Roll Over Study From 1199.30 BIBF 1120 in Idiopathic Pulm... | NCT01170065

ID	Type	Description	Link
2009-013788-21	EudraCT Number

Label	Type	Description	Intervention Names
BIBF 1120 low qd	Experimental	Low dose BIBF 1120 once daily	Drug: BIBF 1120
BIBF 1120 low bid	Experimental	Low dose BIBF 1120 twice daily	Drug: BIBF 1120
BIBF 1120 medium bid	Experimental	Intermediate dose BIBF 1120 twice daily	Drug: BIBF 1120
BIBF 1120 high bid	Experimental	High dose BIBF 1120 twice daily	Drug: BIBF 1120

Name	Type	Description	Arm Group Labels	Other Names
BIBF 1120	Drug	Intermediate dose BIBF 1120 twice daily	BIBF 1120 medium bid

Measure	Description	Time Frame
Annual Rate of Decline in Forced Vital Capacity (FVC)	Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test. For this endpoint reported means represent the adjusted rate.	From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months

Measure	Description	Time Frame
Overall Survival	Overall survival is defined as the time from the first intake of nintedanib in trial 1199.35 to death. For presentation of overall survival results, Kaplan-Meier estimates and confidence intervals (using Greenwood variance formula) for the overall on-treatment survival is calculated within each treatment arm.	From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
INSARES		Mendoza		M5500CCG	Argentina
Respiratory Clinical Trial Pty Ltd.

PubMed Identifier	Type	Citation	Retractions
28993537	Derived	Richeldi L, Kreuter M, Selman M, Crestani B, Kirsten AM, Wuyts WA, Xu Z, Bernois K, Stowasser S, Quaresma M, Costabel U. Long-term treatment of patients with idiopathic pulmonary fibrosis with nintedanib: results from the TOMORROW trial and its open-label extension. Thorax. 2018 Jun;73(6):581-583. doi: 10.1136/thoraxjnl-2016-209701. Epub 2017 Oct 9.

ID	Title	Description
FG000	Placebo	Patients were treated with oral administration of placebo in period 1 of the parent trial and with soft gelatine capsules of Nintedanib 50 mg once daily (qd) in the second period of the 1199.30 (parent trial). In the 1199.35 trial they could remain on this last dose or increase to Nintedanib 150 mg twice daily (bid)
FG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Annual Rate of Decline in Forced Vital Capacity (FVC)

Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test.

For this endpoint reported means represent the adjusted rate.

The full analysis set (FAS): which included all patients in the treated set who provided baseline data (for the first trial visit) for at least 1 endpoint in trial 1199.35

Posted

Mean

Standard Error

milliliters per year (mL/ yr)

From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months

ID	Title	Description
OG000	Placebo	Patients were treated with oral administration of placebo in period 1 of the parent trial and with soft gelatine capsules of Nintedanib 50 mg once daily (qd) in the second period of the 1199.30 (parent trial). In the 1199.35 trial they could remain on this last dose or increase to Nintedanib 150 mg twice daily (bid)
OG001	Nintedanib 50 mg- 100 mg	Patients were treated with oral administration of soft gelatine capsules of Nintedanib 50 mg qd, 50 mg bid or 100 mg bid in the parent trial. In the 1199.35 trial they could remain on their last dose in the parent trial or increase to Nintedanib 150 mg bid.
OG002	Nintedanib 150 mg	Patients were treated with oral administration of soft gelatine capsules of Nintedanib 150 mg bid and could step down to 100 mg bid. In the 1199.35 trial they could remain on their last dose in the parent trial.

Units	Counts
Participants	OG00037 OG001126 OG00235

Title

Denominators

Categories

Title	Measurements
	OG000-129.0± 29.47 OG001-137.5± 14.60 OG002-132.9± 28.22

Secondary

Overall Survival

Overall survival is defined as the time from the first intake of nintedanib in trial 1199.35 to death.

For presentation of overall survival results, Kaplan-Meier estimates and confidence intervals (using Greenwood variance formula) for the overall on-treatment survival is calculated within each treatment arm.

FAS

Posted

Number

95% Confidence Interval

percentage of participants

From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months

ID	Title	Description
OG000	Placebo	Patients were treated with oral administration of placebo in period 1 of the parent trial and with soft gelatine capsules of Nintedanib 50 mg once daily (qd) in the second period of the 1199.30 (parent trial). In the 1199.35 trial they could remain on this last dose or increase to Nintedanib 150 mg twice daily (bid)
OG001	Nintedanib 50 mg- 100 mg	Patients were treated with oral administration of soft gelatine capsules of Nintedanib 50 mg qd, 50 mg bid or 100 mg bid in the parent trial. In the 1199.35 trial they could remain on their last dose in the parent trial or increase to Nintedanib 150 mg bid.
OG002	Nintedanib 150 mg	Patients were treated with oral administration of soft gelatine capsules of Nintedanib 150 mg bid and could step down to 100 mg bid. In the 1199.35 trial they could remain on their last dose in the parent trial.

Secondary

Progression-Free Survival

Progression-free survival was defined as the time from the first nintedanib intake in trial 1199.35 to disease progression.

For presentation of progression-free survival results, Kaplan-Meier estimates and confidence intervals (using Greenwood variance formula) for the overall on-treatment progression-free survival is calculated within each treatment arm.

FAS

Posted

Number

95% Confidence Interval

percentage of participants

From first trial drug intake in 1199.35 to disease progression; up to 61.8 months

ID	Title	Description
OG000	Placebo	Patients were treated with oral administration of placebo in period 1 of the parent trial and with soft gelatine capsules of Nintedanib 50 mg once daily (qd) in the second period of the 1199.30 (parent trial). In the 1199.35 trial they could remain on this last dose or increase to Nintedanib 150 mg twice daily (bid)
OG001	Nintedanib 50 mg- 100 mg	Patients were treated with oral administration of soft gelatine capsules of Nintedanib 50 mg qd, 50 mg bid or 100 mg bid in the parent trial. In the 1199.35 trial they could remain on their last dose in the parent trial or increase to Nintedanib 150 mg bid.
OG002	Nintedanib 150 mg

Secondary

Annual Rate of Decline in Haemoglobin Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) Decrease

Haemoglobin corrected DLCO decrease was a secondary endpoint for the trial. It was considered important that all investigators used the same method of testing and recording data at each visit for each patient.

Haemoglobin corrected DLCO was calculated for each patient using the following formulae:

Males: Hb corrected DLCO = measured DLCO x (10.22 + Hb concentration) / (1.7 x Hb concentration) Females: Hb corrected DLCO = measured DLCO x (9.38 + Hb concentration) / (1.7 x Hb concentration). Annual rate of decline in haemoglobin corrected diffusing capacity of the lung for carbon monoxide (DLCO) decrease is presented.

FAS

Posted

Mean

Standard Error

mmol/min/kPa/yr

From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months

ID	Title	Description
OG000	Placebo	Patients were treated with oral administration of placebo in period 1 of the parent trial and with soft gelatine capsules of Nintedanib 50 mg once daily (qd) in the second period of the 1199.30 (parent trial). In the 1199.35 trial they could remain on this last dose or increase to Nintedanib 150 mg twice daily (bid)
OG001	Nintedanib 50 mg- 100 mg	Patients were treated with oral administration of soft gelatine capsules of Nintedanib 50 mg qd, 50 mg bid or 100 mg bid in the parent trial. In the 1199.35 trial they could remain on their last dose in the parent trial or increase to Nintedanib 150 mg bid.

Secondary

Percentage of Patients With at Least One Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation

Percentage of patients with at least one acute idiopathic pulmonary fibrosis (IPF) exacerbation are presented.

An exacerbation was defined as otherwise unexplained clinical features occurring within

1 month including all of the following:

Progression of dyspnoea over several days to 4 weeks
New diffuse pulmonary infiltrates on chest X-ray and/or high-resolution computerised tomography (HRCT) Parenchymal abnormalities with no pneumothorax or pleural effusion (new ground-glass opacities) since the last visit
A decrease in arterial oxygen partial pressure (PaO2) of ≥10 mmHg or PaO2/fraction of inspired oxygen (FiO2) of <225 mmHg since the last visit
Exclusion of infection based on routine clinical practice and microbiological studies
Absence of other contributory causes such as congestive heart failure, pulmonary embolism, etc.

FAS

Posted

Number

Percentage of participants

From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months

ID	Title	Description
OG000	Placebo	Patients were treated with oral administration of placebo in period 1 of the parent trial and with soft gelatine capsules of Nintedanib 50 mg once daily (qd) in the second period of the 1199.30 (parent trial). In the 1199.35 trial they could remain on this last dose or increase to Nintedanib 150 mg twice daily (bid)
OG001	Nintedanib 50 mg- 100 mg

Secondary

Incidence of Patients With at Least One Acute IPF Exacerbation Over Time

Incidence rate = (Patients with at least one acute IPF exacerbation / Total number of years at risk) x 100

FAS

Posted

Number

Exacerbations Per Year

From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months

ID	Title	Description
OG000	Placebo	Patients were treated with oral administration of placebo in period 1 of the parent trial and with soft gelatine capsules of Nintedanib 50 mg once daily (qd) in the second period of the 1199.30 (parent trial). In the 1199.35 trial they could remain on this last dose or increase to Nintedanib 150 mg twice daily (bid)
OG001	Nintedanib 50 mg- 100 mg	Patients were treated with oral administration of soft gelatine capsules of Nintedanib 50 mg qd, 50 mg bid or 100 mg bid in the parent trial. In the 1199.35 trial they could remain on their last dose in the parent trial or increase to Nintedanib 150 mg bid.
OG002	Nintedanib 150 mg	Patients were treated with oral administration of soft gelatine capsules of Nintedanib 150 mg bid and could step down to 100 mg bid. In the 1199.35 trial they could remain on their last dose in the parent trial.

Secondary

Time to First Acute IPF Exacerbation

Due to rare events, the median of time to event is not calculable, thus Kaplan-Meier estimates (providing the percentage of patients without acute IPF exacerbation for a certain amount of time after treatment) and confidence intervals (using Greenwood variance formula) are reported and presented within each treatment arm as secondary endpoint.

FAS

Posted

Number

95% Confidence Interval

percentage of participants

From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months

ID	Title	Description
OG000	Placebo	Patients were treated with oral administration of placebo in period 1 of the parent trial and with soft gelatine capsules of Nintedanib 50 mg once daily (qd) in the second period of the 1199.30 (parent trial). In the 1199.35 trial they could remain on this last dose or increase to Nintedanib 150 mg twice daily (bid)
OG001	Nintedanib 50 mg- 100 mg	Patients were treated with oral administration of soft gelatine capsules of Nintedanib 50 mg qd, 50 mg bid or 100 mg bid in the parent trial. In the 1199.35 trial they could remain on their last dose in the parent trial or increase to Nintedanib 150 mg bid.
OG002	Nintedanib 150 mg

Secondary

Percentage of Patients With at Least One Adverse Events (AEs), With Investigator Defined Drug-Related AEs, AEs Leading to Discontinuation of Trial Drug, Serious AEs

Percentage of patients with at least one Adverse events (AEs), with investigator defined drug-related AEs, AEs leading to discontinuation of trial drug, serious AEs are presented

Posted

Number

Percentage of participants

From the first nintedanib intake in trial 1199.35 to the last nintedanib intake + 28 days; up to 61.8 months + 28 days

ID	Title	Description
OG000	Placebo	Patients were treated with oral administration of placebo in period 1 of the parent trial and with soft gelatine capsules of Nintedanib 50 mg once daily (qd) in the second period of the 1199.30 (parent trial). In the 1199.35 trial they could remain on this last dose or increase to Nintedanib 150 mg twice daily (bid)
OG001	Nintedanib 50 mg- 100 mg	Patients were treated with oral administration of soft gelatine capsules of Nintedanib 50 mg qd, 50 mg bid or 100 mg bid in the parent trial. In the 1199.35 trial they could remain on their last dose in the parent trial or increase to Nintedanib 150 mg bid.
OG002	Nintedanib 150 mg	Patients were treated with oral administration of soft gelatine capsules of Nintedanib 150 mg bid and could step down to 100 mg bid. In the 1199.35 trial they could remain on their last dose in the parent trial.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute coronary syndrome	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0021 affected35 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0013 affected126 at risk EG0020 affected35 at risk
Angina unstable	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0013 affected126 at risk EG0020 affected35 at risk
Arrhythmia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected37 at risk EG0010 affected126 at risk EG0020 affected35 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected37 at risk EG0012 affected126 at risk EG0020 affected35 at risk
Bradycardia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0010 affected126 at risk EG0021 affected35 at risk
Bundle branch block	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Cardiac arrest	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Cardiac disorder	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0010 affected126 at risk EG0022 affected35 at risk
Cardiac failure	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0015 affected126 at risk EG0021 affected35 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0010 affected126 at risk EG0021 affected35 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Coronary artery disease	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Myocardial infarction	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0012 affected126 at risk EG0021 affected35 at risk
Right ventricular failure	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0012 affected126 at risk EG0020 affected35 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected37 at risk EG0010 affected126 at risk EG0020 affected35 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected37 at risk EG0012 affected126 at risk EG0021 affected35 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected37 at risk EG0010 affected126 at risk EG0020 affected35 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0021 affected35 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0010 affected126 at risk EG0021 affected35 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Nausea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected37 at risk EG0010 affected126 at risk EG0020 affected35 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0012 affected126 at risk EG0020 affected35 at risk
Volvulus	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Vomiting	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected37 at risk EG0010 affected126 at risk EG0020 affected35 at risk
Chest pain	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected37 at risk EG0012 affected126 at risk EG0021 affected35 at risk
Death	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Disease progression	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0012 affected126 at risk EG0020 affected35 at risk
General physical health deterioration	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Impaired healing	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0010 affected126 at risk EG0021 affected35 at risk
Multi-organ failure	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Pyrexia	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Sudden death	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0012 affected126 at risk EG0020 affected35 at risk
Bacterial infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0010 affected126 at risk EG0021 affected35 at risk
Bronchitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected37 at risk EG0013 affected126 at risk EG0021 affected35 at risk
Bronchopneumonia	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0010 affected126 at risk EG0021 affected35 at risk
Chlamydial infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Fungal infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0010 affected126 at risk EG0021 affected35 at risk
Gastroenteritis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Gastroenteritis clostridial	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected37 at risk EG0010 affected126 at risk EG0020 affected35 at risk
Herpes zoster	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0010 affected126 at risk EG0021 affected35 at risk
Influenza	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0014 affected126 at risk EG0021 affected35 at risk
Lower respiratory tract infection bacterial	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0021 affected35 at risk
Lung infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected37 at risk EG0015 affected126 at risk EG0023 affected35 at risk
Pneumonia	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0003 affected37 at risk EG0016 affected126 at risk EG0022 affected35 at risk
Pneumonia escherichia	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Respiratory tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected37 at risk EG0014 affected126 at risk EG0021 affected35 at risk
Sepsis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Septic shock	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Urinary tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected37 at risk EG0010 affected126 at risk EG0020 affected35 at risk
Urosepsis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected37 at risk EG0010 affected126 at risk EG0020 affected35 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected37 at risk EG0010 affected126 at risk EG0020 affected35 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0003 affected37 at risk EG0012 affected126 at risk EG0021 affected35 at risk
Gastrointestinal stoma complication	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0010 affected126 at risk EG0021 affected35 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0010 affected126 at risk EG0021 affected35 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Pancreatic enzymes increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Troponin I	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Weight decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected37 at risk EG0012 affected126 at risk EG0020 affected35 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected37 at risk EG0010 affected126 at risk EG0020 affected35 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0010 affected126 at risk EG0021 affected35 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0012 affected126 at risk EG0020 affected35 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0002 affected37 at risk EG0012 affected126 at risk EG0020 affected35 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected37 at risk EG0012 affected126 at risk EG0020 affected35 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0010 affected126 at risk EG0021 affected35 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0013 affected126 at risk EG0020 affected35 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Cerebral infarction	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0010 affected126 at risk EG0021 affected35 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0021 affected35 at risk
Coma	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Dizziness	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Epilepsy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0010 affected126 at risk EG0021 affected35 at risk
Hemiplegia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0010 affected126 at risk EG0021 affected35 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Loss of consciousness	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected37 at risk EG0010 affected126 at risk EG0020 affected35 at risk
Syncope	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0013 affected126 at risk EG0020 affected35 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0010 affected126 at risk EG0021 affected35 at risk
Tremor	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected37 at risk EG0010 affected126 at risk EG0020 affected35 at risk
Depression	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Suicide attempt	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Haematuria	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected37 at risk EG0010 affected126 at risk EG0020 affected35 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0012 affected126 at risk EG0020 affected35 at risk
Urinary bladder polyp	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0010 affected126 at risk EG0021 affected35 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected37 at risk EG0012 affected126 at risk EG0020 affected35 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Bronchostenosis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Bullous lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected37 at risk EG00111 affected126 at risk EG0020 affected35 at risk
Hypoventilation	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Idiopathic pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG00011 affected37 at risk EG00141 affected126 at risk EG00210 affected35 at risk
Lung consolidation	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0021 affected35 at risk
Pneumomediastinum	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0010 affected126 at risk EG0021 affected35 at risk
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Pulmonary arterial hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0010 affected126 at risk EG0021 affected35 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected37 at risk EG0016 affected126 at risk EG0021 affected35 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected37 at risk EG0010 affected126 at risk EG0020 affected35 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0015 affected126 at risk EG0021 affected35 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected37 at risk EG0010 affected126 at risk EG0020 affected35 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected37 at risk EG0017 affected126 at risk EG0021 affected35 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Granuloma skin	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Aortic aneurysm	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0010 affected126 at risk EG0021 affected35 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Hypertension	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0021 affected35 at risk
Hypotension	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected37 at risk EG0010 affected126 at risk EG0020 affected35 at risk
Peripheral artery aneurysm	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected37 at risk EG0011 affected126 at risk EG0022 affected35 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0022 affected35 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected37 at risk EG0011 affected126 at risk EG0020 affected35 at risk
Cataract	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected37 at risk EG0019 affected126 at risk EG0023 affected35 at risk
Glaucoma	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0022 affected35 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected37 at risk EG0019 affected126 at risk EG0024 affected35 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected37 at risk EG0014 affected126 at risk EG0020 affected35 at risk
Constipation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected37 at risk EG00111 affected126 at risk EG0021 affected35 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG00019 affected37 at risk EG00168 affected126 at risk EG00222 affected35 at risk
Frequent bowel movements	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected37 at risk EG0010 affected126 at risk EG0022 affected35 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected37 at risk EG0014 affected126 at risk EG0022 affected35 at risk
Nausea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0009 affected37 at risk EG00122 affected126 at risk EG0022 affected35 at risk
Vomiting	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0007 affected37 at risk EG00117 affected126 at risk EG0023 affected35 at risk
Chest pain	General disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected37 at risk EG00110 affected126 at risk EG0021 affected35 at risk
Condition aggravated	General disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected37 at risk EG0010 affected126 at risk EG0021 affected35 at risk
Fatigue	General disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected37 at risk EG0019 affected126 at risk EG0024 affected35 at risk
Influenza like illness	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0010 affected126 at risk EG0022 affected35 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected37 at risk EG0012 affected126 at risk EG0022 affected35 at risk
Bronchitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG00012 affected37 at risk EG00127 affected126 at risk EG0026 affected35 at risk
Cystitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 affected37 at risk EG0012 affected126 at risk EG0021 affected35 at risk
Gastroenteritis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0018 affected126 at risk EG0024 affected35 at risk
Influenza	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected37 at risk EG0019 affected126 at risk EG0026 affected35 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0004 affected37 at risk EG00112 affected126 at risk EG0021 affected35 at risk
Nasopharyngitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0008 affected37 at risk EG00124 affected126 at risk EG0026 affected35 at risk
Pneumonia	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 affected37 at risk EG0013 affected126 at risk EG0021 affected35 at risk
Respiratory tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0003 affected37 at risk EG0018 affected126 at risk EG0023 affected35 at risk
Sinusitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0019 affected126 at risk EG0020 affected35 at risk
Tinea pedis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0010 affected126 at risk EG0022 affected35 at risk
Tooth abscess	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 affected37 at risk EG0012 affected126 at risk EG0020 affected35 at risk
Tracheobronchitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 affected37 at risk EG0012 affected126 at risk EG0022 affected35 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected37 at risk EG00110 affected126 at risk EG0021 affected35 at risk
Urinary tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 affected37 at risk EG00111 affected126 at risk EG0021 affected35 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0002 affected37 at risk EG0016 affected126 at risk EG0020 affected35 at risk
Hepatic enzyme increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0002 affected37 at risk EG0013 affected126 at risk EG0020 affected35 at risk
Weight decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG00010 affected37 at risk EG00129 affected126 at risk EG0027 affected35 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0006 affected37 at risk EG00117 affected126 at risk EG0022 affected35 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected37 at risk EG0013 affected126 at risk EG0022 affected35 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0010 affected126 at risk EG0022 affected35 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected37 at risk EG0014 affected126 at risk EG0021 affected35 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected37 at risk EG00110 affected126 at risk EG0021 affected35 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected37 at risk EG0012 affected126 at risk EG0021 affected35 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0022 affected35 at risk
Dizziness	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected37 at risk EG00111 affected126 at risk EG0022 affected35 at risk
Paraesthesia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0022 affected35 at risk
Sciatica	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0011 affected126 at risk EG0023 affected35 at risk
Anxiety	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0014 affected126 at risk EG0023 affected35 at risk
Depression	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected37 at risk EG0014 affected126 at risk EG0021 affected35 at risk
Insomnia	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0012 affected126 at risk EG0022 affected35 at risk
Haematuria	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0013 affected126 at risk EG0022 affected35 at risk
Proteinuria	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected37 at risk EG0012 affected126 at risk EG0022 affected35 at risk
Urinary retention	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0010 affected126 at risk EG0022 affected35 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected37 at risk EG00127 affected126 at risk EG0024 affected35 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0005 affected37 at risk EG00119 affected126 at risk EG0023 affected35 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected37 at risk EG0018 affected126 at risk EG0021 affected35 at risk
Idiopathic pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG00122 affected126 at risk EG0023 affected35 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected37 at risk EG0017 affected126 at risk EG0022 affected35 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected37 at risk EG0013 affected126 at risk EG0020 affected35 at risk
Hypertension	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0017 affected126 at risk EG0023 affected35 at risk
Hypotension	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected37 at risk EG0013 affected126 at risk EG0022 affected35 at risk

ID	Term
D017563	Lung Diseases, Interstitial
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
BG000	Placebo	Patients were treated with oral administration of placebo in period 1 of the parent trial and with soft gelatine capsules of Nintedanib 50 mg once daily (qd) in the second period of the 1199.30 (parent trial). In the 1199.35 trial they could remain on this last dose or increase to Nintedanib 150 mg twice daily (bid)
BG001	Nintedanib 50 mg- 100 mg	Patients were treated with oral administration of soft gelatine capsules of Nintedanib 50 mg qd, 50 mg bid or 100 mg bid in the parent trial. In the 1199.35 trial they could remain on their last dose in the parent trial or increase to Nintedanib 150 mg bid.
BG002	Nintedanib 150 mg	Patients were treated with oral administration of soft gelatine capsules of Nintedanib 150 mg bid and could step down to 100 mg bid. In the 1199.35 trial they could remain on their last dose in the parent trial.
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Patients were treated with oral administration of placebo in period 1 of the parent trial and with soft gelatine capsules of Nintedanib 50 mg once daily (qd) in the second period of the 1199.30 (parent trial). In the 1199.35 trial they could remain on this last dose or increase to Nintedanib 150 mg twice daily (bid)	25	37	34	37
EG001	Nintedanib 50 mg- 100 mg	Patients were treated with oral administration of soft gelatine capsules of Nintedanib 50 mg qd, 50 mg bid or 100 mg bid in the parent trial. In the 1199.35 trial they could remain on their last dose in the parent trial or increase to Nintedanib 150 mg bid.	94	126	111	126
EG002	Nintedanib 150 mg	Patients were treated with oral administration of soft gelatine capsules of Nintedanib 150 mg bid and could step down to 100 mg bid. In the 1199.35 trial they could remain on their last dose in the parent trial.	22	35	32	35