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| ID | Type | Description | Link |
|---|---|---|---|
| GA29989 | Other Identifier | Hoffmann-La Roche |
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To assess the safety of treatment with pirfenidone (up to 3600 mg/d) in patients with pulmonary fibrosis/idiopathic pulmonary fibrosis (PF/IPF).
This study has been designed as a rollover study to collectively include safety data from various previous studies.
In addition, InterMune has also initiated an Early Access Program to make pirfenidone available to a limited number of patients with idiopathic pulmonary fibrosis in the United States. This program is also being conducted under this protocol. Registration of patients with documented IPF has been closed as of October 2005.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pirfenidone | Experimental | up to 3600 mg/day of pirfenidone given orally administered in divided doses three times daily with food, for the duration of the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pirfenidone | Drug | up to 3600 mg/day of pirfenidone given orally administered in divided doses three times daily with food, for the duration of the study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Treatment-Emergent Adverse Event (AE), Serious AE (SAE), Severe AE, Life-threatening AE, Death or Discontinuation Because of an AE | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were classified as severe (Grade 3) in following cases: marked limitation in activity; some assistance usually required; medical intervention/ therapy required, hospitalization possible. Treatment-emergent AEs were those occurring on or after the first dosing day and up to 28 days after discontinuation of study treatment, and those occurring before treatment that worsened after the first study dose. AE included serious as well as non-serious AEs. | Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Predicted Forced Vital Capacity (FVC) | FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out from the lungs after full inspiration in the upright position, measured in liters. Predicted FVC is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (actual FVC value in liter)/(predicted FVC) * 100% |
Not provided
General Inclusion Criteria:
Roll-Over Criteria:
Criteria for Early Access Program patients:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | 85006 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32026243 | Derived | Gotfried MH, Girod CE, Antin-Ozerkis D, Burgess T, Strombom I, Stauffer JL, Kirchgaessler KU, Padilla ML. An Open-Label, Phase II Study of the Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (PIPF-002). Pulm Ther. 2018 Jun;4(1):59-71. doi: 10.1007/s41030-018-0053-y. Epub 2018 Apr 5. |
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Participants could enroll from Study PIPF-001 (a double-blind comparison of pirfenidone and prednisone in pulmonary fibrosis); individual-patient protocols (IPPs); investigator-sponsored Investigational New Drug applications (INDs) in idiopathic pulmonary fibrosis (IPF); and via an early access program (EAP) for participants with IPF.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pirfenidone | Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 milligram per day (mg/d). At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose greater than (>) 4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
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Not provided
| Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480 |
| Hemoglobin (Hgb)-Corrected Percent-Predicted Carbon Monoxide Diffusing Capacity (DLco) | DLco is a pulmonary function test, and measures the partial pressure difference between inspired and expired carbon monoxide. Predicted DLco is based on a formula using sex, age and height of a person. Predicted DLco = [Hbg-corrected DLco value (in milliliters per minute per millimeter mercury [mL/min/mmHg])/predicted DLco] * 100% | Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480 |
| Resting Oxygen Saturation by Pulse Oximetry (SpO2) | SpO2 is the percentage of oxygen saturation in the blood. Oxygen level (oxygen saturation) of the blood was measured using pulse oximetry on room air. | Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480 |
| Overall Survival | Survival was analyzed as time from first study dose to death (all-cause mortality) with surviving participants censored at their last available assessment. | First dosing of study treatment until death (up to 604 weeks) |
| Pomona |
| California |
| 91767 |
| United States |
| San Jose | California | 95119 | United States |
| New Haven | Connecticut | 06520 | United States |
| Sarasota | Florida | 34239 | United States |
| Atlanta | Georgia | 30322 | United States |
| Kailua | Hawaii | 96734 | United States |
| Lahaina | Hawaii | 96761 | United States |
| Nampa | Idaho | 83686 | United States |
| Elk Grove Village | Illinois | 60007 | United States |
| Boston | Massachusetts | 02118 | United States |
| West Roxbury | Massachusetts | 02132 | United States |
| St Louis | Missouri | 63110 | United States |
| Huntington Station | New York | 11746 | United States |
| New York | New York | 10016 | United States |
| New York | New York | 10029-6574 | United States |
| Rochester | New York | 14620 | United States |
| Worthington | Ohio | 43085 | United States |
| Portland | Oregon | 97220 | United States |
| Portland | Oregon | 97227 | United States |
| Lancaster | Pennsylvania | 17601 | United States |
| Dallas | Texas | 75390-8503 | United States |
| Houston | Texas | 77005 | United States |
| San Antonio | Texas | 78229 | United States |
| Provo | Utah | 84604 | United States |
| Annandale | Virginia | 22003 | United States |
| Bremerton | Washington | 98310 - 3349 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All treated participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pirfenidone | Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose >4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Percentage of Participants With a Treatment-Emergent Adverse Event (AE), Serious AE (SAE), Severe AE, Life-threatening AE, Death or Discontinuation Because of an AE | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were classified as severe (Grade 3) in following cases: marked limitation in activity; some assistance usually required; medical intervention/ therapy required, hospitalization possible. Treatment-emergent AEs were those occurring on or after the first dosing day and up to 28 days after discontinuation of study treatment, and those occurring before treatment that worsened after the first study dose. AE included serious as well as non-serious AEs. | All treated participants | Posted | Number | percentage of participants | Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks) |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percent Predicted Forced Vital Capacity (FVC) | FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out from the lungs after full inspiration in the upright position, measured in liters. Predicted FVC is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (actual FVC value in liter)/(predicted FVC) * 100% | All treated participants. "n" = participants who were evaluable for specified time point. | Posted | Mean | Standard Deviation | percent predicted FVC | Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Hemoglobin (Hgb)-Corrected Percent-Predicted Carbon Monoxide Diffusing Capacity (DLco) | DLco is a pulmonary function test, and measures the partial pressure difference between inspired and expired carbon monoxide. Predicted DLco is based on a formula using sex, age and height of a person. Predicted DLco = [Hbg-corrected DLco value (in milliliters per minute per millimeter mercury [mL/min/mmHg])/predicted DLco] * 100% | All treated participants. "n" = participants who were evaluable for specified time point. | Posted | Mean | Standard Deviation | percent predicted DLco | Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Resting Oxygen Saturation by Pulse Oximetry (SpO2) | SpO2 is the percentage of oxygen saturation in the blood. Oxygen level (oxygen saturation) of the blood was measured using pulse oximetry on room air. | All treated participants. "n" = participants who were evaluable for specified time point. | Posted | Mean | Standard Deviation | percentage of oxygen saturation | Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Survival was analyzed as time from first study dose to death (all-cause mortality) with surviving participants censored at their last available assessment. | All treated participants | Posted | Median | 95% Confidence Interval | weeks | First dosing of study treatment until death (up to 604 weeks) |
|
|
Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pirfenidone | Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose >4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study. | 49 | 83 | 81 | 83 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Abdominal strangulated hernia | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Oesophageal disorder | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Chest injury | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Starvation | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Non-systematic Assessment |
| |
| Lung squamous cell carcinoma stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Non-systematic Assessment |
| |
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Non-systematic Assessment |
| |
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Non-systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Non-systematic Assessment |
| |
| Autonomic nervous system imbalance | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Pulmonary alveolar haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Stomach discomfort | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| D011658 | Pulmonary Fibrosis |
| D012140 | Respiratory Tract Diseases |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C093844 | pirfenidone |
Not provided
Not provided
Not provided
| Title | Measurements |
|---|
|
| Life-threatening AE |
|
| AEs leading to death |
|
| AE leading to study treatment discontinuation |
|
|
|
|
|