Trial Outcomes & Findings for Early Initiation of Oral Therapy With Cyclosporine and Eltrombopag for Treatment Naive Severe Aplastic Anemia (SAA) (NCT NCT04304820)
NCT ID: NCT04304820
Last Updated: 2026-01-09
Results Overview
For the primary endpoint of this study, the treatment is defined to be "feasible" to a participant if he/she meets the safety and feasibility criteria. Safety and feasibility criteria is a composite measure of as defined as TRSAE, mis- and altered diagnosis, and non-compliance with the regimen or failure to establish care at the National Institutes of Health Clinical Center. Study treatment period is defined as the duration from the initiation of oral treatment (low dose Cyclosporine and Eltrombopag) to the start of standard of care treatment (horse anti-thymocyte-globulin).
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
Up to 12 Weeks from the initiation of oral treatment (Low Dose Cyclosporine and Eltrombopag)
Results posted on
2026-01-09
Participant Flow
Participant milestones
| Measure |
Participants With Severe Aplastic Anemia in Early Initiation of Cyclosporine and Eltrombopag
Treatment-naïve Severe Aplastic Anemia (SAA) participants start Cyclosporine (CsA) on Day 1 at 2 mg/kg/day. At initiation of Horse Anti-Thymocyte-Globulin (h-ATG), dosing increases to 3 mg/kg every 12 hours for those ≥12 years (6 mg/kg/day total) and 6 mg/kg every 12 hours for those \<12 years (12 mg/kg/day total). Actual body weight is used unless \>125% ideal body weight (IBW), where adjusted IBW applies. CsA is titrated to a trough of 200-400 mcg/L. At 6 months, responders reduce to 2 mg/kg/day through 24 months, with return to full dosing if relapse occurs. h-ATG is given at 40 mg/kg/day for 4 days IV, unless the patient already shows a complete response at the initial NIH visit after remote oral therapy.
Eltrombopag (EPAG) starts on Day at 150 mg/day for ages 12-17, 75 mg/day for ages 6-11, and 2.5 mg/kg/day for ages 3-5. For East and Southeast Asian patients, starting doses are reduced to 75 mg/day (ages 12-85), 37.5 mg/day (ages 6-11), and 1.25 mg/kg/day (ages 3-5).
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Participants With Severe Aplastic Anemia in Early Initiation of Cyclosporine and Eltrombopag
Treatment-naïve Severe Aplastic Anemia (SAA) participants start Cyclosporine (CsA) on Day 1 at 2 mg/kg/day. At initiation of Horse Anti-Thymocyte-Globulin (h-ATG), dosing increases to 3 mg/kg every 12 hours for those ≥12 years (6 mg/kg/day total) and 6 mg/kg every 12 hours for those \<12 years (12 mg/kg/day total). Actual body weight is used unless \>125% ideal body weight (IBW), where adjusted IBW applies. CsA is titrated to a trough of 200-400 mcg/L. At 6 months, responders reduce to 2 mg/kg/day through 24 months, with return to full dosing if relapse occurs. h-ATG is given at 40 mg/kg/day for 4 days IV, unless the patient already shows a complete response at the initial NIH visit after remote oral therapy.
Eltrombopag (EPAG) starts on Day at 150 mg/day for ages 12-17, 75 mg/day for ages 6-11, and 2.5 mg/kg/day for ages 3-5. For East and Southeast Asian patients, starting doses are reduced to 75 mg/day (ages 12-85), 37.5 mg/day (ages 6-11), and 1.25 mg/kg/day (ages 3-5).
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Pursuing Stem Cell Transplant
|
4
|
|
Overall Study
Pursuing Additional Immunosuppressive therapy
|
4
|
|
Overall Study
Evolution to Myeloid Malignancy
|
1
|
Baseline Characteristics
Early Initiation of Oral Therapy With Cyclosporine and Eltrombopag for Treatment Naive Severe Aplastic Anemia (SAA)
Baseline characteristics by cohort
| Measure |
Participants With Severe Aplastic Anemia in Early Initiation of Cyclosporine and Eltrombopag
n=39 Participants
Treatment-naïve Severe Aplastic Anemia (SAA) participants start Cyclosporine (CsA) on Day 1 at 2 mg/kg/day. At initiation of Horse Anti-Thymocyte-Globulin (h-ATG), dosing increases to 3 mg/kg every 12 hours for those ≥12 years (6 mg/kg/day total) and 6 mg/kg every 12 hours for those \<12 years (12 mg/kg/day total). Actual body weight is used unless \>125% ideal body weight (IBW), where adjusted IBW applies. CsA is titrated to a trough of 200-400 mcg/L. At 6 months, responders reduce to 2 mg/kg/day through 24 months, with return to full dosing if relapse occurs. h-ATG is given at 40 mg/kg/day for 4 days IV, unless the patient already shows a complete response at the initial NIH visit after remote oral therapy.
Eltrombopag (EPAG) starts on Day at 150 mg/day for ages 12-17, 75 mg/day for ages 6-11, and 2.5 mg/kg/day for ages 3-5. For East and Southeast Asian patients, starting doses are reduced to 75 mg/day (ages 12-85), 37.5 mg/day (ages 6-11), and 1.25 mg/kg/day (ages 3-5).
|
|---|---|
|
Age, Categorical
<=18 years
|
5 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Up to 12 Weeks from the initiation of oral treatment (Low Dose Cyclosporine and Eltrombopag)Population: analysis was intention-to-treat
For the primary endpoint of this study, the treatment is defined to be "feasible" to a participant if he/she meets the safety and feasibility criteria. Safety and feasibility criteria is a composite measure of as defined as TRSAE, mis- and altered diagnosis, and non-compliance with the regimen or failure to establish care at the National Institutes of Health Clinical Center. Study treatment period is defined as the duration from the initiation of oral treatment (low dose Cyclosporine and Eltrombopag) to the start of standard of care treatment (horse anti-thymocyte-globulin).
Outcome measures
| Measure |
Participants With Severe Aplastic Anemia in Early Initiation of Cyclosporine and Eltrombopag
n=39 Participants
Treatment-naïve Severe Aplastic Anemia (SAA) participants start Cyclosporine (CsA) on Day 1 at 2 mg/kg/day. At initiation of Horse Anti-Thymocyte-Globulin (h-ATG), dosing increases to 3 mg/kg every 12 hours for those ≥12 years (6 mg/kg/day total) and 6 mg/kg every 12 hours for those \<12 years (12 mg/kg/day total). Actual body weight is used unless \>125% ideal body weight (IBW), where adjusted IBW applies. CsA is titrated to a trough of 200-400 mcg/L. At 6 months, responders reduce to 2 mg/kg/day through 24 months, with return to full dosing if relapse occurs. h-ATG is given at 40 mg/kg/day for 4 days IV, unless the patient already shows a complete response at the initial NIH visit after remote oral therapy.
Eltrombopag (EPAG) starts on Day at 150 mg/day for ages 12-17, 75 mg/day for ages 6-11, and 2.5 mg/kg/day for ages 3-5. For East and Southeast Asian patients, starting doses are reduced to 75 mg/day (ages 12-85), 37.5 mg/day (ages 6-11), and 1.25 mg/kg/day (ages 3-5).
|
|---|---|
|
Number of Participants Meeting Safety and Feasibility Criteria During Study Treatment Period With Oral Treatment (Low Dose Cyclosporine and Eltrombopag) Until the Start of Standard of Care Treatment (Horse Anti-thymocyte-globulin)
|
37 Participants
|
SECONDARY outcome
Timeframe: At 1, 2, 3, 6 and 12 months and yearly thereafterOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 1, 2, 3, 6 and 12 months and yearly thereafterOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 1, 2, 3, 6 and 12 months and yearly thereafterOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 5 Years (60 Months)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 1, 2, 3, 6 and 12 months and yearly thereafterOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 1, 2, 3, 6 and 12 months and yearly thereafterOutcome measures
Outcome data not reported
Adverse Events
Participants With Severe Aplastic Anemia in Early Initiation of Cyclosporine and Eltrombopag
Serious events: 24 serious events
Other events: 39 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Participants With Severe Aplastic Anemia in Early Initiation of Cyclosporine and Eltrombopag
n=39 participants at risk
Treatment-naïve Severe Aplastic Anemia (SAA) participants start Cyclosporine (CsA) on Day 1 at 2 mg/kg/day. At initiation of Horse Anti-Thymocyte-Globulin (h-ATG), dosing increases to 3 mg/kg every 12 hours for those ≥12 years (6 mg/kg/day total) and 6 mg/kg every 12 hours for those \<12 years (12 mg/kg/day total). Actual body weight is used unless \>125% ideal body weight (IBW), where adjusted IBW applies. CsA is titrated to a trough of 200-400 mcg/L. At 6 months, responders reduce to 2 mg/kg/day through 24 months, with return to full dosing if relapse occurs. h-ATG is given at 40 mg/kg/day for 4 days IV, unless the patient already shows a complete response at the initial NIH visit after remote oral therapy.
Eltrombopag (EPAG) starts on Day at 150 mg/day for ages 12-17, 75 mg/day for ages 6-11, and 2.5 mg/kg/day for ages 3-5. For East and Southeast Asian patients, starting doses are reduced to 75 mg/day (ages 12-85), 37.5 mg/day (ages 6-11), and 1.25 mg/kg/day (ages 3-5).
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.7%
3/39 • Number of events 4 • Up to 12 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Cardiac disorders
Paroxysmal atrial tachycardia
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Cardiac disorders
Sinus bradycardia
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Gastrointestinal disorders
Colitis
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Gastrointestinal disorders
Colonic perforation
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Gastrointestinal disorders
Enterocolitis
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Gastrointestinal disorders
Ileal obstruction
|
2.6%
1/39 • Number of events 2 • Up to 12 weeks
|
|
Gastrointestinal disorders
Mucositis oral
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Gastrointestinal disorders
Pancreatitis
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Gastrointestinal disorders
reversal of ileostomy
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Gastrointestinal disorders
Typhlitis
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Gastrointestinal disorders
Vomiting
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
General disorders
Chills
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
General disorders
Fever
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
General disorders
Multi-organ failure
|
2.6%
1/39 • Number of events 2 • Up to 12 weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Immune system disorders
Serum sickness
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Infections and infestations
Abdominal infection
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Infections and infestations
Anorectal infection
|
2.6%
1/39 • Number of events 3 • Up to 12 weeks
|
|
Infections and infestations
Bone infection
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Infections and infestations
Catheter related infection
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Infections and infestations
Covid-19 infection
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Infections and infestations
Enterocolitis
|
7.7%
3/39 • Number of events 3 • Up to 12 weeks
|
|
Infections and infestations
Pharyngitis
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Infections and infestations
Sepsis
|
7.7%
3/39 • Number of events 4 • Up to 12 weeks
|
|
Infections and infestations
Skin infection
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Infections and infestations
Upper respiratory infection
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Infections and infestations
Urinary tract infection
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Nervous system disorders
Dizziness
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Nervous system disorders
Increased Intracranial Pressure
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Nervous system disorders
Intracranial hemorrhage
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Psychiatric disorders
Mania
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Psychiatric disorders
Suicidal ideation
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Renal and urinary disorders
Hematuria
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Vascular disorders
Hematoma
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Vascular disorders
Thromboembolic event
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
Other adverse events
| Measure |
Participants With Severe Aplastic Anemia in Early Initiation of Cyclosporine and Eltrombopag
n=39 participants at risk
Treatment-naïve Severe Aplastic Anemia (SAA) participants start Cyclosporine (CsA) on Day 1 at 2 mg/kg/day. At initiation of Horse Anti-Thymocyte-Globulin (h-ATG), dosing increases to 3 mg/kg every 12 hours for those ≥12 years (6 mg/kg/day total) and 6 mg/kg every 12 hours for those \<12 years (12 mg/kg/day total). Actual body weight is used unless \>125% ideal body weight (IBW), where adjusted IBW applies. CsA is titrated to a trough of 200-400 mcg/L. At 6 months, responders reduce to 2 mg/kg/day through 24 months, with return to full dosing if relapse occurs. h-ATG is given at 40 mg/kg/day for 4 days IV, unless the patient already shows a complete response at the initial NIH visit after remote oral therapy.
Eltrombopag (EPAG) starts on Day at 150 mg/day for ages 12-17, 75 mg/day for ages 6-11, and 2.5 mg/kg/day for ages 3-5. For East and Southeast Asian patients, starting doses are reduced to 75 mg/day (ages 12-85), 37.5 mg/day (ages 6-11), and 1.25 mg/kg/day (ages 3-5).
|
|---|---|
|
Eye disorders
Subconjunctival Hemorrhage
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Eye disorders
Yellow Eyes
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
28.2%
11/39 • Number of events 13 • Up to 12 weeks
|
|
Gastrointestinal disorders
Acid Reflux
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Gastrointestinal disorders
Anal fissure
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Gastrointestinal disorders
Anal hemorrhage
|
7.7%
3/39 • Number of events 3 • Up to 12 weeks
|
|
Gastrointestinal disorders
Anal pain
|
2.6%
1/39 • Number of events 2 • Up to 12 weeks
|
|
Gastrointestinal disorders
Bleeding gums
|
20.5%
8/39 • Number of events 13 • Up to 12 weeks
|
|
Gastrointestinal disorders
Bleeding Lips
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Gastrointestinal disorders
Bloating
|
10.3%
4/39 • Number of events 4 • Up to 12 weeks
|
|
Gastrointestinal disorders
Constipation
|
25.6%
10/39 • Number of events 11 • Up to 12 weeks
|
|
Gastrointestinal disorders
Dental caries
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
35.9%
14/39 • Number of events 17 • Up to 12 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
17.9%
7/39 • Number of events 7 • Up to 12 weeks
|
|
Gastrointestinal disorders
Emesis
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Gastrointestinal disorders
Flatulence
|
7.7%
3/39 • Number of events 3 • Up to 12 weeks
|
|
Gastrointestinal disorders
Gastritis
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
12.8%
5/39 • Number of events 6 • Up to 12 weeks
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Gastrointestinal disorders
Gum inflammation
|
12.8%
5/39 • Number of events 5 • Up to 12 weeks
|
|
Gastrointestinal disorders
Gum Swelling
|
10.3%
4/39 • Number of events 4 • Up to 12 weeks
|
|
Gastrointestinal disorders
Gum tenderness
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Gastrointestinal disorders
Indigestion
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Gastrointestinal disorders
Lip Lesion
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Gastrointestinal disorders
Loose tooth
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Gastrointestinal disorders
Mucositis oral
|
5.1%
2/39 • Number of events 3 • Up to 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
38.5%
15/39 • Number of events 23 • Up to 12 weeks
|
|
Gastrointestinal disorders
Oral Blisters
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Gastrointestinal disorders
Oral hemorrhage
|
7.7%
3/39 • Number of events 3 • Up to 12 weeks
|
|
Gastrointestinal disorders
Oral pain
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Gastrointestinal disorders
oropharyngeal bleeding
|
2.6%
1/39 • Number of events 2 • Up to 12 weeks
|
|
Gastrointestinal disorders
Palate hypertrophy
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Gastrointestinal disorders
Paracolic fluid
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Gastrointestinal disorders
Periodontal disease
|
10.3%
4/39 • Number of events 4 • Up to 12 weeks
|
|
Gastrointestinal disorders
Rectal pain
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Gastrointestinal disorders
Rectal wall thickening
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Gastrointestinal disorders
Stomach pain
|
12.8%
5/39 • Number of events 5 • Up to 12 weeks
|
|
Gastrointestinal disorders
Stomatitis (inflamed and sore mouth)
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Gastrointestinal disorders
Swollen gingival
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Gastrointestinal disorders
Toothache
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
13/39 • Number of events 17 • Up to 12 weeks
|
|
General disorders
Ankle edema
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
General disorders
Aphthous ulcer
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
General disorders
Chills
|
48.7%
19/39 • Number of events 20 • Up to 12 weeks
|
|
General disorders
Edema face
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
General disorders
Edema limbs
|
30.8%
12/39 • Number of events 13 • Up to 12 weeks
|
|
General disorders
Facial pain
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
General disorders
Fatigue
|
23.1%
9/39 • Number of events 9 • Up to 12 weeks
|
|
General disorders
Fever
|
46.2%
18/39 • Number of events 20 • Up to 12 weeks
|
|
General disorders
Flu like symptoms
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
General disorders
generalized achiness
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
General disorders
Generalized edema
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
General disorders
Infusion site extravasation
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
General disorders
Injection site reaction
|
12.8%
5/39 • Number of events 5 • Up to 12 weeks
|
|
General disorders
Knee Pain
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
General disorders
Localized edema
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
General disorders
Malaise
|
7.7%
3/39 • Number of events 3 • Up to 12 weeks
|
|
General disorders
Non-cardiac chest pain
|
15.4%
6/39 • Number of events 6 • Up to 12 weeks
|
|
General disorders
Oedema
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
General disorders
Pain
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
General disorders
Side Pain
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
General disorders
Thigh pain
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Hepatobiliary disorders
Yellow Eyes
|
10.3%
4/39 • Number of events 5 • Up to 12 weeks
|
|
Immune system disorders
Hives
|
2.6%
1/39 • Number of events 2 • Up to 12 weeks
|
|
Immune system disorders
petechial rash
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Infections and infestations
Abdominal infection
|
2.6%
1/39 • Number of events 2 • Up to 12 weeks
|
|
Infections and infestations
Anorectal infection
|
2.6%
1/39 • Number of events 2 • Up to 12 weeks
|
|
Infections and infestations
Covid-19 infection
|
10.3%
4/39 • Number of events 4 • Up to 12 weeks
|
|
Infections and infestations
Folliculitis
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Infections and infestations
Herpes simplex reactivation
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Infections and infestations
Herpes simplex virus
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Infections and infestations
Human papillomavirus
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Infections and infestations
Klebsiella pneumoniae positive
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Infections and infestations
Lung infection
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Infections and infestations
Otitis externa
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Infections and infestations
Sepsis
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Infections and infestations
Sinusitis
|
10.3%
4/39 • Number of events 4 • Up to 12 weeks
|
|
Infections and infestations
Skin infection
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Infections and infestations
Stoma site infection
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Infections and infestations
Tick Bite
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Infections and infestations
Upper respiratory infection
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Infections and infestations
Urinary tract infection
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Injury, poisoning and procedural complications
Ankle Injury
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Injury, poisoning and procedural complications
Bleeding from Skin Biopsy site
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Injury, poisoning and procedural complications
Bruising
|
10.3%
4/39 • Number of events 4 • Up to 12 weeks
|
|
Injury, poisoning and procedural complications
Burn
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Injury, poisoning and procedural complications
Glass Splinter
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Injury, poisoning and procedural complications
Head Injury
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
7.7%
3/39 • Number of events 4 • Up to 12 weeks
|
|
Injury, poisoning and procedural complications
Petechiae
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Investigations
Activated partial thromboplastin time prolonged
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Investigations
Alanine aminotransferase increased
|
56.4%
22/39 • Number of events 43 • Up to 12 weeks
|
|
Investigations
Alkaline phosphatase increased
|
15.4%
6/39 • Number of events 6 • Up to 12 weeks
|
|
Investigations
Anemia
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
46.2%
18/39 • Number of events 28 • Up to 12 weeks
|
|
Investigations
Bilirubin, Direct increased
|
53.8%
21/39 • Number of events 26 • Up to 12 weeks
|
|
Investigations
Blood bicarbonate decreased
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Investigations
Blood bilirubin increased
|
71.8%
28/39 • Number of events 44 • Up to 12 weeks
|
|
Investigations
Blood lactate dehydrogenase increased
|
76.9%
30/39 • Number of events 39 • Up to 12 weeks
|
|
Investigations
C-reactive protein increase
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Investigations
Creatine Kinase increased
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Investigations
Creatinine increased
|
2.6%
1/39 • Number of events 24 • Up to 12 weeks
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Investigations
Haptoglobin decreased
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Investigations
Hypokalemia
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Investigations
Lymphocyte count decreased
|
7.7%
3/39 • Number of events 3 • Up to 12 weeks
|
|
Investigations
Neutrophil count decreased
|
30.8%
12/39 • Number of events 12 • Up to 12 weeks
|
|
Investigations
Platelet count decreased
|
28.2%
11/39 • Number of events 12 • Up to 12 weeks
|
|
Investigations
prothrombin time Increased
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Investigations
Weight gain
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Investigations
Weight loss
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Investigations
White blood cell decreased
|
51.3%
20/39 • Number of events 33 • Up to 12 weeks
|
|
Metabolism and nutrition disorders
Acidosis
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
12.8%
5/39 • Number of events 5 • Up to 12 weeks
|
|
Metabolism and nutrition disorders
Blood urea nitrogen increase
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Metabolism and nutrition disorders
Chloride increased
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Metabolism and nutrition disorders
Hyperchloremia
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
35.9%
14/39 • Number of events 18 • Up to 12 weeks
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
12.8%
5/39 • Number of events 6 • Up to 12 weeks
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
17.9%
7/39 • Number of events 7 • Up to 12 weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.6%
10/39 • Number of events 12 • Up to 12 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
64.1%
25/39 • Number of events 38 • Up to 12 weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.6%
10/39 • Number of events 13 • Up to 12 weeks
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Metabolism and nutrition disorders
Iron overload
|
38.5%
15/39 • Number of events 15 • Up to 12 weeks
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Metabolism and nutrition disorders
Phosphorus decreased
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Ankle pain (right)
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.1%
2/39 • Number of events 3 • Up to 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Elbow Pain (right)
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Growth suppression
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Jaw Pain
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Knee Pain
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
7.7%
3/39 • Number of events 3 • Up to 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
7.7%
3/39 • Number of events 3 • Up to 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.1%
2/39 • Number of events 3 • Up to 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
17.9%
7/39 • Number of events 7 • Up to 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Renal cyst
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Nervous system disorders
Arachnoid cyst
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Nervous system disorders
Dementia
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Nervous system disorders
Dizziness
|
15.4%
6/39 • Number of events 7 • Up to 12 weeks
|
|
Nervous system disorders
Extrapyramidal disorder
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Nervous system disorders
Headache
|
30.8%
12/39 • Number of events 20 • Up to 12 weeks
|
|
Nervous system disorders
Lethargy
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Nervous system disorders
Neuropathy
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Nervous system disorders
Paresthesia
|
20.5%
8/39 • Number of events 8 • Up to 12 weeks
|
|
Nervous system disorders
Seizure
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Nervous system disorders
Tremor
|
10.3%
4/39 • Number of events 4 • Up to 12 weeks
|
|
Psychiatric disorders
Agitation
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Psychiatric disorders
Anxiety
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Psychiatric disorders
Confusion
|
2.6%
1/39 • Number of events 2 • Up to 12 weeks
|
|
Psychiatric disorders
Flat Affect
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Psychiatric disorders
Hallucinations
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Psychiatric disorders
Insomnia
|
15.4%
6/39 • Number of events 6 • Up to 12 weeks
|
|
Psychiatric disorders
Jittery
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Psychiatric disorders
Restlessness
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Psychiatric disorders
sexual dysfunction
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Renal and urinary disorders
Dysuria
|
7.7%
3/39 • Number of events 4 • Up to 12 weeks
|
|
Renal and urinary disorders
Hematuria
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Renal and urinary disorders
Proteinuria
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Renal and urinary disorders
Suprapubic pain
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Renal and urinary disorders
Urinary incontinence
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Renal and urinary disorders
Urinary retention
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Renal and urinary disorders
Urine discoloration
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Renal and urinary disorders
Voiding Dysfunction
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Reproductive system and breast disorders
Acute Prostatitis
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Reproductive system and breast disorders
Epididymitis (testicle pain)
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Reproductive system and breast disorders
Hematochezia
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Reproductive system and breast disorders
Irregular menstruation
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Reproductive system and breast disorders
Menorrhagia
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.6%
1/39 • Number of events 2 • Up to 12 weeks
|
|
Reproductive system and breast disorders
Perineal pain
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Reproductive system and breast disorders
Prostate Calcification
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
3/39 • Number of events 3 • Up to 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.5%
8/39 • Number of events 9 • Up to 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.5%
8/39 • Number of events 13 • Up to 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypertension
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.1%
2/39 • Number of events 4 • Up to 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Jaw Pain
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinovirus
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
10.3%
4/39 • Number of events 4 • Up to 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Subglottic Edema
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper Airway Obstruction
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Skin and subcutaneous tissue disorders
Ashen Pallor
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Skin and subcutaneous tissue disorders
bilateral hyperpigmented lesions (oral)
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
23.1%
9/39 • Number of events 9 • Up to 12 weeks
|
|
Skin and subcutaneous tissue disorders
Hives
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
7.7%
3/39 • Number of events 3 • Up to 12 weeks
|
|
Skin and subcutaneous tissue disorders
Icterus
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Skin and subcutaneous tissue disorders
Keratotic growth
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritic rash
|
5.1%
2/39 • Number of events 3 • Up to 12 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
3/39 • Number of events 3 • Up to 12 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
15.4%
6/39 • Number of events 6 • Up to 12 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Skin and subcutaneous tissue disorders
Seborrheic keratosis
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Skin and subcutaneous tissue disorders
Shoulder Nodule (left)
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
28.2%
11/39 • Number of events 11 • Up to 12 weeks
|
|
Skin and subcutaneous tissue disorders
Yellow Skin
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Vascular disorders
Hot flashes
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Vascular disorders
Hypertension
|
51.3%
20/39 • Number of events 21 • Up to 12 weeks
|
|
Vascular disorders
Hypotension
|
23.1%
9/39 • Number of events 10 • Up to 12 weeks
|
|
Vascular disorders
Sinus tachycardia
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Vascular disorders
Superficial thrombophlebitis
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
12.8%
5/39 • Number of events 6 • Up to 12 weeks
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
13/39 • Number of events 17 • Up to 12 weeks
|
|
Cardiac disorders
Chest pain - cardiac
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Cardiac disorders
Chest pressure (right)
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Cardiac disorders
Chest Tighness
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Cardiac disorders
Hypotension
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Cardiac disorders
Non-cardiac chest pain
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Cardiac disorders
Palpitations
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Cardiac disorders
Paroxysmal atrial tachycardia
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Cardiac disorders
Right ventricular dysfunction
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Cardiac disorders
Sinus bradycardia
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Cardiac disorders
Sinus tachycardia
|
28.2%
11/39 • Number of events 16 • Up to 12 weeks
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Ear and labyrinth disorders
Ear pain
|
5.1%
2/39 • Number of events 3 • Up to 12 weeks
|
|
Ear and labyrinth disorders
Ear pressure
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Ear and labyrinth disorders
Tinnitus
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Endocrine disorders
Cushingoid
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Endocrine disorders
Thyroid nodule
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Eye disorders
Anemic Retinopathy
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Eye disorders
Blurred vision
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Eye disorders
Conjunctival Hemorrhage
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Eye disorders
Diplopia
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Eye disorders
Dry eye
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Eye disorders
Eye Drainage
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Eye disorders
Eye pain
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Eye disorders
Eye redness
|
7.7%
3/39 • Number of events 3 • Up to 12 weeks
|
|
Eye disorders
Flashing lights
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Eye disorders
Floaters
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Eye disorders
Inflamed Conjunctiva
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Eye disorders
Papilledema
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Eye disorders
Periorbital edema
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Eye disorders
Pinkish Conjunctiva
|
5.1%
2/39 • Number of events 2 • Up to 12 weeks
|
|
Eye disorders
Scleral Icterus
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
|
Eye disorders
Strabismus
|
2.6%
1/39 • Number of events 1 • Up to 12 weeks
|
Additional Information
Bhavisha Patel, M.D.
National Heart, Lung and Blood Institute (NHLBI)
Phone: 301-402-3477
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place