Time Frame |
Up to 5 years
|
Adverse Event Reporting Description |
All participants are followed for survival (i.e. included in the All-cause mortality table). Participants who received at least one dose of treatment are evaluable for adverse events (i.e. included in the Serious AE and Other (Not Including Serious) AE tables).
|
|
Arm/Group Title
|
Arm A - R-CHOP
|
Arm B - DA-EPOCH-R
|
Arm/Group Description |
Cycles will be repeated every 21 da...
|
Cycles will be repeated every 21 da...
|
Arm/Group Description |
Cycles will be repeated every 21 days for 6 treatment cycles. Restaging will occur after Cycles 4 and 6.
|
Cycles will be repeated every 21 days for a maximum of 6 cycles. Restaging will occur after Cycles 4 and 6.
|
|
|
Arm A - R-CHOP
|
Arm B - DA-EPOCH-R
|
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Total |
53/250 (21.20%)
|
|
56/241 (23.24%)
|
|
|
|
Arm A - R-CHOP
|
Arm B - DA-EPOCH-R
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
232/243 (95.47%)
|
|
214/237 (90.30%)
|
|
Blood and lymphatic system disorders |
|
|
Febrile neutropenia |
23/243 (9.47%)
|
26 |
43/237 (18.14%)
|
64 |
Hemoglobin decreased |
193/243 (79.42%)
|
488 |
201/237 (84.81%)
|
564 |
Spleen disorder |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Cardiac disorders |
|
|
Atrial fibrillation |
0/243 (0.00%)
|
0 |
2/237 (0.84%)
|
2 |
Cardiac disorder |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Left ventricular failure |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Myocardial ischemia |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Palpitations |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Sinus bradycardia |
0/243 (0.00%)
|
0 |
2/237 (0.84%)
|
5 |
Sinus tachycardia |
1/243 (0.41%)
|
2 |
2/237 (0.84%)
|
2 |
Ear and labyrinth disorders |
|
|
Ear disorder |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Hearing impaired |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Eye disorders |
|
|
Extraocular muscle paresis |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Eye disorder |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Photophobia |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Vision blurred |
2/243 (0.82%)
|
2 |
3/237 (1.27%)
|
4 |
Gastrointestinal disorders |
|
|
Abdominal pain |
8/243 (3.29%)
|
8 |
11/237 (4.64%)
|
17 |
Anal mucositis (clin exam) |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Ascites |
1/243 (0.41%)
|
2 |
0/237 (0.00%)
|
0 |
Colonic hemorrhage |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
2 |
Constipation |
84/243 (34.57%)
|
128 |
81/237 (34.18%)
|
119 |
Diarrhea |
13/243 (5.35%)
|
19 |
14/237 (5.91%)
|
14 |
Dry mouth |
3/243 (1.23%)
|
3 |
1/237 (0.42%)
|
1 |
Dyspepsia |
4/243 (1.65%)
|
4 |
4/237 (1.69%)
|
5 |
Esophageal mucositis (clin exam) |
2/243 (0.82%)
|
2 |
0/237 (0.00%)
|
0 |
Esophageal pain |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Gastritis |
1/243 (0.41%)
|
2 |
3/237 (1.27%)
|
7 |
Gastrointestinal disorder |
2/243 (0.82%)
|
2 |
0/237 (0.00%)
|
0 |
Hemorrhoids |
1/243 (0.41%)
|
1 |
2/237 (0.84%)
|
2 |
Ileus |
1/243 (0.41%)
|
1 |
2/237 (0.84%)
|
2 |
Mucositis oral (clin exam) |
13/243 (5.35%)
|
18 |
23/237 (9.70%)
|
28 |
Mucositis oral (funct/sympt) |
18/243 (7.41%)
|
31 |
32/237 (13.50%)
|
55 |
Nausea |
21/243 (8.64%)
|
33 |
15/237 (6.33%)
|
25 |
Oral hemorrhage |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Oral pain |
0/243 (0.00%)
|
0 |
3/237 (1.27%)
|
3 |
Periodontal disease |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Rectal hemorrhage |
0/243 (0.00%)
|
0 |
3/237 (1.27%)
|
3 |
Rectal pain |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Stomach pain |
1/243 (0.41%)
|
1 |
1/237 (0.42%)
|
1 |
Tooth disorder |
1/243 (0.41%)
|
1 |
1/237 (0.42%)
|
1 |
Toothache |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Vomiting |
8/243 (3.29%)
|
9 |
7/237 (2.95%)
|
9 |
General disorders |
|
|
Chest pain |
1/243 (0.41%)
|
1 |
2/237 (0.84%)
|
2 |
Chills |
2/243 (0.82%)
|
2 |
3/237 (1.27%)
|
3 |
Death NOS |
3/243 (1.23%)
|
3 |
1/237 (0.42%)
|
1 |
Disease progression |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Edema limbs |
7/243 (2.88%)
|
9 |
9/237 (3.80%)
|
12 |
Fatigue |
27/243 (11.11%)
|
41 |
41/237 (17.30%)
|
60 |
Fever |
6/243 (2.47%)
|
6 |
2/237 (0.84%)
|
2 |
Gait abnormal |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
General symptom |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Localized edema |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Multi-organ failure |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Pain |
2/243 (0.82%)
|
2 |
2/237 (0.84%)
|
2 |
Sudden death |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Hepatobiliary disorders |
|
|
Gallbladder pain |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Immune system disorders |
|
|
Hypersensitivity |
15/243 (6.17%)
|
18 |
9/237 (3.80%)
|
9 |
Immune system disorder |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Infections and infestations |
|
|
Abdominal infection(gr 3/4 ANC) |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Anorectal infection(gr 3/4 ANC) |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Bladder infection(gr 0/1/2 ANC) |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Bladder infection(gr 3/4 ANC) |
0/243 (0.00%)
|
0 |
2/237 (0.84%)
|
3 |
Bronchitis(gr 0/1/2 ANC) |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Bronchitis(gr 3/4 ANC) |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Catheter related infection |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Catheter related infection(gr 3/4 ANC) |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Colitis, infectious |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Device related infection(gr 3/4 ANC) |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Esophageal infection(gr 0/1/2 ANC) |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Esophageal infection(gr 3/4 ANC) |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Gingival infection(gr 0/1/2 ANC) |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Gingival infection(gr 3/4 ANC) |
0/243 (0.00%)
|
0 |
3/237 (1.27%)
|
3 |
Infection(gr 0/1/2 ANC) |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Infectious colitis(gr 3/4 ANC) |
0/243 (0.00%)
|
0 |
2/237 (0.84%)
|
4 |
Nail infection(gr 0/1/2 ANC) |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Opportunistic infection |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Otitis externa(gr 3/4 ANC) |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Otitis media(gr 3/4 ANC) |
2/243 (0.82%)
|
2 |
0/237 (0.00%)
|
0 |
Paranasal sinus infection(gr 0/1/2 ANC) |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Pneumonia(gr 3/4 ANC) |
0/243 (0.00%)
|
0 |
3/237 (1.27%)
|
4 |
Pneumonia(unknown ANC) |
2/243 (0.82%)
|
2 |
1/237 (0.42%)
|
1 |
Rhinitis infective |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Sepsis(gr 3/4 ANC) |
1/243 (0.41%)
|
1 |
1/237 (0.42%)
|
1 |
Sepsis(unknown ANC) |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Sinusitis(gr 0/1/2 ANC) |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Sinusitis(gr 3/4 ANC) |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Skin infection |
1/243 (0.41%)
|
1 |
2/237 (0.84%)
|
2 |
Skin infection(gr 3/4 ANC) |
2/243 (0.82%)
|
2 |
1/237 (0.42%)
|
1 |
Tooth infection(gr 3/4 ANC) |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Upper respiratory infection(gr 3/4 ANC) |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Upper respiratory infectn(gr 0/1/2 ANC) |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Urinary tract infection(gr 0/1/2 ANC) |
1/243 (0.41%)
|
1 |
1/237 (0.42%)
|
2 |
Urinary tract infection(gr 3/4 ANC) |
1/243 (0.41%)
|
1 |
2/237 (0.84%)
|
3 |
Vaginal infection(gr 0/1/2 ANC) |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Wound infection |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Wound infection(gr 0/1/2 ANC) |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Injury, poisoning and procedural complications |
|
|
Bruising |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Fracture |
1/243 (0.41%)
|
1 |
2/237 (0.84%)
|
2 |
Thermal burn |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
2 |
Vascular access complication |
4/243 (1.65%)
|
4 |
4/237 (1.69%)
|
4 |
Wound dehiscence |
0/243 (0.00%)
|
0 |
2/237 (0.84%)
|
2 |
Investigations |
|
|
Activated partial throm time prolonged |
1/243 (0.41%)
|
2 |
1/237 (0.42%)
|
2 |
Alanine aminotransferase increased |
5/243 (2.06%)
|
6 |
7/237 (2.95%)
|
10 |
Alkaline phosphatase increased |
0/243 (0.00%)
|
0 |
6/237 (2.53%)
|
18 |
Aspartate aminotransferase increased |
8/243 (3.29%)
|
10 |
5/237 (2.11%)
|
6 |
Blood bilirubin increased |
1/243 (0.41%)
|
1 |
4/237 (1.69%)
|
7 |
CD4 lymphocytes decreased |
1/243 (0.41%)
|
4 |
2/237 (0.84%)
|
3 |
Creatinine increased |
3/243 (1.23%)
|
6 |
5/237 (2.11%)
|
8 |
Gamma-glutamyltransferase increased |
0/243 (0.00%)
|
0 |
4/237 (1.69%)
|
7 |
INR increased |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
2 |
Laboratory test abnormal |
2/243 (0.82%)
|
3 |
2/237 (0.84%)
|
2 |
Leukocyte count decreased |
72/243 (29.63%)
|
117 |
105/237 (44.30%)
|
242 |
Lymphocyte count decreased |
60/243 (24.69%)
|
114 |
86/237 (36.29%)
|
231 |
Neutrophil count decreased |
179/243 (73.66%)
|
331 |
190/237 (80.17%)
|
506 |
Platelet count decreased |
97/243 (39.92%)
|
182 |
184/237 (77.64%)
|
479 |
Serum cholesterol increased |
1/243 (0.41%)
|
3 |
0/237 (0.00%)
|
0 |
Weight loss |
4/243 (1.65%)
|
5 |
1/237 (0.42%)
|
1 |
Metabolism and nutrition disorders |
|
|
Anorexia |
8/243 (3.29%)
|
9 |
14/237 (5.91%)
|
17 |
Blood glucose increased |
20/243 (8.23%)
|
37 |
25/237 (10.55%)
|
39 |
Blood uric acid increased |
1/243 (0.41%)
|
3 |
2/237 (0.84%)
|
2 |
Dehydration |
22/243 (9.05%)
|
24 |
19/237 (8.02%)
|
22 |
Glucose intolerance |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Serum albumin decreased |
3/243 (1.23%)
|
4 |
12/237 (5.06%)
|
19 |
Serum calcium decreased |
4/243 (1.65%)
|
4 |
15/237 (6.33%)
|
28 |
Serum calcium increased |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Serum glucose decreased |
0/243 (0.00%)
|
0 |
5/237 (2.11%)
|
10 |
Serum magnesium decreased |
4/243 (1.65%)
|
4 |
4/237 (1.69%)
|
4 |
Serum magnesium increased |
0/243 (0.00%)
|
0 |
5/237 (2.11%)
|
11 |
Serum phosphate decreased |
5/243 (2.06%)
|
5 |
12/237 (5.06%)
|
14 |
Serum potassium decreased |
5/243 (2.06%)
|
6 |
29/237 (12.24%)
|
44 |
Serum potassium increased |
2/243 (0.82%)
|
3 |
1/237 (0.42%)
|
1 |
Serum sodium decreased |
5/243 (2.06%)
|
5 |
6/237 (2.53%)
|
7 |
Serum sodium increased |
0/243 (0.00%)
|
0 |
3/237 (1.27%)
|
5 |
Serum triglycerides increased |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Tumor lysis syndrome |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Musculoskeletal and connective tissue disorders |
|
|
Arthralgia |
5/243 (2.06%)
|
5 |
8/237 (3.38%)
|
9 |
Arthritis |
1/243 (0.41%)
|
1 |
1/237 (0.42%)
|
1 |
Back pain |
6/243 (2.47%)
|
7 |
5/237 (2.11%)
|
5 |
Bone pain |
4/243 (1.65%)
|
5 |
17/237 (7.17%)
|
28 |
Chest wall pain |
0/243 (0.00%)
|
0 |
3/237 (1.27%)
|
3 |
Muscle weakness |
1/243 (0.41%)
|
2 |
5/237 (2.11%)
|
6 |
Muscle weakness lower limb |
2/243 (0.82%)
|
2 |
2/237 (0.84%)
|
2 |
Musculoskeletal disorder |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Myalgia |
6/243 (2.47%)
|
8 |
3/237 (1.27%)
|
5 |
Myositis |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Neck pain |
1/243 (0.41%)
|
1 |
2/237 (0.84%)
|
2 |
Pain in extremity |
6/243 (2.47%)
|
7 |
3/237 (1.27%)
|
4 |
Nervous system disorders |
|
|
Arachnoiditis |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Ataxia |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Cognitive disturbance |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Depressed level of consciousness |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Dizziness |
10/243 (4.12%)
|
11 |
8/237 (3.38%)
|
10 |
Dysgeusia |
4/243 (1.65%)
|
6 |
4/237 (1.69%)
|
7 |
Encephalopathy |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Extrapyramidal disorder |
1/243 (0.41%)
|
2 |
0/237 (0.00%)
|
0 |
Headache |
6/243 (2.47%)
|
8 |
14/237 (5.91%)
|
15 |
Intracranial hemorrhage |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Neuralgia |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Neurological disorder NOS |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Peripheral motor neuropathy |
23/243 (9.47%)
|
31 |
36/237 (15.19%)
|
62 |
Peripheral sensory neuropathy |
104/243 (42.80%)
|
186 |
141/237 (59.49%)
|
322 |
Syncope |
2/243 (0.82%)
|
2 |
2/237 (0.84%)
|
2 |
Tremor |
2/243 (0.82%)
|
2 |
1/237 (0.42%)
|
1 |
Psychiatric disorders |
|
|
Agitation |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Anxiety |
2/243 (0.82%)
|
4 |
5/237 (2.11%)
|
7 |
Confusion |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Depression |
5/243 (2.06%)
|
8 |
7/237 (2.95%)
|
9 |
Insomnia |
8/243 (3.29%)
|
11 |
5/237 (2.11%)
|
6 |
Libido decreased |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
2 |
Psychosis |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Renal and urinary disorders |
|
|
Cystitis |
1/243 (0.41%)
|
1 |
1/237 (0.42%)
|
1 |
Kidney pain |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Renal failure |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Urinary frequency |
2/243 (0.82%)
|
2 |
1/237 (0.42%)
|
1 |
Urinary retention |
0/243 (0.00%)
|
0 |
2/237 (0.84%)
|
2 |
Reproductive system and breast disorders |
|
|
Erectile dysfunction |
1/243 (0.41%)
|
1 |
1/237 (0.42%)
|
2 |
Gynecomastia |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Pelvic pain |
1/243 (0.41%)
|
2 |
0/237 (0.00%)
|
0 |
Testicular hemorrhage |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Vaginal hemorrhage |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Respiratory, thoracic and mediastinal disorders |
|
|
Allergic rhinitis |
3/243 (1.23%)
|
3 |
4/237 (1.69%)
|
6 |
Cough |
6/243 (2.47%)
|
7 |
9/237 (3.80%)
|
12 |
Dyspnea |
4/243 (1.65%)
|
4 |
11/237 (4.64%)
|
17 |
Nasal congestion |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Pharyngeal mucositis (funct/sympt) |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
2 |
Pharyngeal stenosis |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Pharyngolaryngeal pain |
3/243 (1.23%)
|
3 |
1/237 (0.42%)
|
2 |
Pleural effusion |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Pneumonitis |
2/243 (0.82%)
|
3 |
0/237 (0.00%)
|
0 |
Respiratory disorder |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Voice alteration |
0/243 (0.00%)
|
0 |
2/237 (0.84%)
|
2 |
Skin and subcutaneous tissue disorders |
|
|
Alopecia |
13/243 (5.35%)
|
23 |
8/237 (3.38%)
|
19 |
Body odor |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Decubitus ulcer |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Dry skin |
0/243 (0.00%)
|
0 |
2/237 (0.84%)
|
2 |
Hand-and-foot syndrome/reaction |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Nail disorder |
0/243 (0.00%)
|
0 |
4/237 (1.69%)
|
4 |
Pruritus |
1/243 (0.41%)
|
1 |
2/237 (0.84%)
|
2 |
Rash desquamating |
3/243 (1.23%)
|
3 |
4/237 (1.69%)
|
4 |
Skin disorder |
2/243 (0.82%)
|
2 |
1/237 (0.42%)
|
2 |
Skin hyperpigmentation |
1/243 (0.41%)
|
1 |
2/237 (0.84%)
|
4 |
Skin ulceration |
1/243 (0.41%)
|
1 |
1/237 (0.42%)
|
1 |
Sweating |
6/243 (2.47%)
|
8 |
0/237 (0.00%)
|
0 |
Vascular disorders |
|
|
Flushing |
0/243 (0.00%)
|
0 |
2/237 (0.84%)
|
2 |
Hemorrhage |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Hot flashes |
1/243 (0.41%)
|
2 |
0/237 (0.00%)
|
0 |
Hypertension |
2/243 (0.82%)
|
4 |
9/237 (3.80%)
|
12 |
Hypotension |
0/243 (0.00%)
|
0 |
7/237 (2.95%)
|
11 |
Thrombosis |
6/243 (2.47%)
|
6 |
4/237 (1.69%)
|
5 |
Vascular disorder |
2/243 (0.82%)
|
2 |
0/237 (0.00%)
|
0 |
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
|
|
Frequency Threshold for Reporting Other Adverse Events
|
0%
|
|
Arm A - R-CHOP
|
Arm B - DA-EPOCH-R
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
94/243 (38.68%)
|
|
119/237 (50.21%)
|
|
Blood and lymphatic system disorders |
|
|
Blood disorder |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Febrile neutropenia |
26/243 (10.70%)
|
27 |
44/237 (18.57%)
|
57 |
Hemoglobin decreased |
80/243 (32.92%)
|
126 |
116/237 (48.95%)
|
199 |
Lymphatic disorder |
1/243 (0.41%)
|
1 |
1/237 (0.42%)
|
1 |
Cardiac disorders |
|
|
Asystole |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Atrial fibrillation |
4/243 (1.65%)
|
5 |
6/237 (2.53%)
|
7 |
Atrial flutter |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Atrial tachycardia |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Cardiac disorder |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Cardiopulmonary arrest |
1/243 (0.41%)
|
1 |
1/237 (0.42%)
|
1 |
Left ventricular dysfunction |
2/243 (0.82%)
|
2 |
0/237 (0.00%)
|
0 |
Left ventricular failure |
6/243 (2.47%)
|
6 |
3/237 (1.27%)
|
3 |
Myocardial ischemia |
2/243 (0.82%)
|
2 |
0/237 (0.00%)
|
0 |
Sinus bradycardia |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Sinus tachycardia |
1/243 (0.41%)
|
1 |
7/237 (2.95%)
|
7 |
Ear and labyrinth disorders |
|
|
Ear pain |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Hearing impaired |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Endocrine disorders |
|
|
Adrenal insufficiency |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Gastrointestinal disorders |
|
|
Abdominal pain |
10/243 (4.12%)
|
11 |
8/237 (3.38%)
|
9 |
Ascites |
2/243 (0.82%)
|
2 |
1/237 (0.42%)
|
1 |
Colitis |
1/243 (0.41%)
|
2 |
1/237 (0.42%)
|
1 |
Colonic hemorrhage |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
2 |
Constipation |
18/243 (7.41%)
|
20 |
35/237 (14.77%)
|
45 |
Diarrhea |
8/243 (3.29%)
|
9 |
14/237 (5.91%)
|
15 |
Duodenal hemorrhage |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Duodenal stenosis |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Dyspepsia |
2/243 (0.82%)
|
2 |
1/237 (0.42%)
|
1 |
Dysphagia |
1/243 (0.41%)
|
1 |
7/237 (2.95%)
|
7 |
Esophagitis |
0/243 (0.00%)
|
0 |
2/237 (0.84%)
|
3 |
Fecal incontinence |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Gastric hemorrhage |
1/243 (0.41%)
|
1 |
2/237 (0.84%)
|
2 |
Gastric perforation |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Gastritis |
1/243 (0.41%)
|
1 |
1/237 (0.42%)
|
1 |
Ileal perforation |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Ileus |
4/243 (1.65%)
|
4 |
5/237 (2.11%)
|
6 |
Jejunal obstruction |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Lower gastrointestinal hemorrhage |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Malabsorption |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Mucositis oral (clin exam) |
3/243 (1.23%)
|
4 |
13/237 (5.49%)
|
19 |
Mucositis oral (funct/sympt) |
5/243 (2.06%)
|
5 |
17/237 (7.17%)
|
21 |
Nausea |
9/243 (3.70%)
|
9 |
13/237 (5.49%)
|
15 |
Oral pain |
0/243 (0.00%)
|
0 |
3/237 (1.27%)
|
3 |
Periodontal disease |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Small intestinal obstruction |
1/243 (0.41%)
|
1 |
1/237 (0.42%)
|
1 |
Small intestinal perforation |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Small intestinal stenosis |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Upper gastrointestinal hemorrhage |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Vomiting |
6/243 (2.47%)
|
6 |
11/237 (4.64%)
|
12 |
General disorders |
|
|
Chest pain |
1/243 (0.41%)
|
1 |
4/237 (1.69%)
|
4 |
Chills |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Edema limbs |
10/243 (4.12%)
|
11 |
6/237 (2.53%)
|
6 |
Fatigue |
14/243 (5.76%)
|
17 |
20/237 (8.44%)
|
23 |
Fever |
3/243 (1.23%)
|
3 |
2/237 (0.84%)
|
2 |
Hypothermia |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Ill-defined disorder |
1/243 (0.41%)
|
1 |
1/237 (0.42%)
|
1 |
Pain |
0/243 (0.00%)
|
0 |
3/237 (1.27%)
|
3 |
Visceral edema |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Hepatobiliary disorders |
|
|
Gallbladder obstruction |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Gallbladder pain |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Immune system disorders |
|
|
Cytokine release syndrome |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Hypersensitivity |
2/243 (0.82%)
|
2 |
5/237 (2.11%)
|
5 |
Immune system disorder |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Infections and infestations |
|
|
Abdominal infection |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Abdominal infection(unknown ANC) |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Anorectal infection(gr 0/1/2 ANC) |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Appendicitis perforated |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Bladder infection(gr 0/1/2 ANC) |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Bladder infection(gr 3/4 ANC) |
0/243 (0.00%)
|
0 |
2/237 (0.84%)
|
2 |
Bronchitis(gr 3/4 ANC) |
1/243 (0.41%)
|
1 |
1/237 (0.42%)
|
1 |
Catheter related infection |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Catheter related infection(gr 0/1/2 ANC) |
2/243 (0.82%)
|
2 |
1/237 (0.42%)
|
1 |
Catheter related infection(gr 3/4 ANC) |
4/243 (1.65%)
|
4 |
4/237 (1.69%)
|
4 |
Colitis, infectious |
1/243 (0.41%)
|
1 |
2/237 (0.84%)
|
3 |
Esophageal infection(unknown ANC) |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Gingival infection(gr 3/4 ANC) |
0/243 (0.00%)
|
0 |
2/237 (0.84%)
|
2 |
Infection(gr 0/1/2 ANC) |
2/243 (0.82%)
|
3 |
6/237 (2.53%)
|
6 |
Infectious colitis(gr 0/1/2 ANC) |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Infectious colitis(gr 3/4 ANC) |
0/243 (0.00%)
|
0 |
2/237 (0.84%)
|
3 |
Lip infection(gr 3/4 ANC) |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Lymph gland infection(gr 3/4 ANC) |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Mucosal infection(gr 3/4 ANC) |
0/243 (0.00%)
|
0 |
2/237 (0.84%)
|
2 |
Opportunistic infection |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Pancreas infection(gr 3/4 ANC) |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Peritoneal infection(gr 3/4 ANC) |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Pneumonia(gr 0/1/2 ANC) |
3/243 (1.23%)
|
3 |
0/237 (0.00%)
|
0 |
Pneumonia(gr 3/4 ANC) |
4/243 (1.65%)
|
4 |
5/237 (2.11%)
|
5 |
Pneumonia(unknown ANC) |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Sepsis(gr 0/1/2 ANC) |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Sepsis(gr 3/4 ANC) |
2/243 (0.82%)
|
2 |
3/237 (1.27%)
|
4 |
Sepsis(unknown ANC) |
0/243 (0.00%)
|
0 |
3/237 (1.27%)
|
3 |
Skin infection |
1/243 (0.41%)
|
1 |
1/237 (0.42%)
|
1 |
Skin infection(gr 3/4 ANC) |
2/243 (0.82%)
|
2 |
1/237 (0.42%)
|
1 |
Tooth infection(gr 3/4 ANC) |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Upper respiratory infection(gr 3/4 ANC) |
3/243 (1.23%)
|
3 |
0/237 (0.00%)
|
0 |
Upper respiratory infectn(gr 0/1/2 ANC) |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Urinary tract infection(gr 0/1/2 ANC) |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Urinary tract infection(gr 3/4 ANC) |
3/243 (1.23%)
|
3 |
5/237 (2.11%)
|
6 |
Vaginal infection(gr 0/1/2 ANC) |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Vaginal infection(gr 3/4 ANC) |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Wound infection |
0/243 (0.00%)
|
0 |
2/237 (0.84%)
|
2 |
Wound infection(gr 0/1/2 ANC) |
1/243 (0.41%)
|
1 |
1/237 (0.42%)
|
1 |
Wound infection(gr 3/4 ANC) |
2/243 (0.82%)
|
2 |
1/237 (0.42%)
|
1 |
Injury, poisoning and procedural complications |
|
|
Bruising |
0/243 (0.00%)
|
0 |
2/237 (0.84%)
|
2 |
Fracture |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Intraop. inj. - Spinal cord |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Thermal burn |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Vascular access complication |
1/243 (0.41%)
|
1 |
3/237 (1.27%)
|
4 |
Venous injury - Viscera |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Wound dehiscence |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Investigations |
|
|
Activated partial throm time prolonged |
0/243 (0.00%)
|
0 |
4/237 (1.69%)
|
4 |
Alanine aminotransferase increased |
3/243 (1.23%)
|
3 |
6/237 (2.53%)
|
6 |
Alkaline phosphatase increased |
2/243 (0.82%)
|
2 |
5/237 (2.11%)
|
5 |
Aspartate aminotransferase increased |
3/243 (1.23%)
|
3 |
4/237 (1.69%)
|
4 |
Blood bilirubin increased |
4/243 (1.65%)
|
4 |
4/237 (1.69%)
|
5 |
CD4 lymphocytes decreased |
1/243 (0.41%)
|
1 |
2/237 (0.84%)
|
3 |
Cardiac troponin T increased |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Creatine phosphokinase increased |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Creatinine increased |
1/243 (0.41%)
|
2 |
3/237 (1.27%)
|
3 |
Leukocyte count decreased |
42/243 (17.28%)
|
58 |
66/237 (27.85%)
|
106 |
Lipase increased |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Lymphocyte count decreased |
34/243 (13.99%)
|
52 |
51/237 (21.52%)
|
93 |
Neutrophil count decreased |
74/243 (30.45%)
|
109 |
107/237 (45.15%)
|
169 |
Platelet count decreased |
53/243 (21.81%)
|
73 |
107/237 (45.15%)
|
167 |
Serum cholesterol increased |
1/243 (0.41%)
|
1 |
4/237 (1.69%)
|
6 |
Weight loss |
4/243 (1.65%)
|
4 |
4/237 (1.69%)
|
4 |
Metabolism and nutrition disorders |
|
|
Acidosis |
1/243 (0.41%)
|
1 |
1/237 (0.42%)
|
1 |
Alkalosis |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Anorexia |
7/243 (2.88%)
|
7 |
5/237 (2.11%)
|
6 |
Blood glucose increased |
12/243 (4.94%)
|
13 |
13/237 (5.49%)
|
18 |
Blood uric acid increased |
2/243 (0.82%)
|
2 |
3/237 (1.27%)
|
5 |
Dehydration |
16/243 (6.58%)
|
18 |
21/237 (8.86%)
|
28 |
Serum albumin decreased |
8/243 (3.29%)
|
10 |
19/237 (8.02%)
|
23 |
Serum calcium decreased |
7/243 (2.88%)
|
8 |
16/237 (6.75%)
|
20 |
Serum calcium increased |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Serum glucose decreased |
1/243 (0.41%)
|
1 |
3/237 (1.27%)
|
3 |
Serum magnesium decreased |
1/243 (0.41%)
|
1 |
4/237 (1.69%)
|
4 |
Serum magnesium increased |
1/243 (0.41%)
|
1 |
4/237 (1.69%)
|
4 |
Serum phosphate decreased |
5/243 (2.06%)
|
6 |
11/237 (4.64%)
|
14 |
Serum potassium decreased |
5/243 (2.06%)
|
5 |
23/237 (9.70%)
|
28 |
Serum potassium increased |
2/243 (0.82%)
|
2 |
2/237 (0.84%)
|
2 |
Serum sodium decreased |
8/243 (3.29%)
|
8 |
10/237 (4.22%)
|
13 |
Serum sodium increased |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Serum triglycerides increased |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
2 |
Tumor lysis syndrome |
2/243 (0.82%)
|
2 |
1/237 (0.42%)
|
1 |
Musculoskeletal and connective tissue disorders |
|
|
Arthralgia |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Back pain |
3/243 (1.23%)
|
3 |
2/237 (0.84%)
|
2 |
Bone pain |
1/243 (0.41%)
|
1 |
5/237 (2.11%)
|
5 |
Muscle weakness |
3/243 (1.23%)
|
3 |
8/237 (3.38%)
|
10 |
Muscle weakness lower limb |
1/243 (0.41%)
|
1 |
1/237 (0.42%)
|
1 |
Muscle weakness right-sided |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Musculoskeletal disorder |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Myalgia |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Neck pain |
0/243 (0.00%)
|
0 |
2/237 (0.84%)
|
2 |
Neck soft tissue necrosis |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
2 |
Pain in extremity |
1/243 (0.41%)
|
1 |
3/237 (1.27%)
|
3 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
Tumor pain |
1/243 (0.41%)
|
1 |
1/237 (0.42%)
|
1 |
Nervous system disorders |
|
|
Cognitive disturbance |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Depressed level of consciousness |
1/243 (0.41%)
|
1 |
1/237 (0.42%)
|
1 |
Dizziness |
5/243 (2.06%)
|
6 |
2/237 (0.84%)
|
2 |
Dysgeusia |
2/243 (0.82%)
|
2 |
1/237 (0.42%)
|
1 |
Encephalopathy |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Headache |
2/243 (0.82%)
|
2 |
2/237 (0.84%)
|
2 |
Ischemia cerebrovascular |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Mini mental status examination abnormal |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Neurological disorder NOS |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Peripheral motor neuropathy |
5/243 (2.06%)
|
5 |
16/237 (6.75%)
|
20 |
Peripheral sensory neuropathy |
25/243 (10.29%)
|
31 |
68/237 (28.69%)
|
108 |
Seizure |
0/243 (0.00%)
|
0 |
3/237 (1.27%)
|
3 |
Syncope |
0/243 (0.00%)
|
0 |
3/237 (1.27%)
|
3 |
Psychiatric disorders |
|
|
Anxiety |
0/243 (0.00%)
|
0 |
3/237 (1.27%)
|
3 |
Confusion |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Depression |
0/243 (0.00%)
|
0 |
4/237 (1.69%)
|
4 |
Insomnia |
3/243 (1.23%)
|
3 |
4/237 (1.69%)
|
4 |
Renal and urinary disorders |
|
|
Bladder pain |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Bladder spasm |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Cystitis |
1/243 (0.41%)
|
1 |
1/237 (0.42%)
|
1 |
Hemorrhage urinary tract |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Kidney pain |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Proteinuria |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Renal failure |
4/243 (1.65%)
|
4 |
5/237 (2.11%)
|
5 |
Urinary frequency |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Urinary retention |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Urogenital disorder |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Reproductive system and breast disorders |
|
|
Pelvic pain |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Respiratory, thoracic and mediastinal disorders |
|
|
Adult respiratory distress syndrome |
2/243 (0.82%)
|
2 |
0/237 (0.00%)
|
0 |
Allergic rhinitis |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Atelectasis |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Cough |
2/243 (0.82%)
|
2 |
4/237 (1.69%)
|
4 |
Dyspnea |
8/243 (3.29%)
|
10 |
9/237 (3.80%)
|
10 |
Hiccups |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Hypoxia |
4/243 (1.65%)
|
4 |
8/237 (3.38%)
|
9 |
Pharyngeal mucositis (clin exam) |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Pharyngolaryngeal pain |
1/243 (0.41%)
|
1 |
2/237 (0.84%)
|
2 |
Pleural effusion |
2/243 (0.82%)
|
2 |
2/237 (0.84%)
|
2 |
Pneumonitis |
4/243 (1.65%)
|
4 |
3/237 (1.27%)
|
3 |
Pneumothorax |
1/243 (0.41%)
|
1 |
0/237 (0.00%)
|
0 |
Respiratory disorder |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Voice alteration |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Skin and subcutaneous tissue disorders |
|
|
Alopecia |
4/243 (1.65%)
|
4 |
6/237 (2.53%)
|
6 |
Decubitus ulcer |
1/243 (0.41%)
|
1 |
1/237 (0.42%)
|
1 |
Erythema multiforme |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Nail disorder |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Pruritus |
0/243 (0.00%)
|
0 |
2/237 (0.84%)
|
2 |
Rash acneiform |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Rash desquamating |
1/243 (0.41%)
|
1 |
1/237 (0.42%)
|
1 |
Skin ulceration |
2/243 (0.82%)
|
2 |
0/237 (0.00%)
|
0 |
Sweating |
1/243 (0.41%)
|
1 |
1/237 (0.42%)
|
1 |
Vascular disorders |
|
|
Flushing |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Hemorrhage |
0/243 (0.00%)
|
0 |
1/237 (0.42%)
|
1 |
Hypertension |
1/243 (0.41%)
|
1 |
2/237 (0.84%)
|
2 |
Hypotension |
8/243 (3.29%)
|
8 |
13/237 (5.49%)
|
15 |
Thrombosis |
6/243 (2.47%)
|
6 |
10/237 (4.22%)
|
11 |
Vascular disorder |
1/243 (0.41%)
|
1 |
1/237 (0.42%)
|
1 |
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
|