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Clinical Trial Results:
An Open-Label Extension Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF)

Summary
EudraCT number	2007-007800-13
Trial protocol	IE GB DE FR BE ES IT
Global end of trial date	11 Feb 2016

Results information
Results version number	v1(current)
This version publication date	04 Mar 2017
First version publication date	04 Mar 2017
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

GA29960

ISRCTN number

-

US NCT number

NCT00662038

WHO universal trial number (UTN)

-

Other trial identifiers

Alternate study identifier: PIPF-012

Sponsor organisation name

Hoffmann-La Roche

Sponsor organisation address

Grenzacherstrasse 124, Basel, Switzerland, CH-4070

Public contact

Medical Communications, Hoffmann-La Roche, +1 800 8218590, genentech@druginfo.com

Scientific contact

Medical Communications, Hoffmann-La Roche, +1 800 8218590, genentech@druginfo.com

Is trial part of an agreed paediatric investigation plan (PIP)

No

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Analysis stage

Final

Date of interim/final analysis

17 Oct 2016

Is this the analysis of the primary completion data?

Yes

Primary completion date

11 Feb 2016

Global end of trial reached?

Yes

Global end of trial date

11 Feb 2016

Was the trial ended prematurely?

No

Main objective of the trial

The trial objective was to obtain additional safety data for pirfenidone 2403 mg/d in subjects with idiopathic pulmonary fibrosis (IPF) who completed either Study PIPF-004 or PIPF-006.

Protection of trial subjects

Each subject, or the subject's representative, signed an informed consent form prior to screening.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

02 Sep 2008

Long term follow-up planned

Yes

Long term follow-up rationale

Safety

Long term follow-up duration

90 Months

Independent data monitoring committee (IDMC) involvement?

No

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 759

Country: Number of subjects enrolled

Australia: 63

Country: Number of subjects enrolled

Belgium: 5

Country: Number of subjects enrolled

Brazil: 24

Country: Number of subjects enrolled

Canada: 32

Country: Number of subjects enrolled

France: 10

Country: Number of subjects enrolled

Germany: 18

Country: Number of subjects enrolled

Israel: 15

Country: Number of subjects enrolled

Italy: 43

Country: Number of subjects enrolled

Mexico: 16

Country: Number of subjects enrolled

New Zealand: 3

Country: Number of subjects enrolled

Peru: 36

Country: Number of subjects enrolled

Poland: 9

Country: Number of subjects enrolled

Singapore: 1

Country: Number of subjects enrolled

Spain: 14

Country: Number of subjects enrolled

United Kingdom: 10

Worldwide total number of subjects

1058

EEA total number of subjects

109

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

313

From 65 to 84 years

745

85 years and over

0

Subject disposition

Top of page

Recruitment details

-

Screening details

A total of 1058 subjects enrolled from Studies PIPF-004/006/016.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Pirfenidone

Arm description

Pirfenidone, 2403 mg/d, administered as 801-mg doses, three times daily.

Arm type

Experimental

Investigational medicinal product name

Pirfenidone

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Pirfenidone, 2403 milligrams per day (mg/d), administered as 801 mg doses, three times daily.

Number of subjects in period 1	Pirfenidone
Started	1058
Completed	427
Not completed	631
Adverse event, serious fatal	95
Consent withdrawn by subject	83
Physician decision	19
Adverse event, non-fatal	358
Lung transplantation	44
Withdrawn consent	22
Reason not specified	3
Sponsor decision	1
Lost to follow-up	1
Continued treatment	5

Baseline characteristics

Top of page

Reporting group title

Pirfenidone

Reporting group description

Pirfenidone, 2403 mg/d, administered as 801-mg doses, three times daily.

Reporting group values	Pirfenidone	Total
Number of subjects	1058	1058
Age categorical
Units: Subjects
Adults (18-64 years)	313	313
Elderly (From 65-84 years)	745	745
Age Continuous
Units: years
arithmetic mean (standard deviation)	68.5 ( 7.47 )	-
Gender, Male/Female
Units: Subjects
Female	268	268
Male	790	790

End points

Top of page

Reporting group title

Pirfenidone

Reporting group description

Pirfenidone, 2403 mg/d, administered as 801-mg doses, three times daily.

Primary: Percentage of Subjects with Adverse Events

Top of page

End point title

Percentage of Subjects with Adverse Events ^[1]

End point description

An adverse event defined as any unfavorable, harmful, or pathologic change in a research subject administered a pharmaceutical study treatment as indicated by physical signs, symptoms, and/or clinically significant laboratory abnormalities that occurred during the treatment and the post-treatment period, regardless of suspected cause.

End point type

Primary

End point timeframe

7.5 years

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive analysis only.

End point values	Pirfenidone
Number of subjects analysed	1058
Units: percentage of subjects
number (not applicable)	98

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

7.5 years

Adverse event reporting additional description

Adverse events were recorded at every contact with the participant.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

11.0

Reporting group title

Pirfenidone

Reporting group description

Pirfenidone, 2403 mg/d, administered as 801 mg doses, three times daily.

Serious adverse events	Pirfenidone
Total subjects affected by serious adverse events
subjects affected / exposed	571 / 1058 (53.97%)
number of deaths (all causes)	231
number of deaths resulting from adverse events	13
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Benign ovarian tumour
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Bladder cancer
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Bladder cancer recurrent
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Breast cancer
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Breast cancer in situ
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Breast cancer metastatic
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Bronchial carcinoma
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Burkitt's lymphoma
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Chronic lymphocytic leukaemia
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Colon cancer
subjects affected / exposed	3 / 1058 (0.28%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 0
Colon cancer metastatic
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Gastric adenoma
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Gastrointestinal carcinoma
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Hepatic neoplasm
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Hepatic neoplasm malignant
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Intestinal adenocarcinoma
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Large cell carcinoma of the respiratory tract stage unspecified
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 1
Lung adenocarcinoma
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Lung adenocarcinoma Stage IV
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Lung cancer metastatic
subjects affected / exposed	6 / 1058 (0.57%)
occurrences causally related to treatment / all	0 / 6
deaths causally related to treatment / all	0 / 3
Lung neoplasm malignant
subjects affected / exposed	8 / 1058 (0.76%)
occurrences causally related to treatment / all	1 / 8
deaths causally related to treatment / all	1 / 3
Lung squamous cell carcinoma stage unspecified
subjects affected / exposed	8 / 1058 (0.76%)
occurrences causally related to treatment / all	1 / 9
deaths causally related to treatment / all	0 / 1
Lymphoma
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Malignant melanoma Stage I
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Malignant pleural effusion
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Metastases to bone
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Metastases to liver
subjects affected / exposed	3 / 1058 (0.28%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 0
Non-small cell lung cancer
subjects affected / exposed	5 / 1058 (0.47%)
occurrences causally related to treatment / all	0 / 5
deaths causally related to treatment / all	0 / 0
Non-small cell lung cancer metastatic
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Non-small cell lung cancer Stage IV
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Oesophageal adenocarcinoma metastatic
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Oesophageal cancer metastatic
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Ovarian cancer
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Ovarian cancer recurrent
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Pancreatic carcinoma metastatic
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Prostate cancer
subjects affected / exposed	3 / 1058 (0.28%)
occurrences causally related to treatment / all	1 / 3
deaths causally related to treatment / all	0 / 0
Prostate cancer metastatic
subjects affected / exposed	3 / 1058 (0.28%)
occurrences causally related to treatment / all	1 / 3
deaths causally related to treatment / all	0 / 0
Renal cancer
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Sarcoma
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Small cell carcinoma
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Small cell lung cancer stage unspecified
subjects affected / exposed	4 / 1058 (0.38%)
occurrences causally related to treatment / all	0 / 4
deaths causally related to treatment / all	0 / 1
Squamous cell carcinoma
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Vascular disorders
Air embolism
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Aortic aneurysm
subjects affected / exposed	4 / 1058 (0.38%)
occurrences causally related to treatment / all	0 / 4
deaths causally related to treatment / all	0 / 1
Aortic stenosis
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Arterial occlusive disease
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Deep vein thrombosis
subjects affected / exposed	7 / 1058 (0.66%)
occurrences causally related to treatment / all	0 / 7
deaths causally related to treatment / all	0 / 0
Arteriosclerosis
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Hypertension
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Embolism venous
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Hypertensive crisis
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Hypotension
subjects affected / exposed	7 / 1058 (0.66%)
occurrences causally related to treatment / all	0 / 7
deaths causally related to treatment / all	0 / 0
Orthostatic hypotension
subjects affected / exposed	3 / 1058 (0.28%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 0
Peripheral vascular disorder
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Shock
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Vasculitis necrotising
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
General disorders and administration site conditions
Asthenia
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Chest pain
subjects affected / exposed	15 / 1058 (1.42%)
occurrences causally related to treatment / all	0 / 16
deaths causally related to treatment / all	0 / 0
Death
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 2
Hypothermia
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Multi-organ failure
subjects affected / exposed	3 / 1058 (0.28%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 0
Non-cardiac chest pain
subjects affected / exposed	6 / 1058 (0.57%)
occurrences causally related to treatment / all	0 / 6
deaths causally related to treatment / all	0 / 0
Oedema peripheral
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Pyrexia
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Sudden death
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Systemic inflammatory response syndrome
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Immune system disorders
Anaphylactic reaction
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Anti-neutrophil cytoplasmic antibody positive vasculitis
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Polyarteritis nodosa
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Reproductive system and breast disorders
Benign prostatic hyperplasia
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	1 / 2
deaths causally related to treatment / all	0 / 0
Endometriosis
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Endosalpingiosis
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Female genital tract fistula
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Pelvic floor muscle weakness
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Prostatitis
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Acute respiratory distress syndrome
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Acute respiratory failure
subjects affected / exposed	30 / 1058 (2.84%)
occurrences causally related to treatment / all	5 / 30
deaths causally related to treatment / all	2 / 11
Alveolitis
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Bronchospasm
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Chronic obstructive pulmonary disease
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 0
Cough
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Dyspnoea
subjects affected / exposed	8 / 1058 (0.76%)
occurrences causally related to treatment / all	0 / 8
deaths causally related to treatment / all	0 / 0
Haemoptysis
subjects affected / exposed	3 / 1058 (0.28%)
occurrences causally related to treatment / all	1 / 3
deaths causally related to treatment / all	0 / 0
Haemothorax
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Hypoxia
subjects affected / exposed	17 / 1058 (1.61%)
occurrences causally related to treatment / all	1 / 18
deaths causally related to treatment / all	1 / 4
Idiopathic pulmonary fibrosis
subjects affected / exposed	230 / 1058 (21.74%)
occurrences causally related to treatment / all	9 / 276
deaths causally related to treatment / all	2 / 133
Increased bronchial secretion
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Interstitial lung disease
subjects affected / exposed	4 / 1058 (0.38%)
occurrences causally related to treatment / all	0 / 4
deaths causally related to treatment / all	0 / 1
Lung disorder
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Nasal discomfort
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Pleural effusion
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Pleurisy
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Pneumomediastinum
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Pneumonia aspiration
subjects affected / exposed	8 / 1058 (0.76%)
occurrences causally related to treatment / all	1 / 8
deaths causally related to treatment / all	0 / 1
Pneumonitis
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Pneumothorax
subjects affected / exposed	8 / 1058 (0.76%)
occurrences causally related to treatment / all	2 / 12
deaths causally related to treatment / all	0 / 0
Pneumothorax spontaneous tension
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Pulmonary arterial hypertension
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Pulmonary embolism
subjects affected / exposed	19 / 1058 (1.80%)
occurrences causally related to treatment / all	3 / 20
deaths causally related to treatment / all	0 / 0
Pulmonary cavitation
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Pulmonary haemorrhage
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Pulmonary hypertension
subjects affected / exposed	11 / 1058 (1.04%)
occurrences causally related to treatment / all	0 / 11
deaths causally related to treatment / all	0 / 2
Pulmonary mass
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Respiratory failure
subjects affected / exposed	29 / 1058 (2.74%)
occurrences causally related to treatment / all	4 / 29
deaths causally related to treatment / all	1 / 18
Sleep apnoea syndrome
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Psychiatric disorders
Anxiety
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Confusional state
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Depression
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Major depression
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Psychotic disorder
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Investigations
Hepatic enzyme increased
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	1 / 2
deaths causally related to treatment / all	0 / 0
Mycobacteria blood test positive
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Panel-reactive antibody increased
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 0
Pulmonary arterial pressure increased
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Troponin increased
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Tumour marker increased
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Injury, poisoning and procedural complications
Ankle fracture
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Burns second degree
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Cervical vertebral fracture
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Device lead damage
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Drug toxicity
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Extradural haematoma
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Facial bones fracture
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Failure of implant
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Fall
subjects affected / exposed	5 / 1058 (0.47%)
occurrences causally related to treatment / all	0 / 5
deaths causally related to treatment / all	0 / 0
Femur fracture
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Fractured coccyx
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Head injury
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Hip fracture
subjects affected / exposed	4 / 1058 (0.38%)
occurrences causally related to treatment / all	0 / 4
deaths causally related to treatment / all	0 / 0
Humerus fracture
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Incisional hernia, obstructive
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Injury
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Joint dislocation
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Lower limb fracture
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Lumbar vertebral fracture
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Patella fracture
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Post procedural complication
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Post procedural haemorrhage
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Radiation pneumonitis
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Renal haematoma
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Renal injury
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	1 / 2
deaths causally related to treatment / all	0 / 0
Rib fracture
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Road traffic accident
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Skeletal injury
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Skin laceration
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Spinal compression fracture
subjects affected / exposed	3 / 1058 (0.28%)
occurrences causally related to treatment / all	0 / 4
deaths causally related to treatment / all	0 / 0
Spinal cord injury
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Sternal fracture
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Struck by lightning
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Subdural haematoma
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Tendon rupture
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Ulna fracture
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Upper limb fracture
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Congenital, familial and genetic disorders
Gastrointestinal arteriovenous malformation
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Cardiac disorders
Acute coronary syndrome
subjects affected / exposed	7 / 1058 (0.66%)
occurrences causally related to treatment / all	0 / 7
deaths causally related to treatment / all	0 / 0
Acute myocardial infarction
subjects affected / exposed	12 / 1058 (1.13%)
occurrences causally related to treatment / all	0 / 12
deaths causally related to treatment / all	0 / 1
Acute right ventricular failure
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Angina pectoris
subjects affected / exposed	6 / 1058 (0.57%)
occurrences causally related to treatment / all	0 / 6
deaths causally related to treatment / all	0 / 0
Angina unstable
subjects affected / exposed	4 / 1058 (0.38%)
occurrences causally related to treatment / all	0 / 4
deaths causally related to treatment / all	0 / 0
Aortic valve stenosis
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Arrhythmia
subjects affected / exposed	3 / 1058 (0.28%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 3
Arteriosclerosis coronary artery
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Atrial fibrillation
subjects affected / exposed	26 / 1058 (2.46%)
occurrences causally related to treatment / all	1 / 32
deaths causally related to treatment / all	0 / 1
Atrial flutter
subjects affected / exposed	3 / 1058 (0.28%)
occurrences causally related to treatment / all	0 / 4
deaths causally related to treatment / all	0 / 0
Atrial tachycardia
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Atrioventricular block complete
subjects affected / exposed	3 / 1058 (0.28%)
occurrences causally related to treatment / all	1 / 3
deaths causally related to treatment / all	0 / 0
Atrioventricular block second degree
subjects affected / exposed	4 / 1058 (0.38%)
occurrences causally related to treatment / all	0 / 4
deaths causally related to treatment / all	0 / 0
Bradycardia
subjects affected / exposed	5 / 1058 (0.47%)
occurrences causally related to treatment / all	0 / 5
deaths causally related to treatment / all	0 / 0
Cardiac arrest
subjects affected / exposed	9 / 1058 (0.85%)
occurrences causally related to treatment / all	0 / 9
deaths causally related to treatment / all	0 / 6
Cardiac failure
subjects affected / exposed	5 / 1058 (0.47%)
occurrences causally related to treatment / all	0 / 5
deaths causally related to treatment / all	0 / 0
Cardiac failure acute
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Cardiac failure congestive
subjects affected / exposed	12 / 1058 (1.13%)
occurrences causally related to treatment / all	1 / 19
deaths causally related to treatment / all	1 / 2
Cardiomyopathy
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Cor pulmonale
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Coronary artery disease
subjects affected / exposed	20 / 1058 (1.89%)
occurrences causally related to treatment / all	0 / 20
deaths causally related to treatment / all	0 / 0
Coronary artery dissection
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Coronary artery occlusion
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Heart valve incompetence
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Ischaemic cardiomyopathy
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Left ventricular dysfunction
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Left ventricular failure
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Myocardial infarction
subjects affected / exposed	7 / 1058 (0.66%)
occurrences causally related to treatment / all	1 / 7
deaths causally related to treatment / all	1 / 3
Myocardial ischaemia
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 1
Palpitations
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Pericardial effusion
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Right ventricular dysfunction
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Right ventricular failure
subjects affected / exposed	4 / 1058 (0.38%)
occurrences causally related to treatment / all	0 / 4
deaths causally related to treatment / all	0 / 0
Sick sinus syndrome
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Sinus bradycardia
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Supraventricular tachycardia
subjects affected / exposed	3 / 1058 (0.28%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 0
Tachycardia
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Ventricular extrasystoles
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Ventricular tachycardia
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Nervous system disorders
Anoxic encephalopathy
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Brain stem infarction
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Carotid artery stenosis
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Central nervous system lesion
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Cerebral haematoma
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Cerebral infarction
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Cerebral ischaemia
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Cerebral thrombosis
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Cerebrovascular accident
subjects affected / exposed	14 / 1058 (1.32%)
occurrences causally related to treatment / all	3 / 16
deaths causally related to treatment / all	1 / 4
Chronic inflammatory demyelinating polyradiculoneuropathy
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Convulsion
subjects affected / exposed	3 / 1058 (0.28%)
occurrences causally related to treatment / all	1 / 3
deaths causally related to treatment / all	0 / 0
Demyelinating polyneuropathy
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Dizziness
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Embolic stroke
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Hemiparesis
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Hypoaesthesia
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Ischaemic stroke
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Mononeuropathy multiplex
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Neuropathy peripheral
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Paraparesis
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Spinal cord compression
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Syncope
subjects affected / exposed	20 / 1058 (1.89%)
occurrences causally related to treatment / all	2 / 26
deaths causally related to treatment / all	0 / 0
Syncope vasovagal
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Tension headache
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Thalamic infarction
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Transient ischaemic attack
subjects affected / exposed	8 / 1058 (0.76%)
occurrences causally related to treatment / all	1 / 8
deaths causally related to treatment / all	0 / 0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	5 / 1058 (0.47%)
occurrences causally related to treatment / all	0 / 5
deaths causally related to treatment / all	0 / 0
Coagulopathy
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Haemorrhagic anaemia
subjects affected / exposed	3 / 1058 (0.28%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 0
Iron deficiency anaemia
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Leukopenia
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Pancytopenia
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Thrombocytopenia
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Ear and labyrinth disorders
Vertigo
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Vertigo positional
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Eye disorders
Eye disorder
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Retinal detachment
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Gastrointestinal disorders
Abdominal adhesions
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Colitis ischaemic
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Colonic fistula
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Colonic polyp
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Constipation
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Diverticulum
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	1 / 2
deaths causally related to treatment / all	0 / 0
Diverticulum intestinal haemorrhagic
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Enteritis
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Gastric ulcer
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Gastritis
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Gastrointestinal haemorrhage
subjects affected / exposed	5 / 1058 (0.47%)
occurrences causally related to treatment / all	1 / 5
deaths causally related to treatment / all	0 / 0
Gastrointestinal necrosis
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Gastrooesophageal reflux disease
subjects affected / exposed	3 / 1058 (0.28%)
occurrences causally related to treatment / all	1 / 3
deaths causally related to treatment / all	0 / 0
Haematochezia
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Haemorrhoidal haemorrhage
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Haemorrhoids
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Hiatus hernia
subjects affected / exposed	3 / 1058 (0.28%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 0
Ileus
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Inguinal hernia
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Inguinal hernia strangulated
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Intestinal obstruction
subjects affected / exposed	3 / 1058 (0.28%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 0
Intra-abdominal haematoma
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Jejunal perforation
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Lower gastrointestinal haemorrhage
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Mesenteric vein thrombosis
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Nausea
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Obstruction gastric
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Oesophageal perforation
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Pancreatitis
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	1 / 2
deaths causally related to treatment / all	0 / 0
Pancreatitis acute
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Peritonitis
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Rectal polyp
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Small intestinal obstruction
subjects affected / exposed	3 / 1058 (0.28%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 1
Small intestinal perforation
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Umbilical hernia, obstructive
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Upper gastrointestinal haemorrhage
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Vomiting
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	2 / 2
deaths causally related to treatment / all	0 / 0
Hepatobiliary disorders
Bile duct obstruction
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Bile duct stenosis
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Bile duct stone
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Biliary dyskinesia
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Cholangitis
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Cholecystitis
subjects affected / exposed	3 / 1058 (0.28%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 0
Cholecystitis acute
subjects affected / exposed	4 / 1058 (0.38%)
occurrences causally related to treatment / all	1 / 4
deaths causally related to treatment / all	0 / 0
Cholecystitis chronic
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Cholelithiasis
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	1 / 2
deaths causally related to treatment / all	0 / 0
Skin and subcutaneous tissue disorders
Eczema
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Hypoaesthesia facial
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Photosensitivity reaction
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Urticaria
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Renal and urinary disorders
Calculus ureteric
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Calculus urinary
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Glomerulonephritis rapidly progressive
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Haematuria
subjects affected / exposed	3 / 1058 (0.28%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 0
Nephrolithiasis
subjects affected / exposed	6 / 1058 (0.57%)
occurrences causally related to treatment / all	0 / 6
deaths causally related to treatment / all	0 / 0
Renal cyst
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Renal failure
subjects affected / exposed	4 / 1058 (0.38%)
occurrences causally related to treatment / all	0 / 4
deaths causally related to treatment / all	0 / 1
Renal failure acute
subjects affected / exposed	3 / 1058 (0.28%)
occurrences causally related to treatment / all	0 / 4
deaths causally related to treatment / all	0 / 0
Urinary retention
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Endocrine disorders
Adrenal mass
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Costochondritis
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Intervertebral disc degeneration
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Intervertebral disc disorder
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Intervertebral disc protrusion
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Lumbar spinal stenosis
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Muscle spasms
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Muscular weakness
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Musculoskeletal pain
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Neck pain
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Osteoarthritis
subjects affected / exposed	7 / 1058 (0.66%)
occurrences causally related to treatment / all	0 / 8
deaths causally related to treatment / all	0 / 0
Osteoporosis
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Polymyalgia rheumatica
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Spinal column stenosis
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Infections and infestations
Abdominal abscess
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Abscess intestinal
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Acute sinusitis
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Appendicitis
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Bacteraemia
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Bacterial abscess central nervous system
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Bartonellosis
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Bronchiectasis
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Bronchitis
subjects affected / exposed	32 / 1058 (3.02%)
occurrences causally related to treatment / all	0 / 38
deaths causally related to treatment / all	0 / 0
Bronchitis viral
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Bronchopneumonia
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Bronchopulmonary aspergillosis
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Bursitis infective
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Campylobacter intestinal infection
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Candidiasis
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Cellulitis
subjects affected / exposed	3 / 1058 (0.28%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 0
Cellulitis staphylococcal
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Clostridial infection
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Diverticulitis
subjects affected / exposed	4 / 1058 (0.38%)
occurrences causally related to treatment / all	2 / 5
deaths causally related to treatment / all	0 / 0
Endocarditis
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Endocarditis enterococcal
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Enterococcal bacteraemia
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Enterocolitis infectious
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Escherichia sepsis
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Fungal oesophagitis
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Gastroenteritis
subjects affected / exposed	3 / 1058 (0.28%)
occurrences causally related to treatment / all	2 / 3
deaths causally related to treatment / all	0 / 0
Herpes zoster
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Herpes zoster oticus
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Influenza
subjects affected / exposed	7 / 1058 (0.66%)
occurrences causally related to treatment / all	0 / 7
deaths causally related to treatment / all	0 / 0
Liver abscess
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Lobar pneumonia
subjects affected / exposed	4 / 1058 (0.38%)
occurrences causally related to treatment / all	1 / 5
deaths causally related to treatment / all	1 / 1
Lower respiratory tract infection
subjects affected / exposed	4 / 1058 (0.38%)
occurrences causally related to treatment / all	0 / 5
deaths causally related to treatment / all	0 / 0
Lower respiratory tract infection bacterial
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Lung infection
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 2
Lung infection pseudomonal
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Pneumocystis jiroveci pneumonia
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	1 / 1
Pneumonia
subjects affected / exposed	90 / 1058 (8.51%)
occurrences causally related to treatment / all	7 / 104
deaths causally related to treatment / all	1 / 10
Pneumonia bacterial
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Pneumonia herpes viral
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Pneumonia influenzal
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Pneumonia pneumococcal
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Pneumonia respiratory syncytial viral
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Pneumonia staphylococcal
subjects affected / exposed	4 / 1058 (0.38%)
occurrences causally related to treatment / all	0 / 4
deaths causally related to treatment / all	0 / 0
Pneumonia streptococcal
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Pneumonia viral
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Postoperative abscess
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Postoperative wound infection
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Pseudomembranous colitis
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	1 / 2
deaths causally related to treatment / all	0 / 0
Respiratory tract infection
subjects affected / exposed	3 / 1058 (0.28%)
occurrences causally related to treatment / all	0 / 4
deaths causally related to treatment / all	0 / 0
Sepsis
subjects affected / exposed	3 / 1058 (0.28%)
occurrences causally related to treatment / all	0 / 4
deaths causally related to treatment / all	0 / 0
Septic shock
subjects affected / exposed	3 / 1058 (0.28%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 0
Sinusitis
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Staphylococcal infection
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Upper respiratory tract infection
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Urinary tract infection
subjects affected / exposed	8 / 1058 (0.76%)
occurrences causally related to treatment / all	0 / 8
deaths causally related to treatment / all	0 / 0
Viral infection
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Metabolism and nutrition disorders
Cachexia
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	1 / 2
deaths causally related to treatment / all	0 / 0
Dehydration
subjects affected / exposed	6 / 1058 (0.57%)
occurrences causally related to treatment / all	1 / 7
deaths causally related to treatment / all	0 / 0
Diabetes mellitus inadequate control
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Hypochloraemia
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Hypokalaemia
subjects affected / exposed	2 / 1058 (0.19%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Hyponatraemia
subjects affected / exposed	4 / 1058 (0.38%)
occurrences causally related to treatment / all	0 / 4
deaths causally related to treatment / all	0 / 0
Hypovolaemia
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Metabolic acidosis
subjects affected / exposed	1 / 1058 (0.09%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Pirfenidone
Total subjects affected by non serious adverse events
subjects affected / exposed	1027 / 1058 (97.07%)
Investigations
Weight decreased
subjects affected / exposed	153 / 1058 (14.46%)
occurrences all number	173
Vascular disorders
Hypertension
subjects affected / exposed	71 / 1058 (6.71%)
occurrences all number	72
Nervous system disorders
Dizziness
subjects affected / exposed	176 / 1058 (16.64%)
occurrences all number	225
Headache
subjects affected / exposed	157 / 1058 (14.84%)
occurrences all number	248
Syncope
subjects affected / exposed	55 / 1058 (5.20%)
occurrences all number	65
General disorders and administration site conditions
Oedema peripheral
subjects affected / exposed	128 / 1058 (12.10%)
occurrences all number	159
Fatigue
subjects affected / exposed	210 / 1058 (19.85%)
occurrences all number	251
Asthenia
subjects affected / exposed	65 / 1058 (6.14%)
occurrences all number	72
Chest pain
subjects affected / exposed	64 / 1058 (6.05%)
occurrences all number	76
Pyrexia
subjects affected / exposed	60 / 1058 (5.67%)
occurrences all number	78
Eye disorders
Cataract
subjects affected / exposed	53 / 1058 (5.01%)
occurrences all number	67
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	60 / 1058 (5.67%)
occurrences all number	72
Abdominal pain upper
subjects affected / exposed	66 / 1058 (6.24%)
occurrences all number	84
Constipation
subjects affected / exposed	118 / 1058 (11.15%)
occurrences all number	142
Gastrooesophageal reflux disease
subjects affected / exposed	102 / 1058 (9.64%)
occurrences all number	112
Diarrhoea
subjects affected / exposed	242 / 1058 (22.87%)
occurrences all number	357
Dyspepsia
subjects affected / exposed	126 / 1058 (11.91%)
occurrences all number	150
Stomach discomfort
subjects affected / exposed	53 / 1058 (5.01%)
occurrences all number	73
Vomiting
subjects affected / exposed	122 / 1058 (11.53%)
occurrences all number	172
Nausea
subjects affected / exposed	305 / 1058 (28.83%)
occurrences all number	431
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	330 / 1058 (31.19%)
occurrences all number	435
Dyspnoea exertional
subjects affected / exposed	68 / 1058 (6.43%)
occurrences all number	69
Dyspnoea
subjects affected / exposed	325 / 1058 (30.72%)
occurrences all number	412
Epistaxis
subjects affected / exposed	64 / 1058 (6.05%)
occurrences all number	84
Idiopathic pulmonary fibrosis
subjects affected / exposed	221 / 1058 (20.89%)
occurrences all number	271
Hypoxia
subjects affected / exposed	73 / 1058 (6.90%)
occurrences all number	79
Productive cough
subjects affected / exposed	62 / 1058 (5.86%)
occurrences all number	75
Pharyngolaryngeal pain
subjects affected / exposed	71 / 1058 (6.71%)
occurrences all number	86
Nasal congestion
subjects affected / exposed	56 / 1058 (5.29%)
occurrences all number	64
Pulmonary hypertension
subjects affected / exposed	123 / 1058 (11.63%)
occurrences all number	128
Skin and subcutaneous tissue disorders
Photosensitivity reaction
subjects affected / exposed	74 / 1058 (6.99%)
occurrences all number	98
Pruritus
subjects affected / exposed	71 / 1058 (6.71%)
occurrences all number	82
Rash
subjects affected / exposed	156 / 1058 (14.74%)
occurrences all number	230
Psychiatric disorders
Anxiety
subjects affected / exposed	84 / 1058 (7.94%)
occurrences all number	89
Insomnia
subjects affected / exposed	111 / 1058 (10.49%)
occurrences all number	121
Depression
subjects affected / exposed	82 / 1058 (7.75%)
occurrences all number	85
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	146 / 1058 (13.80%)
occurrences all number	178
Arthralgia
subjects affected / exposed	89 / 1058 (8.41%)
occurrences all number	119
Pain in extremity
subjects affected / exposed	67 / 1058 (6.33%)
occurrences all number	82
Infections and infestations
Bronchitis
subjects affected / exposed	254 / 1058 (24.01%)
occurrences all number	447
Influenza
subjects affected / exposed	75 / 1058 (7.09%)
occurrences all number	94
Lower respiratory tract infection
subjects affected / exposed	67 / 1058 (6.33%)
occurrences all number	123
Respiratory tract infection
subjects affected / exposed	57 / 1058 (5.39%)
occurrences all number	69
Nasopharyngitis
subjects affected / exposed	202 / 1058 (19.09%)
occurrences all number	359
Pneumonia
subjects affected / exposed	88 / 1058 (8.32%)
occurrences all number	107
Urinary tract infection
subjects affected / exposed	103 / 1058 (9.74%)
occurrences all number	190
Upper respiratory tract infection
subjects affected / exposed	295 / 1058 (27.88%)
occurrences all number	522
Sinusitis
subjects affected / exposed	130 / 1058 (12.29%)
occurrences all number	218
Metabolism and nutrition disorders
Anorexia
subjects affected / exposed	120 / 1058 (11.34%)
occurrences all number	136
Decreased appetite
subjects affected / exposed	95 / 1058 (8.98%)
occurrences all number	103

More information

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Were there any global substantial amendments to the protocol? Yes

13 Sep 2010

Revised duration of treatment period; clarified dose escalation for subjects who required dose reduction while participating in Study PIPF-004; clarified exclusion criteria for QT corrected for heart rate using Bazett's method (QTcB); incorporated updated background information; revised windows for post-treatment follow-up visit and collection of concomitant medications; revised requirements for early withdrawal from study visit; corrected required visits for subjects who required restart visits.

07 Oct 2011

Allowed subjects from additional qualifying InterMune clinical studies to enroll (previously limited to subjects from Studies PIPF-004/006); eliminated efficacy assessments as of 15 May 2012; simplified and clarified the safety assessments as of 15 May 2012, as follows: revised prohibited prior and concomitant medications; eliminated exclusion criteria related to liver tests and electrocardiogram (ECG) results; eliminated subject diary; clarified dose-escalation guidelines, and revised dose-modification, interruption, and restart guidelines; clarified requirements for pre-restart and restart visits; updated adverse event reporting guidelines.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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