Trial Outcomes & Findings for All-Case Surveillance of Ofev in Patients With IPF in Japan (NCT NCT02607722)
NCT ID: NCT02607722
Last Updated: 2024-10-15
Results Overview
Number of patients with any suspected Adverse Drug Reactions (ADRs) is presented.
Recruitment status
COMPLETED
Target enrollment
10117 participants
Primary outcome timeframe
Up to 104 weeks
Results posted on
2024-10-15
Participant Flow
This non-interventional study based on newly collected data aimed to evaluate safety and effectiveness of Ofev Capsules treatment in patients with Idiopathic Pulmonary Fibrosis (IPF) who newly initiated Ofev capsules under a real-world setting.
Only subjects that met all inclusion and none of the exclusion criteria were included. Patients diagnosed with idiopathic pulmonary fibrosis (IPF) based upon the most recent ATS/ERS/JRS/ALAT guideline and who initiated treatment with Ofev Capsules after the launch were registered into this study basically within 14 days from initiation of Ofev Capsules (from October 2015 to May 2023, following enrollment in August 31st).
Participant milestones
| Measure |
IPF Patients Receiving Nintedanib
Patients diagnosed with idiopathic pulmonary fibrosis (IPF) based upon the most recent ATS/ERS/JRS/ALAT guideline and who initiated treatment with Ofev Capsules after the launch were registered into this study basically within 14 days from initiation of Ofev Capsules (from October 2015 to May 2023, following enrollment in August 31st).
|
|---|---|
|
Overall Study
STARTED
|
10117
|
|
Overall Study
Treated
|
5753
|
|
Overall Study
COMPLETED
|
1535
|
|
Overall Study
NOT COMPLETED
|
8582
|
Reasons for withdrawal
| Measure |
IPF Patients Receiving Nintedanib
Patients diagnosed with idiopathic pulmonary fibrosis (IPF) based upon the most recent ATS/ERS/JRS/ALAT guideline and who initiated treatment with Ofev Capsules after the launch were registered into this study basically within 14 days from initiation of Ofev Capsules (from October 2015 to May 2023, following enrollment in August 31st).
|
|---|---|
|
Overall Study
No data reliability
|
1
|
|
Overall Study
no patient visit
|
18
|
|
Overall Study
missing info in CRF
|
13
|
|
Overall Study
Withdrawal by Subject
|
616
|
|
Overall Study
Lost to Follow-up
|
312
|
|
Overall Study
Improved
|
22
|
|
Overall Study
Lack of Efficacy
|
316
|
|
Overall Study
Adverse Event
|
2553
|
|
Overall Study
Not treated
|
1
|
|
Overall Study
No CRF collected
|
138
|
|
Overall Study
without CRF
|
4225
|
|
Overall Study
Physician Decision
|
367
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
IPF Patients Receiving Nintedanib
n=5734 Participants
Patients diagnosed with idiopathic pulmonary fibrosis (IPF) based upon the most recent ATS/ERS/JRS/ALAT guideline and who initiated treatment with Ofev Capsules after the launch were registered into this study basically within 14 days from initiation of Ofev Capsules (from October 2015 to May 2023, following enrollment in August 31st).
|
|---|---|
|
Age, Continuous
|
71.7 Years
STANDARD_DEVIATION 8.1 • n=5734 Participants
|
|
Sex: Female, Male
Female
|
1256 Participants
n=5734 Participants
|
|
Sex: Female, Male
Male
|
4478 Participants
n=5734 Participants
|
PRIMARY outcome
Timeframe: Up to 104 weeksPopulation: Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
Number of patients with any suspected Adverse Drug Reactions (ADRs) is presented.
Outcome measures
| Measure |
IPF Patients Receiving Nintedanib
n=5734 Participants
Patients diagnosed with idiopathic pulmonary fibrosis (IPF) based upon the most recent ATS/ERS/JRS/ALAT guideline and who initiated treatment with Ofev Capsules after the launch were registered into this study basically within 14 days from initiation of Ofev Capsules (from October 2015 to May 2023, following enrollment in August 31st).
|
|---|---|
|
Number of Patients With Any Suspected Adverse Drug Reactions (ADRs)
|
3852 Participants
|
SECONDARY outcome
Timeframe: At baseline and at week 104Population: Effectiveness set: This patient set included all patients with Ofev Capsules in the safety set who were suffering from the approved indication. Further important protocol deviations (IPDs) leading to exclusion from this analysis set were predefined. Only patients with FVC and %FVC value at baseline and post treatment in effectiveness set were included in this analysis.
Absolute change from baseline in Forced Vital Capacity (FVC) at Week 104 is presented. Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It is measured in Milliliter by spirometry.
Outcome measures
| Measure |
IPF Patients Receiving Nintedanib
n=481 Participants
Patients diagnosed with idiopathic pulmonary fibrosis (IPF) based upon the most recent ATS/ERS/JRS/ALAT guideline and who initiated treatment with Ofev Capsules after the launch were registered into this study basically within 14 days from initiation of Ofev Capsules (from October 2015 to May 2023, following enrollment in August 31st).
|
|---|---|
|
Absolute Change From Baseline in Forced Vital Capacity (FVC) at Week 104
|
-152.5 MilliLiter (mL)
Standard Deviation 323.0
|
Adverse Events
IPF Patients Receiving Nintedanib
Serious events: 2326 serious events
Other events: 3239 other events
Deaths: 1137 deaths
Serious adverse events
| Measure |
IPF Patients Receiving Nintedanib
n=5734 participants at risk
Patients diagnosed with idiopathic pulmonary fibrosis (IPF) based upon the most recent ATS/ERS/JRS/ALAT guideline and who initiated treatment with Ofev Capsules after the launch were registered into this study basically within 14 days from initiation of Ofev Capsules (from October 2015 to May 2023, following enrollment in August 31st).
|
|---|---|
|
Blood and lymphatic system disorders
Acquired haemophilia
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.09%
5/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.12%
7/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.12%
7/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.07%
4/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.10%
6/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Cardiac disorders
Angina pectoris
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Cardiac disorders
Angina unstable
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Cardiac disorders
Atrial fibrillation
|
0.12%
7/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Cardiac disorders
Atrial flutter
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Cardiac disorders
Atrial thrombosis
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Cardiac disorders
Atrioventricular block
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Cardiac disorders
Bundle branch block right
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Cardiac disorders
Cardiac arrest
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Cardiac disorders
Cardiac dysfunction
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Cardiac disorders
Cardiac failure
|
0.99%
57/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Cardiac disorders
Cardiac failure acute
|
0.07%
4/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.26%
15/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.31%
18/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Cardiac disorders
Cardiogenic shock
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Cardiac disorders
Cardiomegaly
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Cardiac disorders
Cor pulmonale
|
0.09%
5/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Cardiac disorders
Myocardial infarction
|
0.09%
5/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Cardiac disorders
Pericarditis
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Cardiac disorders
Prinzmetal angina
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Cardiac disorders
Right ventricular failure
|
0.21%
12/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Ear and labyrinth disorders
Deafness
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Endocrine disorders
Hypothyroidism
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.09%
5/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Eye disorders
Cataract
|
0.07%
4/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Eye disorders
Epiretinal membrane
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Eye disorders
Glaucoma
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Eye disorders
Macular hole
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Eye disorders
Retinal detachment
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Eye disorders
Tolosa-Hunt syndrome
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Anal fistula
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Ascites
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.07%
4/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Constipation
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.91%
52/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.07%
4/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Dysphagia
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.10%
6/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Food poisoning
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.17%
10/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Gastrointestinal mucosal exfoliation
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.07%
4/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Haematochezia
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Ileus
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Lower gastrointestinal perforation
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.10%
6/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Melaena
|
0.10%
6/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Mesenteric panniculitis
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Nausea
|
0.16%
9/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.09%
5/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Rectal ulcer
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Volvulus
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Vomiting
|
0.12%
7/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
General disorders
Asthenia
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
General disorders
Chest pain
|
0.09%
5/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
General disorders
Chills
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
General disorders
Condition aggravated
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
General disorders
Death
|
0.89%
51/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
General disorders
Decreased activity
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
General disorders
Disease progression
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
General disorders
General physical health deterioration
|
0.19%
11/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
General disorders
Inflammation
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
General disorders
Malaise
|
0.16%
9/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.07%
4/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
General disorders
Oedema
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
General disorders
Oedema peripheral
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
General disorders
Pain
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
General disorders
Pyrexia
|
0.31%
18/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
General disorders
Sudden cardiac death
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
General disorders
Sudden death
|
0.10%
6/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.07%
4/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Hepatobiliary disorders
Biliary colic
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Hepatobiliary disorders
Cholangitis
|
0.07%
4/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.23%
13/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.09%
5/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.40%
23/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.0%
58/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Hepatobiliary disorders
Jaundice
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Hepatobiliary disorders
Liver disorder
|
0.66%
38/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Hepatobiliary disorders
Liver injury
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Immune system disorders
Amyloidosis
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Immune system disorders
Anti-neutrophil cytoplasmic antibody positive vasculitis
|
0.16%
9/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Immune system disorders
Decreased immune responsiveness
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Abscess
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Appendicitis
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Appendicitis perforated
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Aspergilloma
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Aspergillus infection
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Atypical mycobacterial infection
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Bacterial infection
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Brain abscess
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Bronchitis
|
0.31%
18/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Bronchitis bacterial
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.31%
18/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Cellulitis
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Cholangitis infective
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Complicated appendicitis
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Cryptococcosis
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Diabetic gangrene
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Diverticulitis
|
0.09%
5/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Enteritis infectious
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Enterococcal infection
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Enterocolitis bacterial
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Fungal infection
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Gastroenteritis
|
0.09%
5/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Hepatitis B reactivation
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Herpes zoster
|
0.14%
8/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Herpes zoster disseminated
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Infection
|
0.12%
7/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Infectious pleural effusion
|
0.12%
7/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Influenza
|
0.38%
22/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Liver abscess
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.10%
6/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Meningitis cryptococcal
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Mycobacterial infection
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Mycobacterium avium complex infection
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Nasopharyngitis
|
0.09%
5/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Oral fungal infection
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Peritonitis
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Pharyngitis
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Pneumococcal infection
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.07%
4/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Pneumonia
|
3.6%
207/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Pneumonia aspiration
|
1.0%
58/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Pneumonia bacterial
|
2.7%
155/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Pneumonia fungal
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Pneumonia influenzal
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Pneumonia legionella
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Pneumonia moraxella
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.14%
8/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Pneumonia viral
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.07%
4/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Pyelonephritis
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Pyelonephritis acute
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Pyuria
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Respiratory tract infection
|
0.44%
25/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Scedosporium infection
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Sepsis
|
0.21%
12/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Septic shock
|
0.07%
4/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Sinusitis
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Subcutaneous abscess
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Systemic candida
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Urinary tract infection
|
0.19%
11/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Infections and infestations
Viral infection
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Injury, poisoning and procedural complications
Fall
|
0.10%
6/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Injury, poisoning and procedural complications
Heat illness
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Injury, poisoning and procedural complications
Injury
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Injury, poisoning and procedural complications
Open fracture
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Injury, poisoning and procedural complications
Pancreatic leak
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Injury, poisoning and procedural complications
Pneumoconiosis
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.07%
4/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Injury, poisoning and procedural complications
Wound
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Investigations
Alanine aminotransferase increased
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Investigations
Aspartate aminotransferase increased
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Investigations
Blood bilirubin increased
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Investigations
Blood creatinine increased
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Investigations
Blood glucose increased
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Investigations
Blood pressure decreased
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Investigations
Blood pressure increased
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Investigations
Brain natriuretic peptide increased
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Investigations
C-reactive protein increased
|
0.16%
9/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Investigations
Fibrin D dimer increased
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Investigations
Hepatic enzyme abnormal
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Investigations
Hepatic enzyme increased
|
0.10%
6/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Investigations
KL-6 increased
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Investigations
Liver function test abnormal
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Investigations
Liver function test increased
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Investigations
Neutrophil count decreased
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Investigations
Oxygen saturation decreased
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Investigations
Platelet count decreased
|
0.23%
13/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Investigations
Red blood cell morphology abnormal
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Investigations
Weight decreased
|
0.09%
5/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Investigations
White blood cell count decreased
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.2%
67/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.19%
11/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.10%
6/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.16%
9/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Metabolism and nutrition disorders
Marasmus
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Metabolism and nutrition disorders
Zinc deficiency
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Musculoskeletal and connective tissue disorders
Haematoma muscle
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Musculoskeletal and connective tissue disorders
Immobilisation syndrome
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Musculoskeletal and connective tissue disorders
Periostitis
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Musculoskeletal and connective tissue disorders
Polymyositis
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Musculoskeletal and connective tissue disorders
Sarcopenia
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Musculoskeletal and connective tissue disorders
Scleroderma
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.07%
4/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer metastatic
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.09%
5/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.16%
9/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.26%
15/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer recurrent
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.12%
7/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma recurrent
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified recurrent
|
0.21%
12/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.96%
55/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis carcinomatosa
|
0.09%
5/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of unknown primary site
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
1.4%
82/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.07%
4/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to adrenals
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.10%
6/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.10%
6/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasal cavity cancer
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.07%
4/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.10%
6/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.12%
7/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.12%
7/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Nervous system disorders
Altered state of consciousness
|
0.09%
5/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Nervous system disorders
Cerebellar infarction
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Nervous system disorders
Cerebral infarction
|
0.38%
22/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Nervous system disorders
Dementia
|
0.12%
7/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Nervous system disorders
Dizziness
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Nervous system disorders
Embolic stroke
|
0.10%
6/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Nervous system disorders
Encephalopathy
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Nervous system disorders
Epilepsy
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Nervous system disorders
Facial paralysis
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Nervous system disorders
Hemiplegia
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Nervous system disorders
Hypoaesthesia
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Nervous system disorders
Lacunar infarction
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Nervous system disorders
Loss of consciousness
|
0.07%
4/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Nervous system disorders
Myelopathy
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Nervous system disorders
Paralysis
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Nervous system disorders
Paralysis recurrent laryngeal nerve
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Nervous system disorders
Parkinson's disease
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Nervous system disorders
Sciatica
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Nervous system disorders
Stupor
|
0.09%
5/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Nervous system disorders
Thalamus haemorrhage
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Psychiatric disorders
Delirium
|
0.17%
10/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Psychiatric disorders
Depression
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Psychiatric disorders
Eating disorder
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Psychiatric disorders
Mania
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Renal and urinary disorders
Azotaemia
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Renal and urinary disorders
Bladder perforation
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Renal and urinary disorders
Glomerulonephritis rapidly progressive
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Renal and urinary disorders
Haematuria
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Renal and urinary disorders
IgA nephropathy
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.09%
5/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Renal and urinary disorders
Pollakiuria
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Renal and urinary disorders
Proteinuria
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Renal and urinary disorders
Renal disorder
|
0.10%
6/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Renal and urinary disorders
Renal failure
|
0.07%
4/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Renal and urinary disorders
Renal impairment
|
0.12%
7/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Renal and urinary disorders
Renal infarct
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.09%
5/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.23%
13/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial haemorrhage
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.10%
6/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.40%
23/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Cystic lung disease
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.3%
73/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.14%
8/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.16%
9/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.14%
8/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Hypersensitivity pneumonitis
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.21%
12/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic interstitial pneumonia
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
17.4%
1000/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.78%
45/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Lung cyst
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.16%
9/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.72%
41/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.3%
191/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.26%
15/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.10%
6/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.23%
13/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fistula
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.87%
50/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.8%
102/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.07%
4/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Surgical and medical procedures
Lung transplant
|
0.07%
4/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Surgical and medical procedures
Prostatic operation
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Surgical and medical procedures
Pulmonary resection
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Surgical and medical procedures
Surgery
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Vascular disorders
Aortic aneurysm
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Vascular disorders
Aortic dissection
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Vascular disorders
Artery dissection
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Vascular disorders
Circulatory collapse
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Vascular disorders
Deep vein thrombosis
|
0.12%
7/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Vascular disorders
Embolism arterial
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Vascular disorders
Hypertension
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Vascular disorders
Microscopic polyangiitis
|
0.03%
2/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Vascular disorders
Paradoxical embolism
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Vascular disorders
Peripheral circulatory failure
|
0.02%
1/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Vascular disorders
Venous thrombosis limb
|
0.05%
3/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
Other adverse events
| Measure |
IPF Patients Receiving Nintedanib
n=5734 participants at risk
Patients diagnosed with idiopathic pulmonary fibrosis (IPF) based upon the most recent ATS/ERS/JRS/ALAT guideline and who initiated treatment with Ofev Capsules after the launch were registered into this study basically within 14 days from initiation of Ofev Capsules (from October 2015 to May 2023, following enrollment in August 31st).
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
35.5%
2036/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Gastrointestinal disorders
Nausea
|
6.1%
347/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
14.5%
829/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Hepatobiliary disorders
Liver disorder
|
7.6%
437/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.1%
579/5734 • Up to week 104
Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER