Evaluation of Efficacy and Safety of Roxadustat for the Treatment of Chemotherapy Induced Anemia

• Sponsor: FibroGen (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04076943
• Collaborator: AstraZeneca (Industry), Astellas Pharma Inc (Industry)
• Enrollment: 92
• Locations: 15
• Arm: 1
• Actual Duration (Months): 20.1
• Patients Per Site: 6.1
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of this study is to find out if roxadustat (also known as FG-4592) is safe and effective for the treatment of anemia in participants receiving chemotherapy treatment for cancer.

Condition or Disease	Intervention/Treatment	Phase
Chemotherapy Induced Anemia	Drug: Roxadustat	Phase 2

Detailed Description

This study consists of three periods:

1. Screening Period up to 28 days

2. Treatment Period of up to16 weeks

3. A Follow-up period of 4 weeks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 92 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Open Label Study Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Patients Receiving Chemotherapy Treatment for Non-Myeloid Malignancies
• Actual Study Start Date: Aug 20, 2019
• Actual Primary Completion Date: Mar 26, 2021
• Actual Study Completion Date: Apr 23, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Roxadustat Participants will receive roxadustat as an oral tablet, 3 times per week (TIW) for up to a maximum of 16 weeks.	Drug: Roxadustat; Roxadustat will be administered per schedule specified in the arm description.; Other Names: FG-4592

Outcome Measures

Primary Outcome Measures

1. Maximum Change in Hb Within 16 Weeks From Baseline Without Red Blood Cell (RBC) Transfusion [Baseline, up to Week 16]

   Baseline Hb was defined as the mean of the assessments from central lab prior to first dose of the study treatment, which included up to 2 latest screening values prior to Day 1 and a value on Day 1. All central lab assessments from Day 1 to end of treatment (EOT) or early termination (ET) were included in the evaluation of this endpoint. Hb values within 4 weeks after an RBC transfusion were excluded.

Secondary Outcome Measures

1. Mean Change in Hb Level From Baseline to Week 16 (Without RBC Transfusion) [Baseline, Week 16]

   Baseline Hb was defined as the mean of the assessments from central lab prior to first dose of the study treatment, which included up to 2 latest screening values prior to Day 1 and a value on Day 1. Mean Hb during treatment was computed using the mean area-under-the-curve trapezoid method, from Day 1 to EOT or ET Hb assessment.

2. Change in Hb From Baseline at Weeks 9, 13, and 16 (Without RBC Transfusion) [Baseline, Weeks 9, 13, and 16]

   Baseline Hb was defined as the mean of the assessments from central lab prior to first dose of the study treatment, which included up to 2 latest screening values prior to Day 1 and a value on Day 1.

3. Percentage of Participants Who Achieved a ≥1 g/dL Increase in Hb From Baseline Through Week 16 [Baseline through Week 16]

   The 95% confidence interval (CI) was based on the exact method of Clopper-Pearson method. All central lab assessments from Day 1 to EOT or ET were included in the analysis. Hb values within 4 weeks after an RBC transfusion was excluded.

4. Time to Achieve a ≥1 g/dL Increase in Hb From Baseline Through Week 16 [Baseline through Week 16]

   Median was calculated using Kaplan-Meier product limit method. 95% CI was calculated using the method of Brookmeyer and Crowley. All central lab assessments from Day 1 to EOT or ET were included in the analysis. Hb values within 4 weeks after an RBC transfusion were excluded.

5. Percentage of Participants Who Achieved a ≥1.5 g/dL Increase in Hb From Baseline Through Week 16 [Baseline through Week 16]

   The 95% CI was based on the exact method of Clopper-Pearson method. All central lab assessments from Day 1 to EOT or ET were included in the analysis. Hb values within 4 weeks after an RBC transfusion was excluded.

6. Percentage of Participants Who Achieved a Hematopoietic Response [Baseline through Week 16]

   Hematopoietic response was defined as an increase in Hb of 1.5 g/dL from baseline or attaining a Hb of 11 g/dL. The 95% CI was based on the exact method of Clopper-Pearson method. All central lab assessments from Day 1 to EOT or ET were included in the analysis. Hb values within 4 weeks after an RBC transfusion was excluded.

7. Percentage of Participants Who Achieved a ≥2 g/dL Increase in Hb From Baseline Through Week 16 [Baseline through Week 16]

   The 95% CI was based on the exact method of Clopper-Pearson method. All central lab assessments from Day 1 to EOT or ET were included in the analysis. Hb values within 4 weeks after an RBC transfusion was excluded.

8. Percentage of Participants Who Had an RBC Transfusion From Beginning of Week 5 (Day 29) to Week 16 [Week 5 to Week 16]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Diagnosis of non-myeloid malignancy

2. Anemia caused by cancer treatment (myelosuppressive chemotherapy) defined as Hb ≤10.0 grams (g)/deciliter (dL) at screening

3. Planned concurrent treatment of cancer with chemotherapy for at least 8 additional weeks

4. Estimated life expectancy ≥ 6 months at enrollment (Day 1)

Exclusion Criteria:

1. Participants with cancer receiving chemotherapy when the anticipated outcome is cure

2. Participants who are only receiving hormonal products, biological products, cancer immunotherapy or radiation therapy to treat/manage their cancer

3. History of leukemia

4. Participants who have received an RBC transfusion or erythropoietic therapy within 4 weeks of enrollment

5. Use of any investigational drug within 8-weeks prior to treatment with roxadustat

6. Clinically significant anemia due to other etiologies

7. Cardiovascular risks, such as myocardial infarction, stroke, heart failure or thromboembolic event (for example, deep vein thrombosis [DVT] or pulmonary embolism) within previous 6 months of screening

8. Clinically significant or uncontrolled ongoing autoimmune disease (for example, rheumatoid arthritis, Crohn's disease, celiac disease, etc.)

9. Known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Center	Los Alamitos	California	United States	90720
2	Research Center	Los Angeles	California	United States	90024
3	Research Center	Torrance	California	United States	90505
4	Research Center	Jacksonville	Florida	United States	32256
5	Research Center	Plantation	Florida	United States	33322
6	Research Center	Fort Wayne	Indiana	United States	46804
7	Research Center	Ashland	Kentucky	United States	41101
8	Research Center	Covington	Louisiana	United States	70433
9	Research Center	Bethesda	Maryland	United States	20817
10	Research Center	Livingston	New Jersey	United States	07039
11	Research Center	Bronx	New York	United States	10469
12	Research Center	Port Jefferson Station	New York	United States	11776
13	Research Center	Canton	Ohio	United States	44718
14	Research Center	Gettysburg	Pennsylvania	United States	17325
15	Research Center	Philadelphia	Pennsylvania	United States	19106

Sponsors and Collaborators

• FibroGen
• AstraZeneca
• Astellas Pharma Inc

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - May 22, 2020
• Statistical Analysis Plan - Jul 14, 2021

More Information

Publications

None provided.

• Responsible Party: FibroGen
• ClinicalTrials.gov Identifier: NCT04076943
• Other Study ID Numbers: FGCL-4592-092
• First Posted: Sep 4, 2019
• Last Update Posted: Jun 3, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by FibroGen: Anemia; Chemotherapy induced anemia; Myelosuppressive chemotherapy; Non-Myeloid malignances
• Additional relevant MeSH terms: Anemia

Study Results

Participant Flow

Arm/Group Title	Roxadustat
Arm/Group Description	Participants received roxadustat as an oral tablet, 3 times per week (TIW) for up to a maximum of 16 weeks. The starting dose of roxadustat was 2.0 milligrams (mg)/kilogram (kg). The dose was updated with Amendment 3 (dated 22 May 2020) for newly enrolled participants by 1 level that is, from 2.0 mg/kg to 2.5 mg/kg level to achieve an improved hemoglobin (Hb) response.
Period Title: Overall Study
STARTED	92
Received at Least 1 Dose of Study Drug	92
COMPLETED	58
NOT COMPLETED	34

Baseline Characteristics

Arm/Group Title	Roxadustat
Arm/Group Description	Participants received roxadustat as an oral tablet, TIW for up to a maximum of 16 weeks. The starting dose of roxadustat was 2.0 mg/kg. The dose was updated with Amendment 3 (dated 22 May 2020) for newly enrolled participants by 1 level that is, from 2.0 mg/kg to 2.5 mg/kg level to achieve an improved Hb response.
Overall Participants	92
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.8 (10.44)
Sex: Female, Male (Count of Participants)
Female	53 57.6%
Male	39 42.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	7 7.6%
Not Hispanic or Latino	82 89.1%
Unknown or Not Reported	3 3.3%
Race/Ethnicity, Customized (Count of Participants)
White	76 82.6%
Black or African American	12 13%
Asian	3 3.3%
Other	1 1.1%
Baseline Hemoglobin (Hb) (grams (g)/deciliter (dL)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [grams (g)/deciliter (dL)]	8.59 (0.956)

Outcome Measures

1. Primary Outcome

Title	Maximum Change in Hb Within 16 Weeks From Baseline Without Red Blood Cell (RBC) Transfusion
Description	Baseline Hb was defined as the mean of the assessments from central lab prior to first dose of the study treatment, which included up to 2 latest screening values prior to Day 1 and a value on Day 1. All central lab assessments from Day 1 to end of treatment (EOT) or early termination (ET) were included in the evaluation of this endpoint. Hb values within 4 weeks after an RBC transfusion were excluded.
Time Frame	Baseline, up to Week 16

Outcome Measure Data

Analysis Population Description

Full analysis set included all enrolled participants who received at least 1 dose of roxadustat, had a baseline Hb and at least 1 central lab Hb assessment during the treatment period.

Arm/Group Title	Roxadustat
Arm/Group Description	Participants received roxadustat as an oral tablet, TIW for up to a maximum of 16 weeks. The starting dose of roxadustat was 2.0 mg/kg. The dose was updated with Amendment 3 (dated 22 May 2020) for newly enrolled participants by 1 level that is, from 2.0 mg/kg to 2.5 mg/kg level to achieve an improved Hb response.
Measure Participants	89
Mean (Standard Deviation) [g/dL]	2.47 (1.510)

2. Secondary Outcome

Title	Mean Change in Hb Level From Baseline to Week 16 (Without RBC Transfusion)
Description	Baseline Hb was defined as the mean of the assessments from central lab prior to first dose of the study treatment, which included up to 2 latest screening values prior to Day 1 and a value on Day 1. Mean Hb during treatment was computed using the mean area-under-the-curve trapezoid method, from Day 1 to EOT or ET Hb assessment.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

Full analysis set included all enrolled participants who received at least 1 dose of roxadustat, had a baseline Hb and at least 1 central lab Hb assessment during the treatment period.

Arm/Group Title	Roxadustat
Arm/Group Description	Participants received roxadustat as an oral tablet, TIW for up to a maximum of 16 weeks. The starting dose of roxadustat was 2.0 mg/kg. The dose was updated with Amendment 3 (dated 22 May 2020) for newly enrolled participants by 1 level that is, from 2.0 mg/kg to 2.5 mg/kg level to achieve an improved Hb response.
Measure Participants	89
Mean (Standard Deviation) [g/dL]	1.20 (1.012)

3. Secondary Outcome

Title	Change in Hb From Baseline at Weeks 9, 13, and 16 (Without RBC Transfusion)
Description	Baseline Hb was defined as the mean of the assessments from central lab prior to first dose of the study treatment, which included up to 2 latest screening values prior to Day 1 and a value on Day 1.
Time Frame	Baseline, Weeks 9, 13, and 16

Outcome Measure Data

Analysis Population Description

Full analysis set included all enrolled participants who received at least 1 dose of roxadustat, had a baseline Hb and at least 1 central lab Hb assessment during the treatment period. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.

Arm/Group Title	Roxadustat
Arm/Group Description	Participants received roxadustat as an oral tablet, TIW for up to a maximum of 16 weeks. The starting dose of roxadustat was 2.0 mg/kg. The dose was updated with Amendment 3 (dated 22 May 2020) for newly enrolled participants by 1 level that is, from 2.0 mg/kg to 2.5 mg/kg level to achieve an improved Hb response.
Measure Participants	61
Change at Week 9	1.43 (1.421)
Change at Week 13	2.15 (1.921)
Change at Week 16	2.52 (1.700)

4. Secondary Outcome

Title	Percentage of Participants Who Achieved a ≥1 g/dL Increase in Hb From Baseline Through Week 16
Description	The 95% confidence interval (CI) was based on the exact method of Clopper-Pearson method. All central lab assessments from Day 1 to EOT or ET were included in the analysis. Hb values within 4 weeks after an RBC transfusion was excluded.
Time Frame	Baseline through Week 16

Outcome Measure Data

Analysis Population Description

Full analysis set included all enrolled participants who received at least 1 dose of roxadustat, had a baseline Hb and at least 1 central lab Hb assessment during the treatment period.

Arm/Group Title	Roxadustat
Arm/Group Description	Participants received roxadustat as an oral tablet, TIW for up to a maximum of 16 weeks. The starting dose of roxadustat was 2.0 mg/kg. The dose was updated with Amendment 3 (dated 22 May 2020) for newly enrolled participants by 1 level that is, from 2.0 mg/kg to 2.5 mg/kg level to achieve an improved Hb response.
Measure Participants	89
Number (95% Confidence Interval) [percentage of participants]	82.0 89.1%

5. Secondary Outcome

Title	Time to Achieve a ≥1 g/dL Increase in Hb From Baseline Through Week 16
Description	Median was calculated using Kaplan-Meier product limit method. 95% CI was calculated using the method of Brookmeyer and Crowley. All central lab assessments from Day 1 to EOT or ET were included in the analysis. Hb values within 4 weeks after an RBC transfusion were excluded.
Time Frame	Baseline through Week 16

Outcome Measure Data

Analysis Population Description

Full analysis set included all enrolled participants who received at least 1 dose of roxadustat, had a baseline Hb and at least 1 central lab Hb assessment during the treatment period.

Arm/Group Title	Roxadustat
Arm/Group Description	Participants received roxadustat as an oral tablet, TIW for up to a maximum of 16 weeks. The starting dose of roxadustat was 2.0 mg/kg. The dose was updated with Amendment 3 (dated 22 May 2020) for newly enrolled participants by 1 level that is, from 2.0 mg/kg to 2.5 mg/kg level to achieve an improved Hb response.
Measure Participants	89
Median (95% Confidence Interval) [days]	41.0

6. Secondary Outcome

Title	Percentage of Participants Who Achieved a ≥1.5 g/dL Increase in Hb From Baseline Through Week 16
Description	The 95% CI was based on the exact method of Clopper-Pearson method. All central lab assessments from Day 1 to EOT or ET were included in the analysis. Hb values within 4 weeks after an RBC transfusion was excluded.
Time Frame	Baseline through Week 16

Outcome Measure Data

Analysis Population Description

Full analysis set included all enrolled participants who received at least 1 dose of roxadustat, had a baseline Hb and at least 1 central lab Hb assessment during the treatment period.

Arm/Group Title	Roxadustat
Arm/Group Description	Participants received roxadustat as an oral tablet, TIW for up to a maximum of 16 weeks. The starting dose of roxadustat was 2.0 mg/kg. The dose was updated with Amendment 3 (dated 22 May 2020) for newly enrolled participants by 1 level that is, from 2.0 mg/kg to 2.5 mg/kg level to achieve an improved Hb response.
Measure Participants	89
Number (95% Confidence Interval) [percentage of participants]	73.0 79.3%

7. Secondary Outcome

Title	Percentage of Participants Who Achieved a Hematopoietic Response
Description	Hematopoietic response was defined as an increase in Hb of 1.5 g/dL from baseline or attaining a Hb of 11 g/dL. The 95% CI was based on the exact method of Clopper-Pearson method. All central lab assessments from Day 1 to EOT or ET were included in the analysis. Hb values within 4 weeks after an RBC transfusion was excluded.
Time Frame	Baseline through Week 16

Outcome Measure Data

Analysis Population Description

Full analysis set included all enrolled participants who received at least 1 dose of roxadustat, had a baseline Hb and at least 1 central lab Hb assessment during the treatment period.

Arm/Group Title	Roxadustat
Arm/Group Description	Participants received roxadustat as an oral tablet, TIW for up to a maximum of 16 weeks. The starting dose of roxadustat was 2.0 mg/kg. The dose was updated with Amendment 3 (dated 22 May 2020) for newly enrolled participants by 1 level that is, from 2.0 mg/kg to 2.5 mg/kg level to achieve an improved Hb response.
Measure Participants	89
Number (95% Confidence Interval) [percentage of participants]	75.3 81.8%

8. Secondary Outcome

Title	Percentage of Participants Who Achieved a ≥2 g/dL Increase in Hb From Baseline Through Week 16
Description	The 95% CI was based on the exact method of Clopper-Pearson method. All central lab assessments from Day 1 to EOT or ET were included in the analysis. Hb values within 4 weeks after an RBC transfusion was excluded.
Time Frame	Baseline through Week 16

Outcome Measure Data

Analysis Population Description

Full analysis set included all enrolled participants who received at least 1 dose of roxadustat, had a baseline Hb and at least 1 central lab Hb assessment during the treatment period.

Arm/Group Title	Roxadustat
Arm/Group Description	Participants received roxadustat as an oral tablet, TIW for up to a maximum of 16 weeks. The starting dose of roxadustat was 2.0 mg/kg. The dose was updated with Amendment 3 (dated 22 May 2020) for newly enrolled participants by 1 level that is, from 2.0 mg/kg to 2.5 mg/kg level to achieve an improved Hb response.
Measure Participants	89
Number (95% Confidence Interval) [percentage of participants]	60.7 66%

9. Secondary Outcome

Title	Percentage of Participants Who Had an RBC Transfusion From Beginning of Week 5 (Day 29) to Week 16
Time Frame	Week 5 to Week 16

Outcome Measure Data

Analysis Population Description

Full analysis set included all enrolled participants who received at least 1 dose of roxadustat, had a baseline Hb and at least 1 central lab Hb assessment during the treatment period. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Arm/Group Title	Roxadustat
Arm/Group Description	Participants received roxadustat as an oral tablet, TIW for up to a maximum of 16 weeks. The starting dose of roxadustat was 2.0 mg/kg. The dose was updated with Amendment 3 (dated 22 May 2020) for newly enrolled participants by 1 level that is, from 2.0 mg/kg to 2.5 mg/kg level to achieve an improved Hb response.
Measure Participants	83
Number [percentage of participants]	14.5 15.8%

Adverse Events

Time Frame	Baseline up to Week 20
Adverse Event Reporting Description	Safety population included all participants who took at least 1 dose of study medication.
Arm/Group Title	Roxadustat
Arm/Group Description	Participants received roxadustat as an oral tablet, TIW for up to a maximum of 16 weeks. The starting dose of roxadustat was 2.0 mg/kg. The dose was updated with Amendment 3 (dated 22 May 2020) for newly enrolled participants by 1 level that is, from 2.0 mg/kg to 2.5 mg/kg level to achieve an improved Hb response.
All Cause Mortality
	Roxadustat
	Affected / at Risk (%)	# Events
Total	17/92 (18.5%)
Serious Adverse Events
	Roxadustat
	Affected / at Risk (%)	# Events
Total	40/92 (43.5%)
Blood and lymphatic system disorders
Febrile neutropenia	3/92 (3.3%)
Neutropenia	1/92 (1.1%)
Pancytopenia	1/92 (1.1%)
Anaemia	3/92 (3.3%)
Cardiac disorders
Acute myocardial infarction	2/92 (2.2%)
Atrial fibrillation	1/92 (1.1%)
Ventricular tachycardia	1/92 (1.1%)
Gastrointestinal disorders
Ascites	1/92 (1.1%)
Diarrhoea	2/92 (2.2%)
Gastrointestinal haemorrhage	1/92 (1.1%)
Nausea	1/92 (1.1%)
Odynophagia	1/92 (1.1%)
Pancreatitis	1/92 (1.1%)
Proctalgia	1/92 (1.1%)
Vomiting	2/92 (2.2%)
General disorders
Asthenia	3/92 (3.3%)
Chills	1/92 (1.1%)
Disease progression	3/92 (3.3%)
Infections and infestations
COVID-19 pneumonia	1/92 (1.1%)
Cellulitis	1/92 (1.1%)
Diverticulitis	1/92 (1.1%)
Pneumonia bacterial	1/92 (1.1%)
Retroperitoneal abscess	1/92 (1.1%)
Sepsis	3/92 (3.3%)
Staphylococcal infection	1/92 (1.1%)
Urinary tract infection	1/92 (1.1%)
Injury, poisoning and procedural complications
Delayed haemolytic transfusion reaction	1/92 (1.1%)
Rib fracture	1/92 (1.1%)
Metabolism and nutrition disorders
Dehydration	2/92 (2.2%)
Hyponatraemia	1/92 (1.1%)
Musculoskeletal and connective tissue disorders
Pathological fracture	1/92 (1.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer metastatic	1/92 (1.1%)
Cholangiocarcinoma	1/92 (1.1%)
Malignant pleural effusion	1/92 (1.1%)
Ovarian cancer	1/92 (1.1%)
Pancreatic carcinoma metastatic	4/92 (4.3%)
Rectal cancer	1/92 (1.1%)
Small cell lung cancer metastatic	1/92 (1.1%)
Thyroid cancer	1/92 (1.1%)
Nervous system disorders
Seizure	2/92 (2.2%)
Status epilepticus	1/92 (1.1%)
Syncope	1/92 (1.1%)
Psychiatric disorders
Mental status changes	3/92 (3.3%)
Renal and urinary disorders
Acute kidney injury	2/92 (2.2%)
Bladder pain	1/92 (1.1%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	1/92 (1.1%)
Anoxia	1/92 (1.1%)
Pneumonitis	1/92 (1.1%)
Pulmonary embolism	4/92 (4.3%)
Respiratory failure	2/92 (2.2%)
Vascular disorders
Deep vein thrombosis	3/92 (3.3%)
Hypotension	2/92 (2.2%)
Vena cava embolism	1/92 (1.1%)
Other (Not Including Serious) Adverse Events
	Roxadustat
	Affected / at Risk (%)	# Events
Total	71/92 (77.2%)
Blood and lymphatic system disorders
Neutropenia	10/92 (10.9%)
Thrombocytopenia	10/92 (10.9%)
Gastrointestinal disorders
Abdominal pain	6/92 (6.5%)
Constipation	10/92 (10.9%)
Diarrhoea	14/92 (15.2%)
Nausea	18/92 (19.6%)
Vomiting	12/92 (13%)
General disorders
Fatigue	23/92 (25%)
Oedema peripheral	9/92 (9.8%)
Pyrexia	6/92 (6.5%)
Injury, poisoning and procedural complications
Fall	5/92 (5.4%)
Metabolism and nutrition disorders
Decreased appetite	10/92 (10.9%)
Dehydration	6/92 (6.5%)
Hypokalaemia	6/92 (6.5%)
Musculoskeletal and connective tissue disorders
Arthralgia	5/92 (5.4%)
Muscular weakness	5/92 (5.4%)
Nervous system disorders
Dizziness	6/92 (6.5%)
Headache	5/92 (5.4%)
Respiratory, thoracic and mediastinal disorders
Cough	6/92 (6.5%)
Dyspnoea	16/92 (17.4%)
Pulmonary embolism	5/92 (5.4%)
Skin and subcutaneous tissue disorders
Rash	6/92 (6.5%)
Vascular disorders
Deep vein thrombosis	11/92 (12%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The multisite consortium can publish any time after the data is collected and analyzed by FibroGen. The investigator can only publish after the multisite consortium publishes (or tries to publish and fails). FibroGen has 60 days to review a publication and can extend the embargo up to an additional 120 days (or 180 total).