Trial Outcomes & Findings for Long-term Observation PMS for Afatinib (NCT NCT02131259)
NCT ID: NCT02131259
Last Updated: 2018-09-07
Results Overview
This outcome measure presents incidence of adverse drug reactions (ADRs). An ADR was defined as an AE if either the investigator or the sponsor (or both) assessed the causal relationship to GIOTRIF® Tablets either as "Yes", "Probably yes" or "Can't be denied". The number of patients with Adverse Drug Reactions (ADRs): "Malignant progression" reported as ADRs were included.
Recruitment status
COMPLETED
Target enrollment
1605 participants
Primary outcome timeframe
From first drug administration until 28 days after the last drug administration, up to 52 weeks.
Results posted on
2018-09-07
Participant Flow
Case Report Form (CRF) collected for 1605 patients, 1602 added in safety set. 1 patient excluded due to out of contract period, 1 due to no treatment (with GIOTRIF) and 1 patient received (GIOTRIF) treatment before registration (total 3 patients excluded from the safety set). Participant flow is based on safety set.
This was a non-interventional, prospective, observational, single arm study based on new data collection.
Participant milestones
| Measure |
Afatinib Dimaleate
The patients were administered single daily dose of Afatinib dimaleate tablet (GIOTRIF® Tablets), starting at 40 milligram (mg) orally up to a period of 52 weeks. The dosage might be adjusted according to the patient's tolerability, with a maximum daily dose of 50 mg.
|
|---|---|
|
Overall Study
STARTED
|
1602
|
|
Overall Study
COMPLETED
|
377
|
|
Overall Study
NOT COMPLETED
|
1225
|
Reasons for withdrawal
| Measure |
Afatinib Dimaleate
The patients were administered single daily dose of Afatinib dimaleate tablet (GIOTRIF® Tablets), starting at 40 milligram (mg) orally up to a period of 52 weeks. The dosage might be adjusted according to the patient's tolerability, with a maximum daily dose of 50 mg.
|
|---|---|
|
Overall Study
Progressive disease
|
751
|
|
Overall Study
Adverse Event
|
341
|
|
Overall Study
Lost to Follow-up
|
7
|
|
Overall Study
Relocation
|
32
|
|
Overall Study
Other
|
63
|
|
Overall Study
Progressive disease/Adverse Event (AE)
|
22
|
|
Overall Study
Progressive disease/relocation
|
1
|
|
Overall Study
Progressive disease/other
|
2
|
|
Overall Study
AE/lost to follow-up
|
1
|
|
Overall Study
AE/other
|
1
|
|
Overall Study
Progressive disease/AE/other
|
1
|
|
Overall Study
Missing
|
3
|
Baseline Characteristics
Long-term Observation PMS for Afatinib
Baseline characteristics by cohort
| Measure |
Afatinib Dimaleate
n=1602 Participants
The patients were administered single daily dose of Afatinib dimaleate tablet (GIOTRIF® Tablets), starting at 40 milligram (mg) orally up to a period of 52 weeks. The dosage might be adjusted according to the patient's tolerability, with a maximum daily dose of 50 mg.
|
|---|---|
|
Age, Continuous
|
65.9 Years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
947 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
655 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first drug administration until 28 days after the last drug administration, up to 52 weeks.Population: Safety Set: This analysis set included all patients who had received treatment of GIOTRIF® tablets except those who were found not following registration rules, invalid contract or previous treatment experience with GIOTRIF® tablets.
This outcome measure presents incidence of adverse drug reactions (ADRs). An ADR was defined as an AE if either the investigator or the sponsor (or both) assessed the causal relationship to GIOTRIF® Tablets either as "Yes", "Probably yes" or "Can't be denied". The number of patients with Adverse Drug Reactions (ADRs): "Malignant progression" reported as ADRs were included.
Outcome measures
| Measure |
Afatinib Dimaleate
n=1602 Participants
The patients were administered single daily dose of Afatinib dimaleate tablet (GIOTRIF® Tablets), starting at 40 milligram (mg) orally up to a period of 52 weeks. The dosage might be adjusted according to the patient's tolerability, with a maximum daily dose of 50 mg.
|
|---|---|
|
Incidence of Adverse Drug Reactions (ADRs)
|
95.19 Percentage of Participants
|
SECONDARY outcome
Timeframe: 52 weeks.Population: Efficacy Set: This analysis set was a subset of the safety set, which included all patients in the safety set except those who had no available tumour assessment and/or who did not suffer from Epidermal Growth Factor Receptor (EGFR) mutation-positive inoperable or recurrent Non-Small Cell Lung Cancer (NSCLC).
Objective overall response based on investigator's assessment (according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for target lesions and assessed by MRI: complete response (CR) is the disappearance of all target lesions, a partial response (PR) is defined as at least a 30% decrease in the sum of the target lesion and stable disease (SD) is defined as fitting the criteria neither for progressive disease (PD) nor a PR. The population included the Tyrosine Kinase Inhibitor \[TKI\]-naïve patients and the TKI pre-treated patients. Overall response was calculated with 95% Clopper-Pearson confidence interval. OR = (CR+PR)/(CR+PR+SD+PD+Unknown)\*100.
Outcome measures
| Measure |
Afatinib Dimaleate
n=1602 Participants
The patients were administered single daily dose of Afatinib dimaleate tablet (GIOTRIF® Tablets), starting at 40 milligram (mg) orally up to a period of 52 weeks. The dosage might be adjusted according to the patient's tolerability, with a maximum daily dose of 50 mg.
|
|---|---|
|
Objective Overall Response Based on Physician's Assessment [According to RECIST Version 1.1]
|
40.07 Percentage of participants
Interval 37.66 to 42.52
|
Adverse Events
Afatinib Dimaleate
Serious events: 1129 serious events
Other events: 1432 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Afatinib Dimaleate
n=1602 participants at risk
The patients were administered single daily dose of Afatinib dimaleate tablet (GIOTRIF® Tablets), starting at 40 milligram (mg) orally up to a period of 52 weeks. The dosage might be adjusted according to the patient's tolerability, with a maximum daily dose of 50 mg.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Vascular disorders
Aortic dissection
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Vascular disorders
Hypertension
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Vascular disorders
Hypotension
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Vascular disorders
Peripheral coldness
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Vascular disorders
Deep vein thrombosis
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Vascular disorders
Trousseau's syndrome
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Vascular disorders
Embolism
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.56%
9/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.12%
2/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Cardiac disorders
Cardiac failure
|
0.19%
3/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Cardiac disorders
Pericardial effusion
|
0.12%
2/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Cardiac disorders
Arrhythmia
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Cardiac disorders
Cardiac arrest
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Cardiac disorders
Cardiac tamponade
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Cardiac disorders
Cardiomyopathy
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Endocrine disorders
Adrenal mass
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Eye disorders
Retinal detachment
|
0.12%
2/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Eye disorders
Diplopia
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Eye disorders
Iridocyclitis
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Eye disorders
Vision blurred
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Eye disorders
Visual impairment
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Eye disorders
Ulcerative keratitis
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.3%
117/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Gastrointestinal disorders
Stomatitis
|
1.6%
26/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
18/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Gastrointestinal disorders
Nausea
|
0.87%
14/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.31%
5/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Gastrointestinal disorders
Ileus
|
0.31%
5/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.19%
3/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Gastrointestinal disorders
Melaena
|
0.19%
3/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.12%
2/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.12%
2/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Gastrointestinal disorders
Dysphagia
|
0.12%
2/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.12%
2/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Gastrointestinal disorders
Glossitis
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Gastrointestinal disorders
Haematemesis
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Gastrointestinal disorders
Subileus
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Gastrointestinal disorders
Gastric mucosal lesion
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Gastrointestinal disorders
Small intestinal ulcer haemorrhage
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Gastrointestinal disorders
Oral disorder
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
General disorders
Malaise
|
0.75%
12/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
General disorders
Pyrexia
|
0.56%
9/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
General disorders
General physical health deterioration
|
0.19%
3/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
General disorders
Oedema peripheral
|
0.12%
2/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
General disorders
Pain
|
0.12%
2/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
General disorders
Asthenia
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
General disorders
Feeling abnormal
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
General disorders
Gait disturbance
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
General disorders
Performance status decreased
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
General disorders
Inflammation
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
General disorders
Disuse syndrome
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Hepatobiliary disorders
Liver disorder
|
0.25%
4/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.19%
3/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.19%
3/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.12%
2/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Hepatobiliary disorders
Cholangitis
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Immune system disorders
Anaphylactic reaction
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Infections and infestations
Paronychia
|
0.50%
8/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Infections and infestations
Pneumonia
|
0.37%
6/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Infections and infestations
Meningitis
|
0.25%
4/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Infections and infestations
Pneumonia bacterial
|
0.25%
4/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Infections and infestations
Gastroenteritis
|
0.19%
3/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Infections and infestations
Lung infection
|
0.12%
2/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Infections and infestations
Cellulitis
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Infections and infestations
Encephalitis
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Infections and infestations
Gastroenteritis staphylococcal
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Infections and infestations
Herpes zoster
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Infections and infestations
Infection
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Infections and infestations
Influenza
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Infections and infestations
Peritonitis
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Infections and infestations
Pyelonephritis
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Infections and infestations
Skin infection
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Infections and infestations
Urinary tract infection
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Infections and infestations
Urosepsis
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Infections and infestations
Pneumonia cryptococcal
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Infections and infestations
Device related sepsis
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.19%
3/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.19%
3/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Injury, poisoning and procedural complications
Fall
|
0.12%
2/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Investigations
Blood creatinine increased
|
0.37%
6/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Investigations
Amylase increased
|
0.19%
3/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Investigations
Blood urea increased
|
0.12%
2/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Investigations
Carcinoembryonic antigen increased
|
0.12%
2/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Investigations
Neutrophil count decreased
|
0.12%
2/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Investigations
Alanine aminotransferase increased
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Investigations
Aspartate aminotransferase increased
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Investigations
Blood pressure decreased
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Investigations
Lipase increased
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Investigations
Oxygen saturation decreased
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Investigations
Platelet count decreased
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Investigations
Transaminases increased
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.1%
50/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.2%
35/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Metabolism and nutrition disorders
Feeding disorder
|
0.19%
3/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.12%
2/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.12%
2/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.12%
2/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Metabolism and nutrition disorders
Gout
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Metabolism and nutrition disorders
Hyperphosphatasaemia
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.12%
2/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.12%
2/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
50.7%
813/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
1.7%
27/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
1.2%
20/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.87%
14/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.62%
10/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.50%
8/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis carcinomatosa
|
0.50%
8/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.44%
7/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.31%
5/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.25%
4/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.19%
3/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to adrenals
|
0.19%
3/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.19%
3/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.12%
2/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer recurrent
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of pleura
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to skin
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant peritoneal neoplasm
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung infiltration malignant
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Nervous system disorders
Cerebral infarction
|
0.31%
5/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.31%
5/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Nervous system disorders
Dizziness
|
0.19%
3/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Nervous system disorders
Altered state of consciousness
|
0.12%
2/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.12%
2/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Nervous system disorders
Headache
|
0.12%
2/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Nervous system disorders
Seizure
|
0.12%
2/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Nervous system disorders
Dementia
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Nervous system disorders
Epilepsy
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Nervous system disorders
Hypoaesthesia
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Nervous system disorders
IIIrd nerve paralysis
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Nervous system disorders
Leukoencephalopathy
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Nervous system disorders
Memory impairment
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Nervous system disorders
Monoparesis
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Nervous system disorders
Monoplegia
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Nervous system disorders
Paralysis
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Nervous system disorders
Temporal lobe epilepsy
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Psychiatric disorders
Delirium
|
0.25%
4/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Psychiatric disorders
Depression
|
0.19%
3/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Psychiatric disorders
Eating disorder
|
0.12%
2/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Psychiatric disorders
Confusional state
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Psychiatric disorders
Adjustment disorder
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Renal and urinary disorders
Renal impairment
|
0.37%
6/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.37%
6/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Renal and urinary disorders
Renal disorder
|
0.19%
3/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Renal and urinary disorders
Prerenal failure
|
0.19%
3/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Renal and urinary disorders
Renal failure
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Renal and urinary disorders
Renal infarct
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Renal and urinary disorders
Ureteric rupture
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
3.7%
60/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
18/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.00%
16/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.50%
8/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.44%
7/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.31%
5/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.25%
4/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.12%
2/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.12%
2/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.12%
2/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.12%
2/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Respiratory, thoracic and mediastinal disorders
Eosinophilic pneumonia
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.56%
9/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.19%
3/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.12%
2/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Skin and subcutaneous tissue disorders
Henoch-Schonlein purpura
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.06%
1/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
Other adverse events
| Measure |
Afatinib Dimaleate
n=1602 participants at risk
The patients were administered single daily dose of Afatinib dimaleate tablet (GIOTRIF® Tablets), starting at 40 milligram (mg) orally up to a period of 52 weeks. The dosage might be adjusted according to the patient's tolerability, with a maximum daily dose of 50 mg.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
73.2%
1173/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Gastrointestinal disorders
Stomatitis
|
29.5%
473/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Gastrointestinal disorders
Nausea
|
7.2%
116/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Infections and infestations
Paronychia
|
33.3%
533/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.2%
180/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Skin and subcutaneous tissue disorders
Rash
|
40.2%
644/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
11.4%
183/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Skin and subcutaneous tissue disorders
Acne
|
7.9%
126/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.2%
83/1602 • From first drug administration until 28 days after the last drug administration, up to 52 weeks.
The number of participants presented in "Serious Adverse Events" and "Other Adverse Events" includes subjects with progressive disease.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place