Time Frame |
Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
|
Adverse Event Reporting Description |
Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.
|
|
Arm/Group Title
|
SGI-110 (Guadecitabine)
|
Treatment Choice
|
Arm/Group Description |
Guadecitabine 60 mg/m^2 was adminis...
|
One of the following treatment regi...
|
Arm/Group Description |
Guadecitabine 60 mg/m^2 was administered subcutaneously daily for 5 days (Days 1-5) in 28-day cycles.
|
One of the following treatment regimens were administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.
|
|
|
SGI-110 (Guadecitabine)
|
Treatment Choice
|
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Total |
341/408 (83.58%)
|
|
344/407 (84.52%)
|
|
|
|
SGI-110 (Guadecitabine)
|
Treatment Choice
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
327/401 (81.55%)
|
|
297/392 (75.77%)
|
|
Blood and lymphatic system disorders |
|
|
Agranulocytosis |
1/401 (0.25%)
|
1 |
1/392 (0.26%)
|
1 |
Anemia |
1/401 (0.25%)
|
1 |
1/392 (0.26%)
|
1 |
Disseminated intravascular coagulation |
2/401 (0.50%)
|
2 |
0/392 (0.00%)
|
0 |
Febrile bone marrow aplasia |
3/401 (0.75%)
|
3 |
4/392 (1.02%)
|
4 |
Febrile neutropenia |
101/401 (25.19%)
|
147 |
88/392 (22.45%)
|
138 |
Hemorrhagic diathesis |
2/401 (0.50%)
|
3 |
0/392 (0.00%)
|
0 |
Histiocytosis hematophagic |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Leukocytosis |
6/401 (1.50%)
|
7 |
2/392 (0.51%)
|
2 |
Lymphoadenopathy |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Lymphoadenopathy mediastinal |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Monoclonal B-cell lymphocytosis |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Neutropenia |
2/401 (0.50%)
|
2 |
2/392 (0.51%)
|
2 |
Pancytopenia |
2/401 (0.50%)
|
2 |
1/392 (0.26%)
|
1 |
Splenic infarction |
0/401 (0.00%)
|
0 |
2/392 (0.51%)
|
2 |
Thrombocytopenia |
15/401 (3.74%)
|
15 |
5/392 (1.28%)
|
5 |
Cardiac disorders |
|
|
Acute coronary syndrome |
3/401 (0.75%)
|
3 |
0/392 (0.00%)
|
0 |
Acute myocardial infarction |
3/401 (0.75%)
|
6 |
3/392 (0.77%)
|
3 |
Angina pectoris |
3/401 (0.75%)
|
4 |
4/392 (1.02%)
|
4 |
Arrhythmia |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Atrial fibrillation |
5/401 (1.25%)
|
5 |
6/392 (1.53%)
|
13 |
Atrial flutter |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Atrial tachycardia |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Atrioventricular block complete |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Cardiac arrest |
3/401 (0.75%)
|
3 |
9/392 (2.30%)
|
9 |
Cardiac failure |
8/401 (2.00%)
|
8 |
10/392 (2.55%)
|
11 |
Cardiac failure acute |
1/401 (0.25%)
|
1 |
1/392 (0.26%)
|
1 |
Cardiac failure chronic |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Cardiac failure congestive |
4/401 (1.00%)
|
7 |
3/392 (0.77%)
|
3 |
Cardiac tamponade |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Cardio-respiratory arrest |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Cardiogenic shock |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Cardiopulmonary failure |
2/401 (0.50%)
|
2 |
1/392 (0.26%)
|
1 |
Cardiorenal syndrome |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Cardiovascular insufficiency |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Coronary artery stenosis |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Myocardial infarction |
1/401 (0.25%)
|
1 |
3/392 (0.77%)
|
3 |
Pericardial effusion |
0/401 (0.00%)
|
0 |
2/392 (0.51%)
|
2 |
Pericarditis |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Sinus node dysfunction |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Supraventricular tachycardia |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Ear and labyrinth disorders |
|
|
Mastoid disorder |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Sudden hearing loss |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Vertigo |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Endocrine disorders |
|
|
Diabetes insipidus |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Inappropriate antidiuretic hormone secretion |
1/401 (0.25%)
|
1 |
1/392 (0.26%)
|
1 |
Gastrointestinal disorders |
|
|
Abdominal pain |
4/401 (1.00%)
|
4 |
2/392 (0.51%)
|
2 |
Abdominal pain upper |
0/401 (0.00%)
|
0 |
2/392 (0.51%)
|
2 |
Anal fissure |
1/401 (0.25%)
|
2 |
1/392 (0.26%)
|
1 |
Anal fistula |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Colitis |
3/401 (0.75%)
|
4 |
2/392 (0.51%)
|
2 |
Colitis ischemic |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Constipation |
2/401 (0.50%)
|
2 |
1/392 (0.26%)
|
2 |
Diarrhea |
8/401 (2.00%)
|
9 |
7/392 (1.79%)
|
10 |
Diverticular perforation |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Diverticulum |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Dyspepsia |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Dysphagia |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Enteritis |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Fecaloma |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Gastric hemorrhage |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Gastrointestinal hemorrhage |
2/401 (0.50%)
|
3 |
1/392 (0.26%)
|
2 |
Hemorrhoids |
1/401 (0.25%)
|
1 |
1/392 (0.26%)
|
1 |
Ileus |
2/401 (0.50%)
|
2 |
0/392 (0.00%)
|
0 |
Ileus paralytic |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Incarcerated inguinal hernia |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Intestinal perforation |
0/401 (0.00%)
|
0 |
2/392 (0.51%)
|
2 |
Intussusception |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Melaena |
3/401 (0.75%)
|
3 |
2/392 (0.51%)
|
2 |
Mesenteric artery thrombosis |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Nausea |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Neutropenic colitis |
1/401 (0.25%)
|
1 |
1/392 (0.26%)
|
1 |
Esophagitis |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Pancreatitis |
2/401 (0.50%)
|
2 |
0/392 (0.00%)
|
0 |
Pneumatosis intestinalis |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Proctalgia |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Rectal hemorrhage |
2/401 (0.50%)
|
2 |
4/392 (1.02%)
|
4 |
Small intestinal hemorrhage |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Small intestinal obstruction |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Stomatitis |
3/401 (0.75%)
|
3 |
1/392 (0.26%)
|
1 |
Tooth disorder |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Vomiting |
2/401 (0.50%)
|
2 |
1/392 (0.26%)
|
2 |
General disorders |
|
|
Asthenia |
2/401 (0.50%)
|
2 |
4/392 (1.02%)
|
4 |
Catheter site erythema |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Chest pain |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Death |
5/401 (1.25%)
|
5 |
5/392 (1.28%)
|
5 |
Device related thrombosis |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Discomfort |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Fatigue |
1/401 (0.25%)
|
1 |
1/392 (0.26%)
|
1 |
Gait disturbance |
0/401 (0.00%)
|
0 |
2/392 (0.51%)
|
2 |
General physical health deterioration |
9/401 (2.24%)
|
9 |
10/392 (2.55%)
|
10 |
Impaired healing |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Injection site reaction |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Malaise |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Multiple organ dysfunction syndrome |
5/401 (1.25%)
|
5 |
4/392 (1.02%)
|
4 |
Non-cardiac chest pain |
2/401 (0.50%)
|
2 |
0/392 (0.00%)
|
0 |
Edema peripheral |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Pyrexia |
16/401 (3.99%)
|
19 |
13/392 (3.32%)
|
14 |
Sudden cardiac death |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Sudden death |
0/401 (0.00%)
|
0 |
2/392 (0.51%)
|
2 |
Systemic inflammatory response syndrome |
1/401 (0.25%)
|
1 |
1/392 (0.26%)
|
2 |
Hepatobiliary disorders |
|
|
Biliary colic |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Cholangitis |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Cholecystitis acute |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Gallbladder obstruction |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Hepatitis acute |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Ischemic hepatitis |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Jaundice cholestatic |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Portal vein thrombosis |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Immune system disorders |
|
|
Anaphylactic reaction |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Infections and infestations |
|
|
Abdominal wall abscess |
1/401 (0.25%)
|
2 |
0/392 (0.00%)
|
0 |
Abscess intestinal |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Anal abscess |
3/401 (0.75%)
|
3 |
1/392 (0.26%)
|
1 |
Appendicitis |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Arthritis bacterial |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Aspergillus infection |
3/401 (0.75%)
|
3 |
0/392 (0.00%)
|
0 |
Atypical pneumonia |
0/401 (0.00%)
|
0 |
2/392 (0.51%)
|
2 |
Bacteremia |
7/401 (1.75%)
|
8 |
2/392 (0.51%)
|
2 |
Bacterial infection |
2/401 (0.50%)
|
2 |
1/392 (0.26%)
|
1 |
Bacteroides bacteremia |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Bronchitis |
6/401 (1.50%)
|
6 |
2/392 (0.51%)
|
2 |
Bronchopulmonary aspergillosis |
2/401 (0.50%)
|
2 |
2/392 (0.51%)
|
2 |
Campylobacter gastroenteritis |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Cellulitis |
3/401 (0.75%)
|
4 |
6/392 (1.53%)
|
7 |
Cellulitis orbital |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Cellulitis staphylococcal |
1/401 (0.25%)
|
1 |
1/392 (0.26%)
|
1 |
Clostridium colitis |
1/401 (0.25%)
|
2 |
0/392 (0.00%)
|
0 |
Clostridium difficile colitis |
4/401 (1.00%)
|
4 |
2/392 (0.51%)
|
3 |
Clostridium difficile infection |
4/401 (1.00%)
|
5 |
2/392 (0.51%)
|
2 |
Cystitis |
3/401 (0.75%)
|
3 |
0/392 (0.00%)
|
0 |
Dermo-hypodermitis |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Device related infection |
4/401 (1.00%)
|
4 |
7/392 (1.79%)
|
8 |
Device related sepsis |
2/401 (0.50%)
|
2 |
2/392 (0.51%)
|
2 |
Diverticulitis |
4/401 (1.00%)
|
6 |
1/392 (0.26%)
|
1 |
Encephalomyelitis |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Endocarditis |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Enterobacter infection |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Epiglottitis |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Erysipelas |
2/401 (0.50%)
|
2 |
2/392 (0.51%)
|
2 |
Escherichia bacteremia |
2/401 (0.50%)
|
2 |
0/392 (0.00%)
|
0 |
Escherichia infection |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Escherichia urinary tract infection |
2/401 (0.50%)
|
2 |
2/392 (0.51%)
|
2 |
Eye infection |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Febrile infection |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Gastric infection |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Gastroenteritis |
2/401 (0.50%)
|
2 |
2/392 (0.51%)
|
2 |
Gastroenteritis pseudomonas |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Gastroenteritis viral |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Gingivitis |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
H1N1 influenza |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Hematoma infection |
2/401 (0.50%)
|
2 |
0/392 (0.00%)
|
0 |
Hepatosplenic abscess |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Herpes simplex |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Herpes zoster |
1/401 (0.25%)
|
1 |
1/392 (0.26%)
|
1 |
Herpes zoster oticus |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Infection |
6/401 (1.50%)
|
6 |
5/392 (1.28%)
|
6 |
Infectious colitis |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Influenza |
6/401 (1.50%)
|
6 |
3/392 (0.77%)
|
3 |
Injection site abscess |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Injection site cellulitis |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Injection site infection |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Kidney infection |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Klebsiella infection |
3/401 (0.75%)
|
3 |
0/392 (0.00%)
|
0 |
Liver abscess |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Localized infection |
2/401 (0.50%)
|
2 |
1/392 (0.26%)
|
1 |
Lower respiratory tract infection |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Mastoiditis |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Mucormycosis |
1/401 (0.25%)
|
1 |
1/392 (0.26%)
|
1 |
Muscle abscess |
1/401 (0.25%)
|
1 |
1/392 (0.26%)
|
1 |
Neutropenic infection |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Osteomyelitis |
1/401 (0.25%)
|
1 |
1/392 (0.26%)
|
1 |
Otitis media |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Otitis media acute |
1/401 (0.25%)
|
1 |
1/392 (0.26%)
|
1 |
Parotitis |
2/401 (0.50%)
|
3 |
0/392 (0.00%)
|
0 |
Pathogen resistance |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Periorbital cellulitis |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Peritonitis |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Periumbilical abscess |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Pharyngitis |
2/401 (0.50%)
|
2 |
1/392 (0.26%)
|
2 |
Pneumocystis jirovecii pneumonia |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Pneumonia |
117/401 (29.18%)
|
147 |
79/392 (20.15%)
|
102 |
Pneumonia cytomegaloviral |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Pneumonia influenzal |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Pneumonia legionella |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Pneumonia pseudomonal |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Post procedural cellulitis |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Postoperative wound infection |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Pseudomembranous colitis |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Pseudomonal sepsis |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Pseudomonas infection |
2/401 (0.50%)
|
2 |
0/392 (0.00%)
|
0 |
Pulmonary tuberculosis |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Pulpitis dental |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Pyelonephritis |
2/401 (0.50%)
|
2 |
2/392 (0.51%)
|
2 |
Pyelonephritis acute |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Rectal abscess |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Respiratory syncytial virus infection |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Respiratory tract infection |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Scrotal infection |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Sepsis |
62/401 (15.46%)
|
83 |
44/392 (11.22%)
|
58 |
Septic shock |
16/401 (3.99%)
|
17 |
17/392 (4.34%)
|
19 |
Septic vasculitis |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Sinusitis |
0/401 (0.00%)
|
0 |
4/392 (1.02%)
|
4 |
Sinusitis fungal |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Skin infection |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Soft tissue infection |
3/401 (0.75%)
|
3 |
2/392 (0.51%)
|
2 |
Staphylococcal bacteremia |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Staphylococcal infection |
1/401 (0.25%)
|
1 |
1/392 (0.26%)
|
1 |
Staphylococcal sepsis |
2/401 (0.50%)
|
2 |
3/392 (0.77%)
|
3 |
Streptococcal bacteremia |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Systemic candida |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Systemic infection |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Tonsillitis |
1/401 (0.25%)
|
1 |
1/392 (0.26%)
|
1 |
Tooth infection |
2/401 (0.50%)
|
3 |
1/392 (0.26%)
|
1 |
Tuberculous pleurisy |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Upper respiratory tract infection |
4/401 (1.00%)
|
4 |
1/392 (0.26%)
|
1 |
Urethritis |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Urinary tract infection |
14/401 (3.49%)
|
16 |
10/392 (2.55%)
|
11 |
Urinary tract infection enterococcal |
3/401 (0.75%)
|
3 |
0/392 (0.00%)
|
0 |
Urosepsis |
3/401 (0.75%)
|
3 |
0/392 (0.00%)
|
0 |
Viral infection |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Wound infection |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Wound infection staphylococcal |
2/401 (0.50%)
|
2 |
0/392 (0.00%)
|
0 |
Bronchopulmonary aspergillosis allergic |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Urinary tract infection staphylococcal |
1/401 (0.25%)
|
1 |
1/392 (0.26%)
|
1 |
Injury, poisoning and procedural complications |
|
|
Allergic transfusion reaction |
1/401 (0.25%)
|
2 |
1/392 (0.26%)
|
1 |
Ankle fracture |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Concussion |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Contusion |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Craniocerebral injury |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Fall |
1/401 (0.25%)
|
1 |
2/392 (0.51%)
|
2 |
Femur fracture |
2/401 (0.50%)
|
2 |
1/392 (0.26%)
|
1 |
Fibula fracture |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Fracture |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Hemolytic transfusion reaction |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Head injury |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Hip fracture |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Humerus fracture |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Infusion related reaction |
1/401 (0.25%)
|
1 |
1/392 (0.26%)
|
1 |
Joint dislocation |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Pelvic fracture |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Rib fracture |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Spinal compression fracture |
1/401 (0.25%)
|
1 |
2/392 (0.51%)
|
2 |
Splenic rupture |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Subarachnoid hemorrhage |
1/401 (0.25%)
|
1 |
1/392 (0.26%)
|
1 |
Subdural hematoma |
2/401 (0.50%)
|
2 |
1/392 (0.26%)
|
1 |
Subdural hemorrhage |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Tibia fracture |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Transfusion reaction |
4/401 (1.00%)
|
4 |
0/392 (0.00%)
|
0 |
Traumatic lung injury |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
2 |
Upper limb fracture |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Investigations |
|
|
Blood bilirubin increased |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
C-reactive protein increased |
3/401 (0.75%)
|
3 |
3/392 (0.77%)
|
3 |
Influenza A virus test positive |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Metabolism and nutrition disorders |
|
|
Decreased appetite |
2/401 (0.50%)
|
2 |
0/392 (0.00%)
|
0 |
Dehydration |
2/401 (0.50%)
|
2 |
4/392 (1.02%)
|
4 |
Failure to thrive |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Hypercalcemia |
1/401 (0.25%)
|
2 |
0/392 (0.00%)
|
0 |
Hyperglycemia |
1/401 (0.25%)
|
1 |
2/392 (0.51%)
|
2 |
Hypoglycemia |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Hypokalemia |
2/401 (0.50%)
|
2 |
4/392 (1.02%)
|
5 |
Hyponatremia |
1/401 (0.25%)
|
1 |
3/392 (0.77%)
|
4 |
Tumor lysis syndrome |
5/401 (1.25%)
|
5 |
2/392 (0.51%)
|
2 |
Musculoskeletal and connective tissue disorders |
|
|
Arthritis |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Back pain |
0/401 (0.00%)
|
0 |
2/392 (0.51%)
|
2 |
Bone pain |
2/401 (0.50%)
|
2 |
0/392 (0.00%)
|
0 |
Bursitis |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Intervertebral disc protrusion |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Joint effusion |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Lumbar spinal stenosis |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Muscle atrophy |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Muscle hemorrhage |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Musculoskeletal pain |
0/401 (0.00%)
|
0 |
2/392 (0.51%)
|
2 |
Neck pain |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Osteoarthritis |
2/401 (0.50%)
|
2 |
2/392 (0.51%)
|
3 |
Osteonecrosis |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Pain in extremity |
1/401 (0.25%)
|
1 |
2/392 (0.51%)
|
2 |
Rhabdomyolysis |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Shoulder deformity |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Spinal pain |
0/401 (0.00%)
|
0 |
2/392 (0.51%)
|
2 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
B-cell lymphoma |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Basal cell carcinoma |
2/401 (0.50%)
|
2 |
0/392 (0.00%)
|
0 |
Bile duct cancer |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Biliary neoplasm |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Central nervous system leukemia |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Chloroma |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Endometrial cancer metastatic |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Kaposi's sarcoma |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Lung adenocarcinoma |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Metastatic squamous cell carcinoma |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Squamous cell carcinoma |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Transitional cell carcinoma |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Tumor associated fever |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Nervous system disorders |
|
|
Cerebral hemorrhage |
1/401 (0.25%)
|
1 |
2/392 (0.51%)
|
2 |
Cerebrovascular accident |
6/401 (1.50%)
|
6 |
2/392 (0.51%)
|
2 |
Depressed level of consciousness |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Epilepsy |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Facial paralysis |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Hemorrhage intracranial |
1/401 (0.25%)
|
1 |
4/392 (1.02%)
|
5 |
Hemorrhagic stroke |
1/401 (0.25%)
|
1 |
1/392 (0.26%)
|
1 |
Headache |
1/401 (0.25%)
|
1 |
1/392 (0.26%)
|
1 |
Intracranial hematoma |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Ischemic stroke |
2/401 (0.50%)
|
2 |
1/392 (0.26%)
|
1 |
Lethargy |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Nervous system disorder |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Peroneal nerve palsy |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Presyncope |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
2 |
Seizure |
2/401 (0.50%)
|
2 |
2/392 (0.51%)
|
2 |
Syncope |
2/401 (0.50%)
|
2 |
4/392 (1.02%)
|
6 |
Transient ischemic attack |
1/401 (0.25%)
|
1 |
2/392 (0.51%)
|
2 |
Vocal cord paralysis |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Product Issues |
|
|
Device dislocation |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Psychiatric disorders |
|
|
Confusional state |
4/401 (1.00%)
|
4 |
0/392 (0.00%)
|
0 |
Delirium |
1/401 (0.25%)
|
1 |
1/392 (0.26%)
|
1 |
Depression |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Personality change |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Suicide attempt |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Renal and urinary disorders |
|
|
Acute kidney injury |
11/401 (2.74%)
|
11 |
15/392 (3.83%)
|
16 |
Chronic kidney disease |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Cystitis hemorrhagic |
1/401 (0.25%)
|
2 |
0/392 (0.00%)
|
0 |
Hematuria |
2/401 (0.50%)
|
2 |
2/392 (0.51%)
|
2 |
Renal colic |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Renal failure |
4/401 (1.00%)
|
4 |
2/392 (0.51%)
|
2 |
Ureterolithiasis |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Urinary retention |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Urinary tract obstruction |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Respiratory, thoracic and mediastinal disorders |
|
|
Acute pulmonary edema |
2/401 (0.50%)
|
2 |
1/392 (0.26%)
|
1 |
Acute respiratory distress syndrome |
2/401 (0.50%)
|
2 |
0/392 (0.00%)
|
0 |
Acute respiratory failure |
2/401 (0.50%)
|
2 |
6/392 (1.53%)
|
6 |
Aspiration |
1/401 (0.25%)
|
1 |
2/392 (0.51%)
|
2 |
Asthma |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Chronic obstructive pulmonary disease |
2/401 (0.50%)
|
3 |
1/392 (0.26%)
|
1 |
Dyspnea |
2/401 (0.50%)
|
2 |
2/392 (0.51%)
|
2 |
Epistaxis |
3/401 (0.75%)
|
3 |
3/392 (0.77%)
|
3 |
Hemoptysis |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Interstitial lung disease |
1/401 (0.25%)
|
1 |
1/392 (0.26%)
|
1 |
Laryngeal inflammation |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Laryngeal edema |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Organizing pneumonia |
2/401 (0.50%)
|
2 |
1/392 (0.26%)
|
1 |
Oropharyngeal pain |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Pleural effusion |
6/401 (1.50%)
|
7 |
3/392 (0.77%)
|
3 |
Pleuritic pain |
1/401 (0.25%)
|
1 |
1/392 (0.26%)
|
1 |
Pneumonia aspiration |
1/401 (0.25%)
|
1 |
1/392 (0.26%)
|
1 |
Pneumonitis |
3/401 (0.75%)
|
3 |
0/392 (0.00%)
|
0 |
Pulmonary alveolar hemorrhage |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Pulmonary embolism |
2/401 (0.50%)
|
2 |
0/392 (0.00%)
|
0 |
Pulmonary hemorrhage |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Pulmonary mass |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Pulmonary edema |
5/401 (1.25%)
|
5 |
1/392 (0.26%)
|
1 |
Respiratory distress |
2/401 (0.50%)
|
2 |
1/392 (0.26%)
|
1 |
Respiratory failure |
5/401 (1.25%)
|
5 |
2/392 (0.51%)
|
2 |
Stridor |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Skin and subcutaneous tissue disorders |
|
|
Acute febrile neutrophilic dermatosis |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Angioedema |
2/401 (0.50%)
|
2 |
0/392 (0.00%)
|
0 |
Dermatitis |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Eczema |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Hypersensitivity vasculitis |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Pyoderma gangrenosum |
1/401 (0.25%)
|
3 |
0/392 (0.00%)
|
0 |
Rash generalized |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Rash maculo-papular |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Skin disorder |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Skin ulcer |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Toxic skin eruption |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Vascular disorders |
|
|
Aortic aneurysm |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Aortic dissection |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Artery dissection |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Circulatory collapse |
5/401 (1.25%)
|
5 |
4/392 (1.02%)
|
4 |
Deep vein thrombosis |
2/401 (0.50%)
|
2 |
0/392 (0.00%)
|
0 |
Hematoma |
3/401 (0.75%)
|
3 |
1/392 (0.26%)
|
2 |
Hypertension |
0/401 (0.00%)
|
0 |
2/392 (0.51%)
|
2 |
Hypotension |
2/401 (0.50%)
|
2 |
3/392 (0.77%)
|
3 |
Iliac artery embolism |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Leriche syndrome |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Lupus vasculitis |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Orthostatic hypotension |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Peripheral arterial occlusive disease |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Phlebitis |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Shock |
1/401 (0.25%)
|
1 |
0/392 (0.00%)
|
0 |
Shock hemorrhagic |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Thrombophlebitis |
2/401 (0.50%)
|
2 |
0/392 (0.00%)
|
0 |
Venous thrombosis |
0/401 (0.00%)
|
0 |
1/392 (0.26%)
|
1 |
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
|
|
Frequency Threshold for Reporting Other Adverse Events
|
5%
|
|
SGI-110 (Guadecitabine)
|
Treatment Choice
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
379/401 (94.51%)
|
|
371/392 (94.64%)
|
|
Blood and lymphatic system disorders |
|
|
Anemia |
88/401 (21.95%)
|
211 |
78/392 (19.90%)
|
201 |
Febrile neutropenia |
66/401 (16.46%)
|
103 |
40/392 (10.20%)
|
57 |
Leukopenia |
37/401 (9.23%)
|
120 |
33/392 (8.42%)
|
124 |
Neutropenia |
115/401 (28.68%)
|
319 |
88/392 (22.45%)
|
233 |
Thrombocytopenia |
116/401 (28.93%)
|
380 |
101/392 (25.77%)
|
313 |
Gastrointestinal disorders |
|
|
Abdominal pain |
30/401 (7.48%)
|
43 |
46/392 (11.73%)
|
50 |
Abdominal pain upper |
21/401 (5.24%)
|
25 |
15/392 (3.83%)
|
16 |
Constipation |
125/401 (31.17%)
|
166 |
114/392 (29.08%)
|
168 |
Diarrhea |
122/401 (30.42%)
|
169 |
83/392 (21.17%)
|
116 |
Hemorrhoids |
24/401 (5.99%)
|
28 |
19/392 (4.85%)
|
24 |
Nausea |
91/401 (22.69%)
|
141 |
108/392 (27.55%)
|
150 |
Stomatitis |
46/401 (11.47%)
|
59 |
38/392 (9.69%)
|
44 |
Vomiting |
58/401 (14.46%)
|
80 |
66/392 (16.84%)
|
82 |
General disorders |
|
|
Asthenia |
61/401 (15.21%)
|
102 |
55/392 (14.03%)
|
81 |
Fatigue |
63/401 (15.71%)
|
97 |
50/392 (12.76%)
|
74 |
Injection site reaction |
73/401 (18.20%)
|
148 |
48/392 (12.24%)
|
75 |
Edema peripheral |
95/401 (23.69%)
|
125 |
78/392 (19.90%)
|
108 |
Pain |
21/401 (5.24%)
|
22 |
14/392 (3.57%)
|
14 |
Pyrexia |
89/401 (22.19%)
|
155 |
110/392 (28.06%)
|
176 |
Infections and infestations |
|
|
Bronchitis |
22/401 (5.49%)
|
30 |
13/392 (3.32%)
|
15 |
Cellulitis |
29/401 (7.23%)
|
37 |
22/392 (5.61%)
|
25 |
Nasopharyngitis |
18/401 (4.49%)
|
27 |
20/392 (5.10%)
|
21 |
Oral candidiasis |
23/401 (5.74%)
|
27 |
17/392 (4.34%)
|
21 |
Oral herpes |
31/401 (7.73%)
|
36 |
20/392 (5.10%)
|
21 |
Pneumonia |
54/401 (13.47%)
|
64 |
31/392 (7.91%)
|
34 |
Upper respiratory tract infection |
22/401 (5.49%)
|
34 |
20/392 (5.10%)
|
28 |
Urinary tract infection |
33/401 (8.23%)
|
46 |
28/392 (7.14%)
|
39 |
Injury, poisoning and procedural complications |
|
|
Contusion |
20/401 (4.99%)
|
23 |
22/392 (5.61%)
|
27 |
Fall |
34/401 (8.48%)
|
43 |
29/392 (7.40%)
|
37 |
Investigations |
|
|
Weight decreased |
35/401 (8.73%)
|
47 |
25/392 (6.38%)
|
28 |
Metabolism and nutrition disorders |
|
|
Decreased appetite |
89/401 (22.19%)
|
116 |
62/392 (15.82%)
|
80 |
Hyperkalemia |
24/401 (5.99%)
|
33 |
13/392 (3.32%)
|
19 |
Hypoalbuminemia |
26/401 (6.48%)
|
36 |
23/392 (5.87%)
|
43 |
Hypocalcemia |
25/401 (6.23%)
|
30 |
18/392 (4.59%)
|
29 |
Hypokalemia |
96/401 (23.94%)
|
173 |
77/392 (19.64%)
|
128 |
Hypomagnesemia |
31/401 (7.73%)
|
50 |
27/392 (6.89%)
|
36 |
Musculoskeletal and connective tissue disorders |
|
|
Arthralgia |
24/401 (5.99%)
|
28 |
35/392 (8.93%)
|
39 |
Back pain |
34/401 (8.48%)
|
43 |
36/392 (9.18%)
|
43 |
Musculoskeletal pain |
17/401 (4.24%)
|
20 |
20/392 (5.10%)
|
22 |
Pain in extremity |
40/401 (9.98%)
|
51 |
32/392 (8.16%)
|
39 |
Nervous system disorders |
|
|
Dizziness |
36/401 (8.98%)
|
47 |
42/392 (10.71%)
|
56 |
Headache |
32/401 (7.98%)
|
44 |
38/392 (9.69%)
|
53 |
Psychiatric disorders |
|
|
Anxiety |
23/401 (5.74%)
|
23 |
22/392 (5.61%)
|
24 |
Depression |
14/401 (3.49%)
|
15 |
21/392 (5.36%)
|
21 |
Insomnia |
38/401 (9.48%)
|
52 |
45/392 (11.48%)
|
56 |
Renal and urinary disorders |
|
|
Acute kidney injury |
23/401 (5.74%)
|
24 |
16/392 (4.08%)
|
17 |
Respiratory, thoracic and mediastinal disorders |
|
|
Cough |
79/401 (19.70%)
|
100 |
66/392 (16.84%)
|
83 |
Dyspnea |
63/401 (15.71%)
|
83 |
51/392 (13.01%)
|
60 |
Epistaxis |
53/401 (13.22%)
|
71 |
36/392 (9.18%)
|
51 |
Oropharyngeal pain |
22/401 (5.49%)
|
29 |
23/392 (5.87%)
|
27 |
Pleural effusion |
21/401 (5.24%)
|
23 |
13/392 (3.32%)
|
13 |
Skin and subcutaneous tissue disorders |
|
|
Erythema |
21/401 (5.24%)
|
21 |
17/392 (4.34%)
|
20 |
Pruritis |
22/401 (5.49%)
|
28 |
26/392 (6.63%)
|
32 |
Rash |
41/401 (10.22%)
|
55 |
28/392 (7.14%)
|
33 |
Vascular disorders |
|
|
Hematoma |
25/401 (6.23%)
|
33 |
19/392 (4.85%)
|
29 |
Hypertension |
28/401 (6.98%)
|
42 |
25/392 (6.38%)
|
37 |
Hypotension |
31/401 (7.73%)
|
40 |
31/392 (7.91%)
|
37 |
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
|