Trial Outcomes & Findings for LUX-Head & Neck 4: Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy (NCT NCT02131155)
NCT ID: NCT02131155
Last Updated: 2019-03-01
Results Overview
DFS, defined as the number of days from the date of randomisation to the date of tumour recurrence/ Second Primary Tumours (SPT) or death from any cause, whichever occurred first. For patients with known date of tumour recurrence/SPT (or death), the event date was the date of tumour recurrence/SPT or the date of death, whichever came first, i.e. DFS \[day\] = minimum (date of tumour recurrence/SPT, date of death) - date of randomisation +1. For patients known to be alive and without tumour recurrence/SPT by the end of trial or follow-up visit, they were censored at the date of last imaging when the patient was known to be disease-free and alive: DFS (censored) \[days\] = date of last imaging when the patient was known to be diseasefree and alive - date of randomisation + 1. The Kaplan-Meier (KM) method was to be used to estimate the median DFS for each treatment group. 95% confidence interval (CI) was to be constructed using the Greenwood variance estimate.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
36 participants
Primary outcome timeframe
up to 4 years
Results posted on
2019-03-01
Participant Flow
Participant milestones
| Measure |
Afatinib (BIBW2992)
Afatinib (BIBW2992) is a film coated tablet. Patients were administered single daily dose of afatinib, starting at 40 milligram (mg) orally with water (\~250 millilitre) up to a period of 80 weeks. The dose had to be escalated to 50 mg and/or reduced to 40 mg, 30 mg, or 20 mg.
|
Placebo
Single daily dose of matching placebo available for the 50 mg, 40 mg, 30 mg and 20 mg afatinib tablets were administered orally with water (\~250 millilitre) up to a period of 80 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
11
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
25
|
11
|
Reasons for withdrawal
| Measure |
Afatinib (BIBW2992)
Afatinib (BIBW2992) is a film coated tablet. Patients were administered single daily dose of afatinib, starting at 40 milligram (mg) orally with water (\~250 millilitre) up to a period of 80 weeks. The dose had to be escalated to 50 mg and/or reduced to 40 mg, 30 mg, or 20 mg.
|
Placebo
Single daily dose of matching placebo available for the 50 mg, 40 mg, 30 mg and 20 mg afatinib tablets were administered orally with water (\~250 millilitre) up to a period of 80 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Treatment completed
|
1
|
0
|
|
Overall Study
Primary tumour recurrence
|
2
|
1
|
|
Overall Study
Refused to continue study medication
|
1
|
0
|
|
Overall Study
Study early termination
|
20
|
10
|
Baseline Characteristics
LUX-Head & Neck 4: Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy
Baseline characteristics by cohort
| Measure |
Afatinib (BIBW2992)
n=25 Participants
Afatinib (BIBW2992) is a film coated tablet. Patients were administered single daily dose of afatinib, starting at 40 milligram (mg) orally with water (\~250 millilitre) up to a period of 80 weeks. The dose had to be escalated to 50 mg and/or reduced to 40 mg, 30 mg, or 20 mg.
|
Placebo
n=11 Participants
Single daily dose of matching placebo available for the 50 mg, 40 mg, 30 mg and 20 mg afatinib tablets were administered orally with water (\~250 millilitre) up to a period of 80 weeks.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.4 Years
STANDARD_DEVIATION 9.70 • n=5 Participants
|
58.4 Years
STANDARD_DEVIATION 6.27 • n=7 Participants
|
56.3 Years
STANDARD_DEVIATION 8.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 4 yearsPopulation: Randomised Set; This study was early terminated and data was available for less than 2/3rds of participants hence per internal Boehringer Ingelheim rules the analysis was not performed as planned in protocol.
DFS, defined as the number of days from the date of randomisation to the date of tumour recurrence/ Second Primary Tumours (SPT) or death from any cause, whichever occurred first. For patients with known date of tumour recurrence/SPT (or death), the event date was the date of tumour recurrence/SPT or the date of death, whichever came first, i.e. DFS \[day\] = minimum (date of tumour recurrence/SPT, date of death) - date of randomisation +1. For patients known to be alive and without tumour recurrence/SPT by the end of trial or follow-up visit, they were censored at the date of last imaging when the patient was known to be disease-free and alive: DFS (censored) \[days\] = date of last imaging when the patient was known to be diseasefree and alive - date of randomisation + 1. The Kaplan-Meier (KM) method was to be used to estimate the median DFS for each treatment group. 95% confidence interval (CI) was to be constructed using the Greenwood variance estimate.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: Randomised Set; This study was early terminated and data was available for less than 2/3rds of participants hence per internal Boehringer Ingelheim rules the analysis was not performed as planned in protocol.
Disease Free Survival (DFS) rate at 2 years is presented
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 4 yearsPopulation: Randomised Set; This study was early terminated and data was available for less than 2/3rds of participants hence per internal Boehringer Ingelheim rules the analysis was not performed as planned in protocol.
OS was defined as time from the date of randomisation until death. For patients with known date of death (regardless of the cause of death): OS \[days\] = date of death - date of randomisation +1 For patients known to be alive by the end of trial: OS (censored) \[days\] = the last date when the patient was known to be alive - date of randomisation +1 OS was to be analysed similarly to DFS.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 4 yearsPopulation: Randomised Set; This study was early terminated and data was available for less than 2/3rds of participants hence per internal Boehringer Ingelheim rules the analysis was not performed as planned in protocol.
The main analysis of HRQOL questionnaires was to focus on the change in score from baseline in the following scales measured on the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and EORTC QLQ-H\&N35: * Global Health Status/ Quality of Life (QOL) Scale * Pain Scale * Swallowing Scale
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Afatinib (BIBW2992)
Serious events: 5 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=11 participants at risk
Single daily dose of matching placebo available for the 50 mg, 40 mg, 30 mg and 20 mg afatinib tablets were administered orally with water (\~250 millilitre) up to a period of 80 weeks.
|
Afatinib (BIBW2992)
n=25 participants at risk
Afatinib (BIBW2992) is a film coated tablet. Patients were administered single daily dose of afatinib, starting at 40 milligram (mg) orally with water (\~250 millilitre) up to a period of 80 weeks. The dose had to be escalated to 50 mg and/or reduced to 40 mg, 30 mg, or 20 mg.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
4.0%
1/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
4.0%
1/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
4.0%
1/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
4.0%
1/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Infections and infestations
Pharyngitis
|
9.1%
1/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
0.00%
0/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
4.0%
1/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
4.0%
1/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.1%
1/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
0.00%
0/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
4.0%
1/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
9.1%
1/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
0.00%
0/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
Other adverse events
| Measure |
Placebo
n=11 participants at risk
Single daily dose of matching placebo available for the 50 mg, 40 mg, 30 mg and 20 mg afatinib tablets were administered orally with water (\~250 millilitre) up to a period of 80 weeks.
|
Afatinib (BIBW2992)
n=25 participants at risk
Afatinib (BIBW2992) is a film coated tablet. Patients were administered single daily dose of afatinib, starting at 40 milligram (mg) orally with water (\~250 millilitre) up to a period of 80 weeks. The dose had to be escalated to 50 mg and/or reduced to 40 mg, 30 mg, or 20 mg.
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.1%
1/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
8.0%
2/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
9.1%
1/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
0.00%
0/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Eye disorders
Conjunctival haemorrhage
|
9.1%
1/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
0.00%
0/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
8.0%
2/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
8.0%
2/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
1/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
68.0%
17/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
27.3%
3/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
16.0%
4/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
9.1%
1/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
4.0%
1/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
9.1%
1/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
0.00%
0/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Gingival pain
|
9.1%
1/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
0.00%
0/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Oral pain
|
9.1%
1/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
4.0%
1/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
9.1%
1/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
16.0%
4/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
General disorders
Asthenia
|
9.1%
1/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
4.0%
1/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
General disorders
Fatigue
|
0.00%
0/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
8.0%
2/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
General disorders
Localised oedema
|
9.1%
1/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
4.0%
1/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
12.0%
3/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Infections and infestations
Erythrasma
|
9.1%
1/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
0.00%
0/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Infections and infestations
Fungal infection
|
9.1%
1/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
0.00%
0/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Infections and infestations
Herpes zoster
|
9.1%
1/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
0.00%
0/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Infections and infestations
Nasopharyngitis
|
9.1%
1/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
8.0%
2/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Infections and infestations
Paronychia
|
0.00%
0/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
12.0%
3/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Infections and infestations
Periodontitis
|
9.1%
1/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
0.00%
0/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
8.0%
2/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
9.1%
1/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
8.0%
2/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Investigations
Aspartate aminotransferase decreased
|
9.1%
1/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
0.00%
0/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
9.1%
1/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
4.0%
1/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Investigations
Blood creatinine increased
|
9.1%
1/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
0.00%
0/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Investigations
Blood fibrinogen increased
|
9.1%
1/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
8.0%
2/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Investigations
Neutrophil count
|
0.00%
0/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
8.0%
2/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Investigations
Neutrophil count decreased
|
9.1%
1/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
0.00%
0/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Investigations
Reticulocyte count increased
|
0.00%
0/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
8.0%
2/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Investigations
Weight decreased
|
9.1%
1/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
28.0%
7/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Investigations
White blood cell count decreased
|
27.3%
3/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
16.0%
4/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
16.0%
4/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
9.1%
1/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
0.00%
0/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
8.0%
2/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
0.00%
0/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
9.1%
1/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
4.0%
1/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Nervous system disorders
Paraesthesia
|
9.1%
1/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
0.00%
0/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Nervous system disorders
Somnolence
|
9.1%
1/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
0.00%
0/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.2%
2/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
8.0%
2/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
9.1%
1/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
0.00%
0/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
18.2%
2/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
8.0%
2/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal swelling
|
9.1%
1/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
0.00%
0/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
18.2%
2/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
0.00%
0/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
8.0%
2/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
8.0%
2/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
8.0%
2/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
12.0%
3/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
18.2%
2/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
8.0%
2/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Skin and subcutaneous tissue disorders
Nail bed tenderness
|
9.1%
1/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
0.00%
0/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Skin and subcutaneous tissue disorders
Onychalgia
|
9.1%
1/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
0.00%
0/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.1%
1/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
8.0%
2/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.2%
2/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
56.0%
14/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
9.1%
1/11 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
0.00%
0/25 • Up to 4 years
Safety analysis was based on Treated Set (TS): This analysis set included all patients who received at least one dose of investigational treatment.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER