
|
12.5%
1/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
General disorders
Mucosal inflammation
|
40.0%
4/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
9.1%
1/11 • Up to 28 days following the end-of-treatment visit.
|
|
General disorders
Pain
|
0.00%
0/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
9.1%
1/11 • Up to 28 days following the end-of-treatment visit.
|
|
General disorders
Pyrexia
|
10.0%
1/10 • Up to 28 days following the end-of-treatment visit.
|
12.5%
1/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
Infections and infestations
Ear infection
|
10.0%
1/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
Infections and infestations
Fungal infection
|
10.0%
1/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
1/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
Infections and infestations
Oral candidiasis
|
10.0%
1/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
Infections and infestations
Paronychia
|
50.0%
5/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
Infections and infestations
Rash pustular
|
10.0%
1/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
Infections and infestations
Respiratory tract infection
|
10.0%
1/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
Infections and infestations
Skin infection
|
10.0%
1/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
Infections and infestations
Viral sinusitis
|
10.0%
1/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
10.0%
1/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
1/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
Investigations
Blood creatine phosphokinase increased
|
10.0%
1/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
Investigations
Weight decreased
|
0.00%
0/10 • Up to 28 days following the end-of-treatment visit.
|
12.5%
1/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
20.0%
2/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
36.4%
4/11 • Up to 28 days following the end-of-treatment visit.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
9.1%
1/11 • Up to 28 days following the end-of-treatment visit.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
18.2%
2/11 • Up to 28 days following the end-of-treatment visit.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
18.2%
2/11 • Up to 28 days following the end-of-treatment visit.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
9.1%
1/11 • Up to 28 days following the end-of-treatment visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/10 • Up to 28 days following the end-of-treatment visit.
|
12.5%
1/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
Nervous system disorders
Headache
|
20.0%
2/10 • Up to 28 days following the end-of-treatment visit.
|
12.5%
1/8 • Up to 28 days following the end-of-treatment visit.
|
36.4%
4/11 • Up to 28 days following the end-of-treatment visit.
|
|
Nervous system disorders
Tremor
|
0.00%
0/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
9.1%
1/11 • Up to 28 days following the end-of-treatment visit.
|
|
Renal and urinary disorders
Dysuria
|
10.0%
1/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
Renal and urinary disorders
Haematuria
|
10.0%
1/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
Renal and urinary disorders
Urinary retention
|
10.0%
1/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.00%
0/10 • Up to 28 days following the end-of-treatment visit.
|
12.5%
1/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
9.1%
1/11 • Up to 28 days following the end-of-treatment visit.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/10 • Up to 28 days following the end-of-treatment visit.
|
12.5%
1/8 • Up to 28 days following the end-of-treatment visit.
|
9.1%
1/11 • Up to 28 days following the end-of-treatment visit.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/10 • Up to 28 days following the end-of-treatment visit.
|
12.5%
1/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
10.0%
1/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
10.0%
1/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
9.1%
1/11 • Up to 28 days following the end-of-treatment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
9.1%
1/11 • Up to 28 days following the end-of-treatment visit.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
9.1%
1/11 • Up to 28 days following the end-of-treatment visit.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
60.0%
6/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
10.0%
1/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
9.1%
1/11 • Up to 28 days following the end-of-treatment visit.
|
|
Skin and subcutaneous tissue disorders
Excessive granulation tissue
|
10.0%
1/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
Skin and subcutaneous tissue disorders
Rash
|
30.0%
3/10 • Up to 28 days following the end-of-treatment visit.
|
12.5%
1/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
10.0%
1/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
Skin and subcutaneous tissue disorders
Rash follicular
|
10.0%
1/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
10.0%
1/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/11 • Up to 28 days following the end-of-treatment visit.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
9.1%
1/11 • Up to 28 days following the end-of-treatment visit.
|
|
Vascular disorders
Hypertension
|
0.00%
0/10 • Up to 28 days following the end-of-treatment visit.
|
0.00%
0/8 • Up to 28 days following the end-of-treatment visit.
|
9.1%
1/11 • Up to 28 days following the end-of-treatment visit.
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER