Trial Outcomes & Findings for A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis (NCT NCT03313180)
NCT ID: NCT03313180
Last Updated: 2024-02-20
Results Overview
Number of patients with any adverse event (AE) over the course of the trial.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
444 participants
Primary outcome timeframe
First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to approximate 60 months.
Results posted on
2024-02-20
Participant Flow
This was a prospective, open-label extension trial to assess long-term safety and tolerability of nintedanib in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) who had completed treatment (including the follow-up visit or end of treatment/study visit, respectively) of the randomised, double-blind, placebo-controlled parent trial 1199.214 or trial 1199-0340.
Only patients with SSc-ILD who completed one of the parent trials on treatment (i.e., did not discontinue treatment early) were eligible and were included in this trial if they fulfilled all the inclusion criteria and did not present any of the exclusion criteria.
Participant milestones
| Measure |
Nintedanib
Patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) who took part in the parent trials 1199.214 (Nintedanib or Placebo) or 1199-0340 (Nintedanib). Patients continued in this trial and received Nintedanib 150 mg (milligram) twice daily (bid) unless they had reduced their dose to 100 mg bid trial medication (Nintedanib or Placebo) in the parent trial.
Patients receiving 100 mg bid trial medication at the end of the parent trial could receive either Nintedanib 100 mg bid or 150 mg bid at the discretion of the investigator.
|
|---|---|
|
Overall Study
STARTED
|
444
|
|
Overall Study
COMPLETED
|
265
|
|
Overall Study
NOT COMPLETED
|
179
|
Reasons for withdrawal
| Measure |
Nintedanib
Patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) who took part in the parent trials 1199.214 (Nintedanib or Placebo) or 1199-0340 (Nintedanib). Patients continued in this trial and received Nintedanib 150 mg (milligram) twice daily (bid) unless they had reduced their dose to 100 mg bid trial medication (Nintedanib or Placebo) in the parent trial.
Patients receiving 100 mg bid trial medication at the end of the parent trial could receive either Nintedanib 100 mg bid or 150 mg bid at the discretion of the investigator.
|
|---|---|
|
Overall Study
Adverse Event
|
120
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Withdrawal by Subject
|
39
|
|
Overall Study
Other than listed above
|
15
|
|
Overall Study
Covid-19 related
|
2
|
Baseline Characteristics
A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis
Baseline characteristics by cohort
| Measure |
Nintedanib
n=444 Participants
Patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) who took part in the parent trials 1199.214 (Nintedanib or Placebo) or 1199-0340 (Nintedanib). Patients continued in this trial and received Nintedanib 150 mg (milligram) twice daily (bid) unless they had reduced their dose to 100 mg bid trial medication (Nintedanib or Placebo) in the parent trial.
Patients receiving 100 mg bid trial medication at the end of the parent trial could receive either Nintedanib 100 mg bid or 150 mg bid at the discretion of the investigator.
|
|---|---|
|
Age, Continuous
|
55.0 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
335 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
109 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
406 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
110 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
308 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to approximate 60 months.Population: Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication
Number of patients with any adverse event (AE) over the course of the trial.
Outcome measures
| Measure |
Nintedanib
n=444 Participants
Patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) who took part in the parent trials 1199.214 (Nintedanib or Placebo) or 1199-0340 (Nintedanib). Patients continued in this trial and received Nintedanib 150 mg (milligram) twice daily (bid) unless they had reduced their dose to 100 mg bid trial medication (Nintedanib or Placebo) in the parent trial.
Patients receiving 100 mg bid trial medication at the end of the parent trial could receive either Nintedanib 100 mg bid or 150 mg bid at the discretion of the investigator.
|
|---|---|
|
Number of Patients With Any Adverse Event (AE) Over the Course of the Trial
|
441 Participants
|
Adverse Events
Nintedanib
Serious events: 198 serious events
Other events: 425 other events
Deaths: 23 deaths
Serious adverse events
| Measure |
Nintedanib
n=444 participants at risk
Patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) who took part in the parent trials 1199.214 (Nintedanib or Placebo) or 1199-0340 (Nintedanib). Patients continued in this trial and received Nintedanib 150 mg (milligram) twice daily (bid) unless they had reduced their dose to 100 mg bid trial medication (Nintedanib or Placebo) in the parent trial.
Patients receiving 100 mg bid trial medication at the end of the parent trial could receive either Nintedanib 100 mg bid or 150 mg bid at the discretion of the investigator.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Cardiac disorders
Angina unstable
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Cardiac disorders
Arrhythmia
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Cardiac disorders
Atrial fibrillation
|
1.1%
5/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Cardiac disorders
Atrial flutter
|
0.45%
2/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Cardiac disorders
Atrial tachycardia
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Cardiac disorders
Cardiac arrest
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Cardiac disorders
Cardiac failure
|
1.6%
7/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.45%
2/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Cardiac disorders
Chordae tendinae rupture
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Cardiac disorders
Coronary artery disease
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Cardiac disorders
Left ventricular failure
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Cardiac disorders
Myocardial infarction
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Cardiac disorders
Palpitations
|
0.45%
2/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Cardiac disorders
Pericarditis
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Cardiac disorders
Right ventricular failure
|
0.68%
3/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Eye disorders
Blindness unilateral
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Eye disorders
Cataract
|
0.45%
2/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Eye disorders
Glaucoma
|
0.45%
2/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Eye disorders
Retinal detachment
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Eye disorders
Retinal tear
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Eye disorders
Vitreous detachment
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Colitis
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.90%
4/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Dysphagia
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Enteritis
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Ileus
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Intestinal pseudo-obstruction
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Melaena
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Vomiting
|
0.68%
3/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
General disorders
Asthenia
|
0.45%
2/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
General disorders
Chest discomfort
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
General disorders
Chest pain
|
0.45%
2/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
General disorders
Disease progression
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
General disorders
General physical health deterioration
|
0.45%
2/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
General disorders
Non-cardiac chest pain
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
General disorders
Pain
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
General disorders
Polyserositis
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
General disorders
Pyrexia
|
0.45%
2/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.45%
2/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.90%
4/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Hepatobiliary disorders
Hydrocholecystis
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Hepatobiliary disorders
Liver injury
|
1.1%
5/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Immune system disorders
Anti-neutrophil cytoplasmic antibody positive vasculitis
|
0.45%
2/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Arthritis bacterial
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Bronchiolitis
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Bronchitis
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Bronchitis viral
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
COVID-19
|
2.0%
9/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.68%
3/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Cellulitis
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Clostridium colitis
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Device related infection
|
0.45%
2/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Diarrhoea infectious
|
0.45%
2/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Enteritis infectious
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Escherichia infection
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Gallbladder abscess
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Gastroenteritis viral
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Haemophilus infection
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Infected bunion
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Infected skin ulcer
|
0.45%
2/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Infection
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Influenza
|
0.45%
2/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Intervertebral discitis
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Labyrinthitis
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Localised infection
|
0.45%
2/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.68%
3/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Osteomyelitis
|
0.90%
4/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Pneumonia
|
5.9%
26/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Pneumonia aspiration
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Pneumonia bacterial
|
0.68%
3/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Pneumonia viral
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Propionibacterium infection
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Respiratory tract infection
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Sepsis
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Septic shock
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Staphylococcal infection
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Subperiosteal abscess
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Tooth abscess
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Injury, poisoning and procedural complications
Dislocation of vertebra
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Injury, poisoning and procedural complications
Fall
|
0.45%
2/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Injury, poisoning and procedural complications
Spleen contusion
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.45%
2/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Investigations
Alanine aminotransferase increased
|
0.90%
4/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Investigations
Aspartate aminotransferase increased
|
0.68%
3/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Investigations
Ejection fraction decreased
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.45%
2/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Investigations
Hepatic enzyme increased
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Investigations
Human metapneumovirus test positive
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Investigations
Weight decreased
|
0.68%
3/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.45%
2/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Connective tissue disorder
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Crowned dens syndrome
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Scleroderma
|
0.90%
4/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Systemic scleroderma
|
0.45%
2/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoid cystic carcinoma
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiomyolipoma
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.90%
4/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.45%
2/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.68%
3/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.68%
3/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
1.1%
5/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to gallbladder
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.45%
2/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Splenic marginal zone lymphoma
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.45%
2/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell type acute leukaemia
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Nervous system disorders
Cerebral haematoma
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Nervous system disorders
Cerebral infarction
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Nervous system disorders
Epilepsy
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Nervous system disorders
Hypoaesthesia
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Nervous system disorders
Intracranial mass
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Nervous system disorders
Paraesthesia
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Nervous system disorders
Sciatica
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.90%
4/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Renal and urinary disorders
Glomerulonephritis rapidly progressive
|
0.45%
2/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Renal and urinary disorders
Renal failure
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.45%
2/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.68%
3/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
9/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
2.9%
13/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.45%
2/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.68%
3/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
2.0%
9/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.8%
8/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
1.6%
7/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
3.8%
17/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.1%
5/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Skin and subcutaneous tissue disorders
Ischaemic skin ulcer
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Skin and subcutaneous tissue disorders
Sclerema
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Skin and subcutaneous tissue disorders
Scleroderma associated digital ulcer
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Skin and subcutaneous tissue disorders
Skin hypertrophy
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
1.8%
8/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Vascular disorders
Arteriosclerosis
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Vascular disorders
Deep vein thrombosis
|
0.45%
2/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Vascular disorders
Dry gangrene
|
0.45%
2/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Vascular disorders
Extremity necrosis
|
0.45%
2/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Vascular disorders
Hypotension
|
0.45%
2/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Vascular disorders
Peripheral ischaemia
|
0.23%
1/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Vascular disorders
Raynaud's phenomenon
|
0.45%
2/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
Other adverse events
| Measure |
Nintedanib
n=444 participants at risk
Patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) who took part in the parent trials 1199.214 (Nintedanib or Placebo) or 1199-0340 (Nintedanib). Patients continued in this trial and received Nintedanib 150 mg (milligram) twice daily (bid) unless they had reduced their dose to 100 mg bid trial medication (Nintedanib or Placebo) in the parent trial.
Patients receiving 100 mg bid trial medication at the end of the parent trial could receive either Nintedanib 100 mg bid or 150 mg bid at the discretion of the investigator.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.4%
24/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.7%
52/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.4%
24/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
76.1%
338/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
9.7%
43/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Nausea
|
27.5%
122/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Vomiting
|
22.5%
100/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
General disorders
Fatigue
|
10.4%
46/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
General disorders
Pyrexia
|
6.3%
28/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Bronchitis
|
10.4%
46/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
COVID-19
|
15.3%
68/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Influenza
|
5.2%
23/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Nasopharyngitis
|
18.5%
82/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Respiratory tract infection
|
6.1%
27/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
17.1%
76/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Infections and infestations
Urinary tract infection
|
9.7%
43/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Investigations
Alanine aminotransferase increased
|
10.6%
47/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Investigations
Aspartate aminotransferase increased
|
9.7%
43/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.4%
33/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Investigations
Weight decreased
|
14.2%
63/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.4%
33/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.9%
75/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.2%
41/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.0%
31/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Nervous system disorders
Dizziness
|
5.4%
24/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Nervous system disorders
Headache
|
12.4%
55/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.7%
83/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.6%
47/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
24.8%
110/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
|
Vascular disorders
Hypertension
|
5.2%
23/444 • First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to ~59.9 months.
Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER