Trial Outcomes & Findings for Evaluation of Efficacy and Safety of Roxadustat for the Treatment of Chemotherapy Induced Anemia (NCT NCT04076943)
NCT ID: NCT04076943
Last Updated: 2022-06-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
92 participants
Primary outcome timeframe
Baseline, up to Week 16
Results posted on
2022-06-03
Participant Flow
Participant milestones
| Measure |
Roxadustat
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.
|
|---|---|
|
Overall Study
STARTED
|
92
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
92
|
|
Overall Study
COMPLETED
|
58
|
|
Overall Study
NOT COMPLETED
|
34
|
Reasons for withdrawal
| Measure |
Roxadustat
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.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
12
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Progressive Disease
|
2
|
|
Overall Study
Death
|
13
|
|
Overall Study
Other than specified
|
6
|
Baseline Characteristics
Evaluation of Efficacy and Safety of Roxadustat for the Treatment of Chemotherapy Induced Anemia
Baseline characteristics by cohort
| Measure |
Roxadustat
n=92 Participants
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.
|
|---|---|
|
Age, Continuous
|
66.8 years
STANDARD_DEVIATION 10.44 • n=99 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
82 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
76 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
12 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
|
Baseline Hemoglobin (Hb)
|
8.59 grams (g)/deciliter (dL)
STANDARD_DEVIATION 0.956 • n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline, up to Week 16Population: 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.
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.
Outcome measures
| Measure |
Roxadustat
n=89 Participants
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.
|
|---|---|
|
Maximum Change in Hb Within 16 Weeks From Baseline Without Red Blood Cell (RBC) Transfusion
|
2.47 g/dL
Standard Deviation 1.510
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: 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.
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.
Outcome measures
| Measure |
Roxadustat
n=89 Participants
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.
|
|---|---|
|
Mean Change in Hb Level From Baseline to Week 16 (Without RBC Transfusion)
|
1.20 g/dL
Standard Deviation 1.012
|
SECONDARY outcome
Timeframe: Baseline, Weeks 9, 13, and 16Population: 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.
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.
Outcome measures
| Measure |
Roxadustat
n=61 Participants
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.
|
|---|---|
|
Change in Hb From Baseline at Weeks 9, 13, and 16 (Without RBC Transfusion)
Change at Week 9
|
1.43 g/dL
Standard Deviation 1.421
|
|
Change in Hb From Baseline at Weeks 9, 13, and 16 (Without RBC Transfusion)
Change at Week 13
|
2.15 g/dL
Standard Deviation 1.921
|
|
Change in Hb From Baseline at Weeks 9, 13, and 16 (Without RBC Transfusion)
Change at Week 16
|
2.52 g/dL
Standard Deviation 1.700
|
SECONDARY outcome
Timeframe: Baseline through Week 16Population: 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.
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.
Outcome measures
| Measure |
Roxadustat
n=89 Participants
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.
|
|---|---|
|
Percentage of Participants Who Achieved a ≥1 g/dL Increase in Hb From Baseline Through Week 16
|
82.0 percentage of participants
Interval 72.5 to 89.4
|
SECONDARY outcome
Timeframe: Baseline through Week 16Population: 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.
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.
Outcome measures
| Measure |
Roxadustat
n=89 Participants
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.
|
|---|---|
|
Time to Achieve a ≥1 g/dL Increase in Hb From Baseline Through Week 16
|
41.0 days
Interval 29.0 to 46.0
|
SECONDARY outcome
Timeframe: Baseline through Week 16Population: 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.
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.
Outcome measures
| Measure |
Roxadustat
n=89 Participants
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.
|
|---|---|
|
Percentage of Participants Who Achieved a ≥1.5 g/dL Increase in Hb From Baseline Through Week 16
|
73.0 percentage of participants
Interval 62.6 to 81.9
|
SECONDARY outcome
Timeframe: Baseline through Week 16Population: 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.
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.
Outcome measures
| Measure |
Roxadustat
n=89 Participants
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.
|
|---|---|
|
Percentage of Participants Who Achieved a Hematopoietic Response
|
75.3 percentage of participants
Interval 65.0 to 83.8
|
SECONDARY outcome
Timeframe: Baseline through Week 16Population: 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.
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.
Outcome measures
| Measure |
Roxadustat
n=89 Participants
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.
|
|---|---|
|
Percentage of Participants Who Achieved a ≥2 g/dL Increase in Hb From Baseline Through Week 16
|
60.7 percentage of participants
Interval 49.7 to 70.9
|
SECONDARY outcome
Timeframe: Week 5 to Week 16Population: 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.
Outcome measures
| Measure |
Roxadustat
n=83 Participants
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.
|
|---|---|
|
Percentage of Participants Who Had an RBC Transfusion From Beginning of Week 5 (Day 29) to Week 16
|
14.5 percentage of participants
|
Adverse Events
Roxadustat
Serious events: 40 serious events
Other events: 71 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
Roxadustat
n=92 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.3%
3/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.1%
1/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.1%
1/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Cardiac disorders
Acute myocardial infarction
|
2.2%
2/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Cardiac disorders
Atrial fibrillation
|
1.1%
1/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Cardiac disorders
Ventricular tachycardia
|
1.1%
1/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Ascites
|
1.1%
1/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
2/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.1%
1/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
1.1%
1/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Odynophagia
|
1.1%
1/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.1%
1/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Proctalgia
|
1.1%
1/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
2/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
General disorders
Asthenia
|
3.3%
3/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
General disorders
Chills
|
1.1%
1/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
General disorders
Disease progression
|
3.3%
3/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Infections and infestations
COVID-19 pneumonia
|
1.1%
1/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Infections and infestations
Cellulitis
|
1.1%
1/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Infections and infestations
Diverticulitis
|
1.1%
1/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia bacterial
|
1.1%
1/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Infections and infestations
Retroperitoneal abscess
|
1.1%
1/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Infections and infestations
Sepsis
|
3.3%
3/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Infections and infestations
Staphylococcal infection
|
1.1%
1/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
1.1%
1/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Delayed haemolytic transfusion reaction
|
1.1%
1/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
1.1%
1/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.2%
2/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.1%
1/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
1.1%
1/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer metastatic
|
1.1%
1/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
1.1%
1/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
1.1%
1/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
1.1%
1/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
4.3%
4/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
1.1%
1/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
1.1%
1/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
1.1%
1/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Nervous system disorders
Seizure
|
2.2%
2/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Nervous system disorders
Status epilepticus
|
1.1%
1/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Nervous system disorders
Syncope
|
1.1%
1/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Psychiatric disorders
Mental status changes
|
3.3%
3/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.2%
2/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Renal and urinary disorders
Bladder pain
|
1.1%
1/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.1%
1/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Anoxia
|
1.1%
1/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.1%
1/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.3%
4/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.2%
2/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Vascular disorders
Deep vein thrombosis
|
3.3%
3/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Vascular disorders
Hypotension
|
2.2%
2/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Vascular disorders
Vena cava embolism
|
1.1%
1/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.3%
3/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
Other adverse events
| Measure |
Roxadustat
n=92 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
10.9%
10/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.9%
10/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.5%
6/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
10.9%
10/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.2%
14/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
19.6%
18/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
13.0%
12/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
General disorders
Fatigue
|
25.0%
23/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
General disorders
Oedema peripheral
|
9.8%
9/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
General disorders
Pyrexia
|
6.5%
6/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
5.4%
5/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.9%
10/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.5%
6/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.5%
6/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.4%
5/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.4%
5/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Nervous system disorders
Dizziness
|
6.5%
6/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
5.4%
5/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.5%
6/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.4%
16/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.4%
5/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.5%
6/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
|
Vascular disorders
Deep vein thrombosis
|
12.0%
11/92 • Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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).
- Publication restrictions are in place
Restriction type: OTHER