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This website is intended for US Healthcare Professionals.
Request a RepINDICATIONS
REBLOZYL® (luspatercept-aamt) is indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.
REBLOZYL® (luspatercept-aamt) is indicated for the treatment of anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions.
REBLOZYL® (luspatercept-aamt) is indicated for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell (RBC) units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).
REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.
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PATIENT OUTCOMES: REBLOZYL SAFETY
REBLOZYL offers a demonstrated safety profile1
The majority of adverse reactions with REBLOZYL were Grade 1 or 2 (mild to moderate)
- Serious adverse reactions occurred in 3.6% of patients on REBLOZYL
- Serious adverse reactions reported in 1% of patients were cerebrovascular accident and deep vein thrombosis
- A fatal adverse reaction occurred in 1 patient treated with REBLOZYL who died due to an unconfirmed case of acute myeloid leukemia (AML)
- Serious adverse reactions occurred in 3.6% of patients on REBLOZYL
- Serious adverse reactions reported in 1% of patients were cerebrovascular accident and deep vein thrombosis
- A fatal adverse reaction occurred in 1 patient treated with REBLOZYL who died due to an unconfirmed case of acute myeloid leukemia (AML)
Adverse reactions (>5%) in patients with beta-thalassemia receiving REBLOZYL with a difference between arms of 1% in the BELIEVE trial1
| Body system/Adverse reaction | REBLOZYL (n=223) |
Placebo (n=109) |
||
|---|---|---|---|---|
| All Grades n (%) |
Grade 3a n (%) |
All Grades n (%) |
Grade ≥3 n (%) |
|
| Musculoskeletal and connective tissue disorders | ||||
| Bone pain | 44 (20) | 3 (1) | 9 (8) | 0 (0) |
| Arthralgia | 43 (19) | 0 (0) | 13 (12) | 0 (0) |
| Infections and infestations | ||||
| Influenza | 19 (9) | 0 (0) | 6 (6) | 0 (0) |
| Viral upper respiratory infection | 14 (6) | 1 (0.4) | 2 (2) | 0 (0) |
| Nervous system disorders | ||||
| Headache | 58 (26) | 1 (<1) | 26 (24) | 1 (1) |
| Dizziness | 25 (11) | 0 (0) | 5 (5) | 0 (0) |
| General disorders and administration-site conditions | ||||
| Fatigue | 30 (14) | 0 (0) | 14 (13) | 0 (0) |
| Gastrointestinal disorders | ||||
| Abdominal painb | 31 (14) | 0 (0) | 13 (12) | 0 (0) |
| Diarrhea | 27 (12) | 1 (<1) | 11 (10) | 0 (0) |
| Nausea | 20 (9) | 0 (0) | 6 (6) | 0 (0) |
| Vascular disorders | ||||
| Hypertensionc | 18 (8) | 4 (2) | 3 (3) | 0 (0) |
| Metabolism and nutrition disorders | ||||
| Hyperuricemia | 16 (7) | 6 (3) | 0 (0) | 0 (0) |
| Respiratory, thoracic, and mediastinal disorders | ||||
| Cough | 32 (14) | 0 (0) | 12 (11) | 0 (0) |
| Body system/ Adverse reaction |
All Grades n (%) |
|
|---|---|---|
| REBLOZYL (n=223) |
Placebo (n=109) |
|
| Musculoskeletal and connective tissue disorders | ||
| Bone pain | 44 (20) | 9 (8) |
| Arthralgia | 43 (19) | 13 (12) |
| Infections and infestations | ||
| Influenza | 19 (9) | 6 (6) |
| Viral upper respiratory infection | 14 (6) | 2 (2) |
| Nervous system disorders | ||
| Headache | 58 (26) | 26 (24) |
| Dizziness | 25 (11) | 5 (5) |
| General disorders and administration-site conditions | ||
| Fatigue | 30 (14) | 14 (13) |
| Gastrointestinal disorders | ||
| Abdominal painb | 31 (14) | 13 (12) |
| Diarrhea | 27 (12) | 11 (10) |
| Nausea | 20 (9) | 6 (6) |
| Vascular disorders | ||
| Hypertensionc | 18 (8) | 3 (3) |
| Metabolism and nutrition disorders | ||
| Hyperuricemia | 16 (7) | 0 (0) |
| Respiratory, thoracic, and mediastinal disorders | ||
| Cough | 32 (14) | 12 (11) |
| Body system/Adverse reaction | Grade ≥3a n (%) |
|
|---|---|---|
| REBLOZYL (n=223) |
Placebo (n=109) |
|
| Musculoskeletal and connective tissue disorders | ||
| Bone pain | 3 (1) | 0 (0) |
| Arthralgia | 0 (0) | 0 (0) |
| Infections and infestations | ||
| Influenza | 0 (0) | 0 (0) |
| Viral upper respiratory infection | 1 (0.4) | 0 (0) |
| Nervous system disorders | ||
| Headache | 1 (<1) | 1 (1) |
| Dizziness | 0 (0) | 0 (0) |
| General disorders and administration-site conditions | ||
| Fatigue | 0 (0) | 0 (0) |
| Gastrointestinal disorders | ||
| Abdominal painb | 0 (0) | 0 (0) |
| Diarrhea | 1 (<1) | 0 (0) |
| Nausea | 0 (0) | 0 (0) |
| Vascular disorders | ||
| Hypertensionc | 4 (2) | 0 (0) |
| Metabolism and nutrition disorders | ||
| Hyperuricemia | 6 (3) | 0 (0) |
| Respiratory, thoracic, and mediastinal disorders | ||
| Cough | 0 (0) | 0 (0) |
aLimited to Grade 3 reactions with the exception of 4 events of Grade 4 hyperuricemia.
bGrouped term includes: Abdominal pain and abdominal pain upper.
cGrouped term includes: Essential hypertension, hypertension, and hypertensive crisis.
The majority of adverse reactions with REBLOZYL were Grade 1 or 2 (mild to moderate)
Important considerations while treating patients with REBLOZYL
Liver function laboratory abnormalities in the BELIEVE trial1
| REBLOZYL (n=223) n (%) |
Placebo (n=109) n (%) |
|
|---|---|---|
| ALT ≥3 x ULN | 26 (12) | 13 (12) |
| AST ≥3 x ULN | 25 (11) | 5 (5) |
| ALP ≥2 x ULN | 17 (8) | 1 (< 1) |
| Total bilirubin ≥2 x ULN | 143 (64) | 51 (47) |
| Direct bilirubin ≥2 x ULN | 13 (6) | 4 (4) |
ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal.
- Of 284 patients with beta-thalassemia who were treated with REBLOZYL and evaluable for the presence of anti–luspatercept-aamt antibodies, 4 patients (1.4%) tested positive for treatment-emergent anti–luspatercept-aamt antibodies, including 2 patients (0.7%) who had neutralizing antibodies
- Luspatercept-aamt serum concentration tended to decrease in the presence of neutralizing antibodies
- There were no severe acute systemic hypersensitivity reactions reported for patients with anti–luspatercept-aamt antibodies in REBLOZYL clinical trials, and there was no association between hypersensitivity type reaction or injection-site reaction and presence of anti–luspatercept-aamt antibodies
- In adult patients with transfusion-dependent beta-thalassemia, EMH masses were observed in 3.2% of REBLOZYL-treated patients, with spinal cord compression symptoms due to EMH masses occurring in 1.9% of patients (BELIEVE and REBLOZYL long-term follow-up study)
- In a study of adult patients with non–transfusion-dependent beta-thalassemia, a higher incidence of EMH masses was observed in 6.3% of REBLOZYL-treated patients vs 2% of placebo-treated patients in the double-blind phase of the study, with spinal cord compression due to EMH masses occurring in 1 patient with a prior history of EMH. REBLOZYL is not indicated for use in patients with non–transfusion-dependent beta-thalassemia
- Possible risk factors for the development of EMH masses in patients with beta-thalassemia include history of EMH masses, splenectomy, splenomegaly, hepatomegaly, or low baseline hemoglobin (<8.5 g/dL). Signs and symptoms may vary depending on the anatomical location. Monitor patients with beta-thalassemia at initiation and during treatment for symptoms and signs or complications resulting from the EMH masses and treat according to clinical guidelines. Discontinue treatment with REBLOZYL in case of serious complications due to EMH masses. Avoid use of REBLOZYL in patients requiring treatment to control the growth of EMH masses
- REBLOZYL was detected in milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk. There are no data on the presence of REBLOZYL in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in the breastfed child, advise patients that breastfeeding is not recommended during treatment with REBLOZYL, and for 3 months after the last dose
Permanent discontinuations due to an adverse reaction (Grade 1-4)
5.4%(n=12/223)
Most frequent adverse reactions requiring permanent discontinuation in patients who received REBLOZYL included arthralgia (1%), back pain (1%), bone pain (<1%), and headache (<1%).
Dosage reductions due to an adverse reaction
2.7%(n=6/223)
Most frequent adverse reactions requiring dosage reduction in >0.5% of patients who received REBLOZYL included hypertension and headache.
Dosage interruptions due to an adverse reaction
15.2%(n=34/223)
Most frequent adverse reactions requiring dosage interruption in >1% of patients who received REBLOZYL included upper respiratory tract infection, ALT increase, and cough.
ALT=alanine aminotransferase.
Additional analyses of adverse events (AEs) by REBLOZYL treatment cycle2:
Proportion of patients with newly experienced AEs that occurred in ≥10% of patients and had a ≥5% higher incidence in the REBLOYZL arm vs placebo by treatment cycle*
- This additional analysis examined the AEs that occurred in ≥10% of patients and had a ≥5% higher incidence in the REBLOZYL arm vs placebo. The AEs that met these requirements included bone pain, arthralgia, and dizziness. The incidence of adverse reactions in the REBLOZYL and placebo arms can be seen in the table above3
Analysis limitations
- All patients in both arms were eligible to receive BSC as needed: RBC transfusions; iron-chelating agents; use of antibiotic, antiviral, and antifungal therapy; and nutritional support1
- AEs were analyzed in terms of treatment-emergent adverse events (TEAEs), which were defined as any AEs that occurred or worsened on or after the start of study drug through 63 days after the last dose of the study drug. In addition, any AE with an onset date beyond this time frame and that was assessed by the investigator as related to the study drug was considered a TEAE. If a subject experienced multiple TEAEs under the same system organ class (SOC) or preferred term (PT), then the subject was counted only once for that SOC or PT3
Additional analysis information
- The BELIEVE trial captured all TEAEs, including all AEs independent of attribution of treatment or disease3
- Patients who crossed over from the placebo arm to the REBLOZYL arm had similar rates of incidence and discontinuation due to these AEs, compared with patients who were initially randomized to the REBLOZYL arm2
- “Newly experienced” is defined as first occurrence of indicated TEAE at the given treatment cycle
BSC=best supportive care; RBC=red blood cell.
Overall incidence and median duration of bone pain, arthralgia, and dizziness1,4
The incidence of all-grade adverse reactions occurring in ≥10% of patients and ≥5% higher in REBLOZYL vs placebo were bone pain (20% vs 8%, respectively), arthralgia (19% vs 12%), and dizziness (11% vs 5%).1,4
| Grade 1/2 ADR | Grade ≥3 ADR | Median duration of TEAE | |
|---|---|---|---|
| Bone pain | 18% (41/223) |
1% (3/223) |
22.0 days (min, max: 1, 413; n=45/223) |
| Arthralgia | 19% (43/223) |
0% (0/223) |
15.0 days (min, max: 1, 524; n=47/223) |
| Dizziness | 11% (25/223) |
0% (0/223) |
6.0 days (min, max: 1, 387; n=27/223) |
| Grade 1/2 ADR | Grade ≥3 ADR | Median duration of TEAE | |
|---|---|---|---|
| Bone pain | 18% (41/223) |
1% (3/223) |
22.0 days (min, max: 1, 413; n=45/223) |
| Arthralgia | 19% (43/223) |
0% (0/223) |
15.0 days (min, max: 1, 524; n=47/223) |
| Dizziness | 11% (25/223) |
0% (0/223) |
6.0 days (min, max: 1, 387; n=27/223) |
ADR=adverse drug reaction.
PATIENT OUTCOMES: REBLOZYL SAFETY
REBLOZYL offers a demonstrated safety profile1
The majority of adverse reactions with REBLOZYL were Grade 1 or 2 (mild to moderate)
- Serious adverse reactions occurred in 3.6% of patients on REBLOZYL
- Serious adverse reactions reported in 1% of patients were cerebrovascular accident and deep vein thrombosis
- A fatal adverse reaction occurred in 1 patient treated with REBLOZYL who died due to an unconfirmed case of acute myeloid leukemia (AML)
- Serious adverse reactions occurred in 3.6% of patients on REBLOZYL
- Serious adverse reactions reported in 1% of patients were cerebrovascular accident and deep vein thrombosis
- A fatal adverse reaction occurred in 1 patient treated with REBLOZYL who died due to an unconfirmed case of acute myeloid leukemia (AML)
Adverse reactions (>5%) in patients with beta-thalassemia receiving REBLOZYL with a difference between arms of 1% in the BELIEVE trial1
| Body system/Adverse reaction | REBLOZYL (n=223) |
Placebo (n=109) |
||
|---|---|---|---|---|
| All Grades n (%) |
Grade 3a n (%) |
All Grades n (%) |
Grade ≥3 n (%) |
|
| Musculoskeletal and connective tissue disorders | ||||
| Bone pain | 44 (20) | 3 (1) | 9 (8) | 0 (0) |
| Arthralgia | 43 (19) | 0 (0) | 13 (12) | 0 (0) |
| Infections and infestations | ||||
| Influenza | 19 (9) | 0 (0) | 6 (6) | 0 (0) |
| Viral upper respiratory infection | 14 (6) | 1 (0.4) | 2 (2) | 0 (0) |
| Nervous system disorders | ||||
| Headache | 58 (26) | 1 (<1) | 26 (24) | 1 (1) |
| Dizziness | 25 (11) | 0 (0) | 5 (5) | 0 (0) |
| General disorders and administration-site conditions | ||||
| Fatigue | 30 (14) | 0 (0) | 14 (13) | 0 (0) |
| Gastrointestinal disorders | ||||
| Abdominal painb | 31 (14) | 0 (0) | 13 (12) | 0 (0) |
| Diarrhea | 27 (12) | 1 (<1) | 11 (10) | 0 (0) |
| Nausea | 20 (9) | 0 (0) | 6 (6) | 0 (0) |
| Vascular disorders | ||||
| Hypertensionc | 18 (8) | 4 (2) | 3 (3) | 0 (0) |
| Metabolism and nutrition disorders | ||||
| Hyperuricemia | 16 (7) | 6 (3) | 0 (0) | 0 (0) |
| Respiratory, thoracic, and mediastinal disorders | ||||
| Cough | 32 (14) | 0 (0) | 12 (11) | 0 (0) |
| Body system/ Adverse reaction |
All Grades n (%) |
|
|---|---|---|
| REBLOZYL (n=223) |
Placebo (n=109) |
|
| Musculoskeletal and connective tissue disorders | ||
| Bone pain | 44 (20) | 9 (8) |
| Arthralgia | 43 (19) | 13 (12) |
| Infections and infestations | ||
| Influenza | 19 (9) | 6 (6) |
| Viral upper respiratory infection | 14 (6) | 2 (2) |
| Nervous system disorders | ||
| Headache | 58 (26) | 26 (24) |
| Dizziness | 25 (11) | 5 (5) |
| General disorders and administration-site conditions | ||
| Fatigue | 30 (14) | 14 (13) |
| Gastrointestinal disorders | ||
| Abdominal painb | 31 (14) | 13 (12) |
| Diarrhea | 27 (12) | 11 (10) |
| Nausea | 20 (9) | 6 (6) |
| Vascular disorders | ||
| Hypertensionc | 18 (8) | 3 (3) |
| Metabolism and nutrition disorders | ||
| Hyperuricemia | 16 (7) | 0 (0) |
| Respiratory, thoracic, and mediastinal disorders | ||
| Cough | 32 (14) | 12 (11) |
| Body system/Adverse reaction | Grade ≥3a n (%) |
|
|---|---|---|
| REBLOZYL (n=223) |
Placebo (n=109) |
|
| Musculoskeletal and connective tissue disorders | ||
| Bone pain | 3 (1) | 0 (0) |
| Arthralgia | 0 (0) | 0 (0) |
| Infections and infestations | ||
| Influenza | 0 (0) | 0 (0) |
| Viral upper respiratory infection | 1 (0.4) | 0 (0) |
| Nervous system disorders | ||
| Headache | 1 (<1) | 1 (1) |
| Dizziness | 0 (0) | 0 (0) |
| General disorders and administration-site conditions | ||
| Fatigue | 0 (0) | 0 (0) |
| Gastrointestinal disorders | ||
| Abdominal painb | 0 (0) | 0 (0) |
| Diarrhea | 1 (<1) | 0 (0) |
| Nausea | 0 (0) | 0 (0) |
| Vascular disorders | ||
| Hypertensionc | 4 (2) | 0 (0) |
| Metabolism and nutrition disorders | ||
| Hyperuricemia | 6 (3) | 0 (0) |
| Respiratory, thoracic, and mediastinal disorders | ||
| Cough | 0 (0) | 0 (0) |
aLimited to Grade 3 reactions with the exception of 4 events of Grade 4 hyperuricemia.
bGrouped term includes: Abdominal pain and abdominal pain upper.
cGrouped term includes: Essential hypertension, hypertension, and hypertensive crisis.
The majority of adverse reactions with REBLOZYL were Grade 1 or 2 (mild to moderate)
Important considerations while treating patients with REBLOZYL
Liver function laboratory abnormalities in the BELIEVE trial1
| REBLOZYL (n=223) n (%) |
Placebo (n=109) n (%) |
|
|---|---|---|
| ALT ≥3 x ULN | 26 (12) | 13 (12) |
| AST ≥3 x ULN | 25 (11) | 5 (5) |
| ALP ≥2 x ULN | 17 (8) | 1 (< 1) |
| Total bilirubin ≥2 x ULN | 143 (64) | 51 (47) |
| Direct bilirubin ≥2 x ULN | 13 (6) | 4 (4) |
ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal.
- Of 284 patients with beta-thalassemia who were treated with REBLOZYL and evaluable for the presence of anti–luspatercept-aamt antibodies, 4 patients (1.4%) tested positive for treatment-emergent anti–luspatercept-aamt antibodies, including 2 patients (0.7%) who had neutralizing antibodies
- Luspatercept-aamt serum concentration tended to decrease in the presence of neutralizing antibodies
- There were no severe acute systemic hypersensitivity reactions reported for patients with anti–luspatercept-aamt antibodies in REBLOZYL clinical trials, and there was no association between hypersensitivity type reaction or injection-site reaction and presence of anti–luspatercept-aamt antibodies
- In adult patients with transfusion-dependent beta-thalassemia, EMH masses were observed in 3.2% of REBLOZYL-treated patients, with spinal cord compression symptoms due to EMH masses occurring in 1.9% of patients (BELIEVE and REBLOZYL long-term follow-up study)
- In a study of adult patients with non–transfusion-dependent beta-thalassemia, a higher incidence of EMH masses was observed in 6.3% of REBLOZYL-treated patients vs 2% of placebo-treated patients in the double-blind phase of the study, with spinal cord compression due to EMH masses occurring in 1 patient with a prior history of EMH. REBLOZYL is not indicated for use in patients with non–transfusion-dependent beta-thalassemia
- Possible risk factors for the development of EMH masses in patients with beta-thalassemia include history of EMH masses, splenectomy, splenomegaly, hepatomegaly, or low baseline hemoglobin (<8.5 g/dL). Signs and symptoms may vary depending on the anatomical location. Monitor patients with beta-thalassemia at initiation and during treatment for symptoms and signs or complications resulting from the EMH masses and treat according to clinical guidelines. Discontinue treatment with REBLOZYL in case of serious complications due to EMH masses. Avoid use of REBLOZYL in patients requiring treatment to control the growth of EMH masses
- REBLOZYL was detected in milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk. There are no data on the presence of REBLOZYL in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in the breastfed child, advise patients that breastfeeding is not recommended during treatment with REBLOZYL, and for 3 months after the last dose
Permanent discontinuations due to an adverse reaction (Grade 1-4)
5.4%(n=12/223)
Most frequent adverse reactions requiring permanent discontinuation in patients who received REBLOZYL included arthralgia (1%), back pain (1%), bone pain (<1%), and headache (<1%).
Dosage reductions due to an adverse reaction
2.7%(n=6/223)
Most frequent adverse reactions requiring dosage reduction in >0.5% of patients who received REBLOZYL included hypertension and headache.
Dosage interruptions due to an adverse reaction
15.2%(n=34/223)
Most frequent adverse reactions requiring dosage interruption in >1% of patients who received REBLOZYL included upper respiratory tract infection, ALT increase, and cough.
ALT=alanine aminotransferase.
Additional analyses of adverse events (AEs) by REBLOZYL treatment cycle2:
Proportion of patients with newly experienced AEs that occurred in ≥10% of patients and had a ≥5% higher incidence in the REBLOYZL arm vs placebo by treatment cycle*
- This additional analysis examined the AEs that occurred in ≥10% of patients and had a ≥5% higher incidence in the REBLOZYL arm vs placebo. The AEs that met these requirements included bone pain, arthralgia, and dizziness. The incidence of adverse reactions in the REBLOZYL and placebo arms can be seen in the table above3
Analysis limitations
- All patients in both arms were eligible to receive BSC as needed: RBC transfusions; iron-chelating agents; use of antibiotic, antiviral, and antifungal therapy; and nutritional support1
- AEs were analyzed in terms of treatment-emergent adverse events (TEAEs), which were defined as any AEs that occurred or worsened on or after the start of study drug through 63 days after the last dose of the study drug. In addition, any AE with an onset date beyond this time frame and that was assessed by the investigator as related to the study drug was considered a TEAE. If a subject experienced multiple TEAEs under the same system organ class (SOC) or preferred term (PT), then the subject was counted only once for that SOC or PT3
Additional analysis information
- The BELIEVE trial captured all TEAEs, including all AEs independent of attribution of treatment or disease3
- Patients who crossed over from the placebo arm to the REBLOZYL arm had similar rates of incidence and discontinuation due to these AEs, compared with patients who were initially randomized to the REBLOZYL arm2
- “Newly experienced” is defined as first occurrence of indicated TEAE at the given treatment cycle
BSC=best supportive care; RBC=red blood cell.
Overall incidence and median duration of bone pain, arthralgia, and dizziness1,4
The incidence of all-grade adverse reactions occurring in ≥10% of patients and ≥5% higher in REBLOZYL vs placebo were bone pain (20% vs 8%, respectively), arthralgia (19% vs 12%), and dizziness (11% vs 5%).1,4
| Grade 1/2 ADR | Grade ≥3 ADR | Median duration of TEAE | |
|---|---|---|---|
| Bone pain | 18% (41/223) |
1% (3/223) |
22.0 days (min, max: 1, 413; n=45/223) |
| Arthralgia | 19% (43/223) |
0% (0/223) |
15.0 days (min, max: 1, 524; n=47/223) |
| Dizziness | 11% (25/223) |
0% (0/223) |
6.0 days (min, max: 1, 387; n=27/223) |
| Grade 1/2 ADR | Grade ≥3 ADR | Median duration of TEAE | |
|---|---|---|---|
| Bone pain | 18% (41/223) |
1% (3/223) |
22.0 days (min, max: 1, 413; n=45/223) |
| Arthralgia | 19% (43/223) |
0% (0/223) |
15.0 days (min, max: 1, 524; n=47/223) |
| Dizziness | 11% (25/223) |
0% (0/223) |
6.0 days (min, max: 1, 387; n=27/223) |
ADR=adverse drug reaction.