Trial Outcomes & Findings for BIBW2992 (Afatinib) in Advanced (EGFR-FISH +) NSCLC (Non Small Cell Lung Cancer) Patients (NCT NCT00796549)
NCT ID: NCT00796549
Last Updated: 2014-07-22
Results Overview
Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12.
Results posted on
2014-07-22
Participant Flow
First patient enrolled on December 23rd 2008 . Last patient enrolled on September 1st 2011. Patients were recruited in Oncology departments of Italian investigational sites
Participant milestones
| Measure |
Afatinib 50mg
Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
|
|---|---|
|
Overall Study
STARTED
|
218
|
|
Overall Study
Entered
|
69
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
218
|
Reasons for withdrawal
| Measure |
Afatinib 50mg
Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
|
|---|---|
|
Overall Study
Adverse Event
|
11
|
|
Overall Study
not entered
|
149
|
|
Overall Study
Other
|
2
|
|
Overall Study
Progressive disease
|
56
|
Baseline Characteristics
BIBW2992 (Afatinib) in Advanced (EGFR-FISH +) NSCLC (Non Small Cell Lung Cancer) Patients
Baseline characteristics by cohort
| Measure |
Afatinib 50mg
n=69 Participants
Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
|
|---|---|
|
Age, Continuous
|
63.8 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12.Population: Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.
Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0.
Outcome measures
| Measure |
Afatinib 50mg
n=69 Participants
Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
|
Afatinib 50mg 2nd Line
Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors). Only Patients with 2nd line anti cancer treatment, indicating that they had received one prior anti cancer treatment with chemotherapy.
|
|---|---|---|
|
Percentage of Participants With Best Objective Response
|
13.0 percentage of participants
Interval 6.1 to 23.3
|
—
|
SECONDARY outcome
Timeframe: Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12.Population: Treated set (TS).
Cumulative number of participants with objective response by time points with responders.
Outcome measures
| Measure |
Afatinib 50mg
n=69 Participants
Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
|
Afatinib 50mg 2nd Line
Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors). Only Patients with 2nd line anti cancer treatment, indicating that they had received one prior anti cancer treatment with chemotherapy.
|
|---|---|---|
|
Number of Participants With Objective Response (OR) Categorized by Time
by week 8
|
11.6 percentage of participants
|
—
|
|
Number of Participants With Objective Response (OR) Categorized by Time
by week 96
|
13.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12.Population: Treated set (TS).
Duration of confirmed Objective Response is measured from the time of first Objective Response (OR) to the time of progression or death (or date of censoring for progression free survival).
Outcome measures
| Measure |
Afatinib 50mg
n=69 Participants
Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
|
Afatinib 50mg 2nd Line
Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors). Only Patients with 2nd line anti cancer treatment, indicating that they had received one prior anti cancer treatment with chemotherapy.
|
|---|---|---|
|
Duration of Confirmed Objective Response (OR)
|
45.5 Weeks
Standard Deviation 36.5
|
—
|
SECONDARY outcome
Timeframe: Every 8 weeks until last response assessment 28NOV12Population: Treated set (TS).
Percentage of participants with Objective response (OR) or stable disease (SD) as determined by RECIST version 1.0.
Outcome measures
| Measure |
Afatinib 50mg
n=69 Participants
Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
|
Afatinib 50mg 2nd Line
Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors). Only Patients with 2nd line anti cancer treatment, indicating that they had received one prior anti cancer treatment with chemotherapy.
|
|---|---|---|
|
Percentage of Participants With Disease Control (DC)
|
50.7 percentage of participants
Interval 38.4 to 63.0
|
—
|
SECONDARY outcome
Timeframe: Every 8 weeks until last response assessment 28NOV12Population: Treated set (TS).
Duration of Disease Control is measured from the time of first Objective Response to the time of progression or death (or date of censoring for progression free survival) or respectively for SD as the time from date of randomization to date that disease progression.
Outcome measures
| Measure |
Afatinib 50mg
n=69 Participants
Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
|
Afatinib 50mg 2nd Line
Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors). Only Patients with 2nd line anti cancer treatment, indicating that they had received one prior anti cancer treatment with chemotherapy.
|
|---|---|---|
|
Duration of Confirmed Disease Control
|
37.4 Weeks
Standard Deviation 35.6
|
—
|
SECONDARY outcome
Timeframe: Every 8 weeks until last response assessment 28NOV12Population: Treated set (TS).
Progression Free Survival time defined as time from the start of treatment to the earliest of progression (RECIST), clinical progression (investigator), start of new anti-cancer treatment or death.
Outcome measures
| Measure |
Afatinib 50mg
n=69 Participants
Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
|
Afatinib 50mg 2nd Line
Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors). Only Patients with 2nd line anti cancer treatment, indicating that they had received one prior anti cancer treatment with chemotherapy.
|
|---|---|---|
|
Progression Free Survival (PFS) Time
|
8.43 Weeks
Interval 7.43 to 15.71
|
—
|
SECONDARY outcome
Timeframe: Baseline until last vital status assessment 17JUN13Population: Treated set (TS).
Overall survival time is defined as time from the date of start of treatment to the date of death.
Outcome measures
| Measure |
Afatinib 50mg
n=69 Participants
Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
|
Afatinib 50mg 2nd Line
Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors). Only Patients with 2nd line anti cancer treatment, indicating that they had received one prior anti cancer treatment with chemotherapy.
|
|---|---|---|
|
Overall Survival (OS) Time
|
50.43 Weeks
Interval 33.43 to 64.0
|
—
|
SECONDARY outcome
Timeframe: Day 15Population: Pharmacokinetic set (PK set) contains all patients who received study medication and have evaluable pharmacokinetic parameter data. Data from patients who received the starting dose of 50 mg afatinib and were still on treatment and not dose-reduced on Day 15 are presented.
Cpre,ss,15 represents the pre-dose concentration of afatinib in plasma at steady state on day 15.
Outcome measures
| Measure |
Afatinib 50mg
n=28 Participants
Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
|
Afatinib 50mg 2nd Line
n=17 Participants
Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors). Only Patients with 2nd line anti cancer treatment, indicating that they had received one prior anti cancer treatment with chemotherapy.
|
|---|---|---|
|
Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 15 (Cpre,ss,15)
|
37.9 ng/mL
Geometric Coefficient of Variation 64.5
|
29.7 ng/mL
Geometric Coefficient of Variation 61.6
|
SECONDARY outcome
Timeframe: First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeksPopulation: Treated Set (TS).
The safety of patients was overall assessed in terms of adverse events (AEs), graded according to US NCI CTCAE version 3.0 \[R04-0474\], including skin reactions and gastrointestinal AEs.
Outcome measures
| Measure |
Afatinib 50mg
n=69 Participants
Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
|
Afatinib 50mg 2nd Line
Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors). Only Patients with 2nd line anti cancer treatment, indicating that they had received one prior anti cancer treatment with chemotherapy.
|
|---|---|---|
|
Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder
Diarrhoea
|
82.6 Percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder
Stomatitis
|
13.0 Percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder
Nausea
|
14.5 Percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder
Vomiting
|
13.0 Percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder
Constipation
|
7.2 Percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder
Abdominal pain
|
5.8 Percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder
Abdominal pain upper
|
2.9 Percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder
Cheilitis
|
2.9 Percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder
Dyspepsia
|
2.9 Percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder
Dysphagia
|
2.9 Percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder
Abdominal distension
|
1.4 Percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder
Dry mouth
|
1.4 Percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder
Flatulence
|
1.4 Percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder
Gastritis erosive
|
1.4 Percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder
Odynophagia
|
1.4 Percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder
Peritoneal haemorrhage
|
1.4 Percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder
Rectal haemorrahage
|
1.4 Percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder
Tongue Ulceration
|
1.4 Percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder
Rash
|
73.9 Percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder
Skin exfoliation
|
15.9 Percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder
Dry skin
|
14.5 Percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder
Nail disorder
|
13.0 Percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder
Pruritus
|
13.0 Percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder
Dermatitis acneiform
|
5.8 Percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder
Alopecia
|
1.4 Percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder
Granuloma skin
|
1.4 Percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder
Hirsutism
|
1.4 Percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder
Hypertrichosis
|
1.4 Percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder
Nail discolouration
|
1.4 Percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder
Night sweats
|
1.4 Percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder
palmar-plantar erythrodysaesthesia syndrome
|
1.4 Percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder
Skin fissures
|
1.4 Percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder
Skin reaction
|
1.4 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeksPopulation: Treated Set (TS).
Number of participants with clinical relevant findings in Laboratory safety parameters, vital signs and Left ventricular ejection fraction . Relevant findings or worsenings of baseline conditions were reported as Adverse Events. There were no clinically relevant finding reported for Vital signs and Left ventricular ejection fraction (LVEF).
Outcome measures
| Measure |
Afatinib 50mg
n=69 Participants
Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
|
Afatinib 50mg 2nd Line
Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors). Only Patients with 2nd line anti cancer treatment, indicating that they had received one prior anti cancer treatment with chemotherapy.
|
|---|---|---|
|
Number of Participants With Clinical Relevant Findings in Laboratory Safety Parameters, Vital Signs and Left Ventricular Ejection Fraction
Alanine aminotransferase increased
|
2.9 percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Findings in Laboratory Safety Parameters, Vital Signs and Left Ventricular Ejection Fraction
Aspartate aminotransferase increased
|
2.9 percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Findings in Laboratory Safety Parameters, Vital Signs and Left Ventricular Ejection Fraction
Blood alkaline phosphatase increased
|
2.9 percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Findings in Laboratory Safety Parameters, Vital Signs and Left Ventricular Ejection Fraction
Blood bilirubin increased
|
1.4 percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Findings in Laboratory Safety Parameters, Vital Signs and Left Ventricular Ejection Fraction
Blood Creatine phosphokinase increased
|
1.4 percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Findings in Laboratory Safety Parameters, Vital Signs and Left Ventricular Ejection Fraction
Blood lactate dehydrogenase increased
|
1.4 percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Findings in Laboratory Safety Parameters, Vital Signs and Left Ventricular Ejection Fraction
Ejection fraction decreased
|
1.4 percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Findings in Laboratory Safety Parameters, Vital Signs and Left Ventricular Ejection Fraction
Gamma-glutamyltransferase increased
|
1.4 percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Findings in Laboratory Safety Parameters, Vital Signs and Left Ventricular Ejection Fraction
International normalised ratio increased
|
1.4 percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Findings in Laboratory Safety Parameters, Vital Signs and Left Ventricular Ejection Fraction
Transaminases increased
|
2.9 percentage of participants
|
—
|
|
Number of Participants With Clinical Relevant Findings in Laboratory Safety Parameters, Vital Signs and Left Ventricular Ejection Fraction
Weight decreased
|
7.2 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: End Of Treatment, up until 190 weeksPopulation: Treated set (TS).
Performance status assessed according to Eastern Cooperative Oncology Group (ECOG) performance status based on categories defined below : 0 : Fully active, able to carry on all pre-disease performance without restriction. 1. : Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. : Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. : Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours. 4. : Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair. 5. : Dead. Note: The ECOG scores presented are assessed at the end of treatment not at baseline, hence the patients having ECOGs\>2 are included.
Outcome measures
| Measure |
Afatinib 50mg
n=69 Participants
Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
|
Afatinib 50mg 2nd Line
Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors). Only Patients with 2nd line anti cancer treatment, indicating that they had received one prior anti cancer treatment with chemotherapy.
|
|---|---|---|
|
Assessment of Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
23.2 percentage of participants
|
—
|
|
Assessment of Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
40.6 percentage of participants
|
—
|
|
Assessment of Eastern Cooperative Oncology Group (ECOG) Performance Status
2
|
7.2 percentage of participants
|
—
|
|
Assessment of Eastern Cooperative Oncology Group (ECOG) Performance Status
3
|
1.4 percentage of participants
|
—
|
|
Assessment of Eastern Cooperative Oncology Group (ECOG) Performance Status
4
|
1.4 percentage of participants
|
—
|
|
Assessment of Eastern Cooperative Oncology Group (ECOG) Performance Status
Missing
|
26.1 percentage of participants
|
—
|
Adverse Events
Afatinib 50mg
Serious events: 35 serious events
Other events: 66 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Afatinib 50mg
n=69 participants at risk
Afatinib 50mg film coated tablets where administered once daily as long as they were tolerated by patients, until a disease progression (according to the response evaluation criteria in solid tumors)
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
1/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.4%
1/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Cardiac disorders
Cardiac failure congestive
|
1.4%
1/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Gastrointestinal disorders
Constipation
|
1.4%
1/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
5.8%
4/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Gastrointestinal disorders
Gastritis erosive
|
1.4%
1/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
1.4%
1/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
1/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
General disorders
Chest pain
|
1.4%
1/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
General disorders
Death
|
2.9%
2/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
General disorders
Fatigue
|
1.4%
1/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
General disorders
General physical health deterioration
|
1.4%
1/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
General disorders
Pyrexia
|
1.4%
1/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Infections and infestations
Gastroenteritis
|
1.4%
1/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Infections and infestations
Pneumonia
|
1.4%
1/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Infections and infestations
Sepsis
|
1.4%
1/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Infections and infestations
Subcutaneous abscess
|
1.4%
1/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Infections and infestations
Urinary tract infection
|
1.4%
1/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.4%
1/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
2/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.4%
1/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
1.4%
1/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.4%
1/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.4%
1/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.4%
1/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
7.2%
5/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
2.9%
2/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Nervous system disorders
Syncope
|
1.4%
1/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Psychiatric disorders
Confusional state
|
1.4%
1/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Psychiatric disorders
Mental disorder
|
1.4%
1/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Renal and urinary disorders
Renal colic
|
1.4%
1/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Renal and urinary disorders
Renal failure acute
|
2.9%
2/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.3%
3/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.3%
3/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.4%
1/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.4%
1/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.3%
3/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Vascular disorders
Superior vena cava syndrome
|
2.9%
2/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Vascular disorders
Vena cava thrombosis
|
1.4%
1/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
Other adverse events
| Measure |
Afatinib 50mg
n=69 participants at risk
Afatinib 50mg film coated tablets where administered once daily as long as they were tolerated by patients, until a disease progression (according to the response evaluation criteria in solid tumors)
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.8%
4/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Eye disorders
Conjunctivitis
|
11.6%
8/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
5.8%
4/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Gastrointestinal disorders
Constipation
|
5.8%
4/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
76.8%
53/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Gastrointestinal disorders
Nausea
|
14.5%
10/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Gastrointestinal disorders
Stomatitis
|
13.0%
9/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Gastrointestinal disorders
Vomiting
|
11.6%
8/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
General disorders
Asthenia
|
5.8%
4/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
General disorders
Fatigue
|
27.5%
19/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
General disorders
Mucosal inflammation
|
29.0%
20/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
General disorders
Pyrexia
|
18.8%
13/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Infections and infestations
Cystitis
|
7.2%
5/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Investigations
Weight decreased
|
7.2%
5/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
24.6%
17/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.9%
11/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.8%
4/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.4%
12/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
5.8%
4/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.5%
10/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
13.0%
9/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.0%
9/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
73.9%
51/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
15.9%
11/69 • First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
|
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