Time Frame |
[Not Specified]
|
Adverse Event Reporting Description |
709 participants were evaluated for adverse events.
|
|
Arm/Group Title
|
Induction and Consolidation Chemotherapy Plus Midostaurin
|
Induction and Consolidation Chemotherapy Plus Placebo
|
Arm/Group Description |
Patients will receive daunorubicin ...
|
Patients will receive daunorubicin ...
|
Arm/Group Description |
Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
|
Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
|
|
|
Induction and Consolidation Chemotherapy Plus Midostaurin
|
Induction and Consolidation Chemotherapy Plus Placebo
|
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Total |
--/--
|
|
--/--
|
|
|
|
Induction and Consolidation Chemotherapy Plus Midostaurin
|
Induction and Consolidation Chemotherapy Plus Placebo
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
157/355 (44.23%)
|
|
154/354 (43.50%)
|
|
Blood and lymphatic system disorders |
|
|
Blood disorder |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Bone marrow hypocellular |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Disseminated intravascular coagulation |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Febrile neutropenia |
105/355 (29.58%)
|
144 |
110/354 (31.07%)
|
152 |
Hemoglobin decreased |
154/355 (43.38%)
|
237 |
148/354 (41.81%)
|
230 |
Hemolysis |
2/355 (0.56%)
|
2 |
0/354 (0.00%)
|
0 |
Lymph node pain |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Lymphatic disorder |
6/355 (1.69%)
|
6 |
4/354 (1.13%)
|
4 |
Cardiac disorders |
|
|
Arrhythmia |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
2 |
Asystole |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Atrial fibrillation |
4/355 (1.13%)
|
4 |
6/354 (1.69%)
|
6 |
Atrial flutter |
2/355 (0.56%)
|
2 |
2/354 (0.56%)
|
2 |
Atrial tachycardia |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
2 |
Cardiac disorder |
4/355 (1.13%)
|
4 |
6/354 (1.69%)
|
6 |
Cardiac pain |
3/355 (0.85%)
|
3 |
1/354 (0.28%)
|
1 |
Cardiopulmonary arrest |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Conduction disorder |
0/355 (0.00%)
|
0 |
2/354 (0.56%)
|
2 |
Left ventricular dysfunction |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Left ventricular failure |
8/355 (2.25%)
|
9 |
7/354 (1.98%)
|
7 |
Myocardial ischemia |
3/355 (0.85%)
|
3 |
3/354 (0.85%)
|
3 |
Palpitations |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Pericardial effusion |
4/355 (1.13%)
|
4 |
5/354 (1.41%)
|
5 |
Pericarditis |
3/355 (0.85%)
|
3 |
0/354 (0.00%)
|
0 |
Right ventricular dysfunction |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Sinus arrhythmia |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Sinus bradycardia |
2/355 (0.56%)
|
2 |
2/354 (0.56%)
|
2 |
Sinus tachycardia |
17/355 (4.79%)
|
20 |
15/354 (4.24%)
|
20 |
Supraventricular tachycardia |
0/355 (0.00%)
|
0 |
2/354 (0.56%)
|
2 |
Ventricular fibrillation |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Ventricular tachycardia |
0/355 (0.00%)
|
0 |
3/354 (0.85%)
|
3 |
Ear and labyrinth disorders |
|
|
Ear disorder |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
2 |
Ear pain |
2/355 (0.56%)
|
2 |
3/354 (0.85%)
|
3 |
External ear pain |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Middle ear inflammation |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Tinnitus |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Endocrine disorders |
|
|
Endocrine disorder |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Hyperthyroidism |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Hypothyroidism |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Eye disorders |
|
|
Cataract |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Conjunctivitis |
2/355 (0.56%)
|
2 |
1/354 (0.28%)
|
1 |
Diplopia |
1/355 (0.28%)
|
1 |
1/354 (0.28%)
|
1 |
Dry eye syndrome |
3/355 (0.85%)
|
3 |
3/354 (0.85%)
|
3 |
Eye disorder |
8/355 (2.25%)
|
9 |
12/354 (3.39%)
|
12 |
Eye pain |
1/355 (0.28%)
|
1 |
1/354 (0.28%)
|
1 |
Eyelid function disorder |
0/355 (0.00%)
|
0 |
2/354 (0.56%)
|
2 |
Flashing vision |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
2 |
Keratitis |
5/355 (1.41%)
|
6 |
8/354 (2.26%)
|
9 |
Optic nerve edema |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Photophobia |
2/355 (0.56%)
|
2 |
1/354 (0.28%)
|
1 |
Retinal detachment |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Scleral disorder |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Vision blurred |
2/355 (0.56%)
|
2 |
4/354 (1.13%)
|
4 |
Watering eyes |
2/355 (0.56%)
|
2 |
3/354 (0.85%)
|
3 |
Gastrointestinal disorders |
|
|
Abdominal distension |
4/355 (1.13%)
|
4 |
2/354 (0.56%)
|
2 |
Abdominal pain |
29/355 (8.17%)
|
33 |
28/354 (7.91%)
|
32 |
Anal fistula |
1/355 (0.28%)
|
1 |
1/354 (0.28%)
|
1 |
Anal hemorrhage |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
2 |
Anal mucositis |
2/355 (0.56%)
|
2 |
0/354 (0.00%)
|
0 |
Anal pain |
7/355 (1.97%)
|
8 |
5/354 (1.41%)
|
5 |
Anal ulcer |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Ascites |
2/355 (0.56%)
|
2 |
2/354 (0.56%)
|
2 |
Colitis |
9/355 (2.54%)
|
9 |
9/354 (2.54%)
|
9 |
Colonic hemorrhage |
2/355 (0.56%)
|
2 |
0/354 (0.00%)
|
0 |
Colonic perforation |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Constipation |
16/355 (4.51%)
|
18 |
17/354 (4.80%)
|
18 |
Diarrhea |
89/355 (25.07%)
|
111 |
89/354 (25.14%)
|
108 |
Dry mouth |
2/355 (0.56%)
|
2 |
1/354 (0.28%)
|
1 |
Duodenal hemorrhage |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Duodenal necrosis |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Dyspepsia |
10/355 (2.82%)
|
11 |
8/354 (2.26%)
|
8 |
Dysphagia |
10/355 (2.82%)
|
10 |
10/354 (2.82%)
|
12 |
Ear, nose and throat examination abnormal |
40/355 (11.27%)
|
52 |
42/354 (11.86%)
|
54 |
Endoscopy small intestine abnormal |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Enteritis |
2/355 (0.56%)
|
2 |
1/354 (0.28%)
|
1 |
Esophageal pain |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
2 |
Esophageal ulcer |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Esophagitis |
0/355 (0.00%)
|
0 |
2/354 (0.56%)
|
2 |
Flatulence |
7/355 (1.97%)
|
8 |
5/354 (1.41%)
|
6 |
Gastric hemorrhage |
2/355 (0.56%)
|
2 |
1/354 (0.28%)
|
1 |
Gastrointestinal disorder |
10/355 (2.82%)
|
12 |
10/354 (2.82%)
|
10 |
Gastrointestinal pain |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Gingival pain |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
2 |
Hemorrhoidal hemorrhage |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Hemorrhoids |
11/355 (3.10%)
|
14 |
7/354 (1.98%)
|
7 |
Ileal hemorrhage |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Ileal necrosis |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Ileus |
2/355 (0.56%)
|
2 |
4/354 (1.13%)
|
4 |
Intestinal necrosis |
2/355 (0.56%)
|
2 |
0/354 (0.00%)
|
0 |
Intra-abdominal hemorrhage |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Jejunal necrosis |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Lower gastrointestinal hemorrhage |
2/355 (0.56%)
|
2 |
3/354 (0.85%)
|
3 |
Mucositis oral |
23/355 (6.48%)
|
23 |
11/354 (3.11%)
|
13 |
Nausea |
98/355 (27.61%)
|
149 |
91/354 (25.71%)
|
126 |
Oral hemorrhage |
5/355 (1.41%)
|
6 |
10/354 (2.82%)
|
11 |
Oral pain |
5/355 (1.41%)
|
5 |
5/354 (1.41%)
|
6 |
Periodontal disease |
2/355 (0.56%)
|
2 |
1/354 (0.28%)
|
1 |
Proctitis |
1/355 (0.28%)
|
1 |
1/354 (0.28%)
|
1 |
Rectal hemorrhage |
3/355 (0.85%)
|
3 |
3/354 (0.85%)
|
3 |
Rectal obstruction |
2/355 (0.56%)
|
2 |
0/354 (0.00%)
|
0 |
Rectal pain |
2/355 (0.56%)
|
2 |
1/354 (0.28%)
|
1 |
Salivary gland disorder |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
2 |
Stomach pain |
8/355 (2.25%)
|
12 |
9/354 (2.54%)
|
9 |
Tooth disorder |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
2 |
Toothache |
3/355 (0.85%)
|
3 |
4/354 (1.13%)
|
4 |
Typhlitis |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
2 |
Upper gastrointestinal hemorrhage |
2/355 (0.56%)
|
2 |
1/354 (0.28%)
|
1 |
Vomiting |
70/355 (19.72%)
|
101 |
65/354 (18.36%)
|
86 |
General disorders |
|
|
Chest pain |
6/355 (1.69%)
|
7 |
11/354 (3.11%)
|
12 |
Chills |
16/355 (4.51%)
|
21 |
16/354 (4.52%)
|
24 |
Disease progression |
1/355 (0.28%)
|
1 |
1/354 (0.28%)
|
1 |
Edema limbs |
26/355 (7.32%)
|
32 |
21/354 (5.93%)
|
24 |
Facial pain |
2/355 (0.56%)
|
2 |
2/354 (0.56%)
|
2 |
Fatigue |
95/355 (26.76%)
|
136 |
98/354 (27.68%)
|
130 |
Fever |
34/355 (9.58%)
|
38 |
33/354 (9.32%)
|
38 |
Flu-like symptoms |
1/355 (0.28%)
|
1 |
1/354 (0.28%)
|
1 |
General symptom |
11/355 (3.10%)
|
14 |
15/354 (4.24%)
|
16 |
Ill-defined disorder |
1/355 (0.28%)
|
1 |
4/354 (1.13%)
|
4 |
Injection site reaction |
14/355 (3.94%)
|
17 |
17/354 (4.80%)
|
22 |
Localized edema |
5/355 (1.41%)
|
5 |
9/354 (2.54%)
|
11 |
Multi-organ failure |
4/355 (1.13%)
|
4 |
5/354 (1.41%)
|
5 |
Pain |
14/355 (3.94%)
|
17 |
18/354 (5.08%)
|
24 |
Sudden death |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Visceral edema |
1/355 (0.28%)
|
1 |
1/354 (0.28%)
|
1 |
Hepatobiliary disorders |
|
|
Cholecystitis |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
2 |
Hepatic failure |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
2 |
Hepatobiliary disease |
4/355 (1.13%)
|
4 |
1/354 (0.28%)
|
1 |
Immune system disorders |
|
|
Cytokine release syndrome |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Hypersensitivity |
7/355 (1.97%)
|
8 |
14/354 (3.95%)
|
15 |
Immune system disorder |
3/355 (0.85%)
|
3 |
3/354 (0.85%)
|
4 |
Infections and infestations |
|
|
Abdominal infection |
1/355 (0.28%)
|
1 |
3/354 (0.85%)
|
3 |
Anal infection |
6/355 (1.69%)
|
9 |
5/354 (1.41%)
|
5 |
Anorectal infection |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Appendicitis |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Bladder infection |
2/355 (0.56%)
|
2 |
3/354 (0.85%)
|
3 |
Bone infection |
1/355 (0.28%)
|
1 |
1/354 (0.28%)
|
1 |
Bronchitis |
1/355 (0.28%)
|
1 |
3/354 (0.85%)
|
4 |
Catheter related infection |
29/355 (8.17%)
|
39 |
21/354 (5.93%)
|
26 |
Colitis, infectious (e.g., Clostridium difficile) |
3/355 (0.85%)
|
3 |
2/354 (0.56%)
|
2 |
Conjunctivitis infective |
4/355 (1.13%)
|
4 |
3/354 (0.85%)
|
3 |
Eye infection |
1/355 (0.28%)
|
1 |
1/354 (0.28%)
|
1 |
Eye infection intraocular |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Gallbladder infection |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Gingival infection |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
3 |
Hepatic infection |
2/355 (0.56%)
|
2 |
3/354 (0.85%)
|
3 |
Infection |
30/355 (8.45%)
|
41 |
26/354 (7.34%)
|
33 |
Infectious colitis |
8/355 (2.25%)
|
8 |
9/354 (2.54%)
|
10 |
Joint infection |
0/355 (0.00%)
|
0 |
2/354 (0.56%)
|
2 |
Kidney infection |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Lip infection |
5/355 (1.41%)
|
5 |
8/354 (2.26%)
|
9 |
Lymph gland infection |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Mucosal infection |
1/355 (0.28%)
|
1 |
1/354 (0.28%)
|
1 |
Nail infection |
3/355 (0.85%)
|
3 |
0/354 (0.00%)
|
0 |
Opportunistic infection |
3/355 (0.85%)
|
3 |
1/354 (0.28%)
|
1 |
Otitis externa |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
2 |
Otitis media |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Paranasal sinus infection |
1/355 (0.28%)
|
1 |
3/354 (0.85%)
|
3 |
Penile infection |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Pharyngitis |
3/355 (0.85%)
|
4 |
2/354 (0.56%)
|
2 |
Phlebitis infective |
2/355 (0.56%)
|
2 |
1/354 (0.28%)
|
1 |
Pleural infection |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Pneumonia |
25/355 (7.04%)
|
32 |
35/354 (9.89%)
|
39 |
Rhinitis infective |
1/355 (0.28%)
|
1 |
1/354 (0.28%)
|
1 |
Salivary gland infection |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Sepsis |
23/355 (6.48%)
|
27 |
16/354 (4.52%)
|
17 |
Sinusitis |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Skin infection |
8/355 (2.25%)
|
9 |
8/354 (2.26%)
|
9 |
Small intestine infection |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Soft tissue infection |
0/355 (0.00%)
|
0 |
4/354 (1.13%)
|
4 |
Splenic infection |
2/355 (0.56%)
|
2 |
1/354 (0.28%)
|
1 |
Tooth infection |
1/355 (0.28%)
|
1 |
4/354 (1.13%)
|
5 |
Upper aerodigestive tract infection |
1/355 (0.28%)
|
1 |
1/354 (0.28%)
|
1 |
Urinary tract infection |
8/355 (2.25%)
|
10 |
15/354 (4.24%)
|
19 |
Vulval infection |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Wound infection |
4/355 (1.13%)
|
4 |
2/354 (0.56%)
|
2 |
Injury, poisoning and procedural complications |
|
|
Bruising |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Fracture |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Gastrointestinal anastomotic leak |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Intraoperative complications |
2/355 (0.56%)
|
2 |
0/354 (0.00%)
|
0 |
Intraoperative gastrointestinal injury |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Intraoperative gastrointestinal injury - Appendix |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Intraoperative reproductive tract injury - Ovary |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Intraoperative reproductive tract injury - Testis |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Kidney anastomotic leak |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Postoperative hemorrhage |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Thermal burn |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Vascular access complication |
3/355 (0.85%)
|
3 |
3/354 (0.85%)
|
3 |
Wound dehiscence |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Investigations |
|
|
Activated partial thromboplastin time prolonged |
9/355 (2.54%)
|
15 |
9/354 (2.54%)
|
11 |
Alanine aminotransferase increased |
35/355 (9.86%)
|
41 |
35/354 (9.89%)
|
41 |
Alkaline phosphatase increased |
8/355 (2.25%)
|
8 |
20/354 (5.65%)
|
24 |
Amylase increased |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Aspartate aminotransferase increased |
30/355 (8.45%)
|
33 |
29/354 (8.19%)
|
32 |
Blood bilirubin increased |
25/355 (7.04%)
|
32 |
36/354 (10.17%)
|
42 |
CD4 lymphocytes decreased |
1/355 (0.28%)
|
3 |
0/354 (0.00%)
|
0 |
Cardiac troponin T increased |
2/355 (0.56%)
|
2 |
1/354 (0.28%)
|
1 |
Coagulopathy |
8/355 (2.25%)
|
14 |
7/354 (1.98%)
|
11 |
Creatinine increased |
15/355 (4.23%)
|
16 |
16/354 (4.52%)
|
17 |
Electrocardiogram QTc interval prolonged |
17/355 (4.79%)
|
22 |
19/354 (5.37%)
|
22 |
Fibrinogen decreased |
2/355 (0.56%)
|
2 |
7/354 (1.98%)
|
7 |
Gamma-glutamyltransferase increased |
19/355 (5.35%)
|
25 |
22/354 (6.21%)
|
32 |
INR increased |
8/355 (2.25%)
|
10 |
5/354 (1.41%)
|
5 |
Laboratory test abnormal |
18/355 (5.07%)
|
33 |
28/354 (7.91%)
|
47 |
Leukocyte count decreased |
41/355 (11.55%)
|
66 |
47/354 (13.28%)
|
78 |
Lipase increased |
2/355 (0.56%)
|
2 |
1/354 (0.28%)
|
1 |
Lymphocyte count decreased |
22/355 (6.20%)
|
30 |
36/354 (10.17%)
|
56 |
Neutrophil count decreased |
145/355 (40.85%)
|
227 |
146/354 (41.24%)
|
224 |
Platelet count decreased |
155/355 (43.66%)
|
239 |
146/354 (41.24%)
|
227 |
Serum cholesterol increased |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Weight gain |
3/355 (0.85%)
|
3 |
3/354 (0.85%)
|
3 |
Weight loss |
1/355 (0.28%)
|
1 |
11/354 (3.11%)
|
13 |
Metabolism and nutrition disorders |
|
|
Acidosis |
2/355 (0.56%)
|
2 |
1/354 (0.28%)
|
1 |
Anorexia |
21/355 (5.92%)
|
30 |
26/354 (7.34%)
|
29 |
Blood glucose increased |
17/355 (4.79%)
|
23 |
22/354 (6.21%)
|
31 |
Blood uric acid increased |
6/355 (1.69%)
|
10 |
4/354 (1.13%)
|
4 |
Dehydration |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Glucose intolerance |
0/355 (0.00%)
|
0 |
2/354 (0.56%)
|
2 |
Serum albumin decreased |
19/355 (5.35%)
|
28 |
22/354 (6.21%)
|
26 |
Serum calcium decreased |
20/355 (5.63%)
|
25 |
26/354 (7.34%)
|
30 |
Serum calcium increased |
2/355 (0.56%)
|
2 |
1/354 (0.28%)
|
1 |
Serum glucose decreased |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
3 |
Serum magnesium decreased |
15/355 (4.23%)
|
19 |
15/354 (4.24%)
|
22 |
Serum phosphate decreased |
7/355 (1.97%)
|
9 |
12/354 (3.39%)
|
13 |
Serum potassium decreased |
31/355 (8.73%)
|
37 |
47/354 (13.28%)
|
53 |
Serum potassium increased |
8/355 (2.25%)
|
9 |
4/354 (1.13%)
|
4 |
Serum sodium decreased |
20/355 (5.63%)
|
22 |
20/354 (5.65%)
|
22 |
Serum sodium increased |
5/355 (1.41%)
|
5 |
5/354 (1.41%)
|
5 |
Serum triglycerides increased |
3/355 (0.85%)
|
4 |
0/354 (0.00%)
|
0 |
Tumor lysis syndrome |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
2 |
Musculoskeletal and connective tissue disorders |
|
|
Arthralgia |
8/355 (2.25%)
|
8 |
6/354 (1.69%)
|
6 |
Arthritis |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
2 |
Back pain |
15/355 (4.23%)
|
19 |
13/354 (3.67%)
|
13 |
Bone pain |
7/355 (1.97%)
|
8 |
4/354 (1.13%)
|
5 |
Buttock pain |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Chest wall pain |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
2 |
Joint effusion |
1/355 (0.28%)
|
1 |
1/354 (0.28%)
|
1 |
Muscle weakness |
3/355 (0.85%)
|
3 |
2/354 (0.56%)
|
3 |
Musculoskeletal disorder |
4/355 (1.13%)
|
4 |
4/354 (1.13%)
|
4 |
Myalgia |
7/355 (1.97%)
|
7 |
4/354 (1.13%)
|
5 |
Neck pain |
7/355 (1.97%)
|
8 |
4/354 (1.13%)
|
5 |
Pain in extremity |
5/355 (1.41%)
|
6 |
6/354 (1.69%)
|
9 |
Trismus |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Nervous system disorders |
|
|
Ataxia |
1/355 (0.28%)
|
1 |
3/354 (0.85%)
|
3 |
Depressed level of consciousness |
2/355 (0.56%)
|
2 |
1/354 (0.28%)
|
1 |
Dizziness |
19/355 (5.35%)
|
23 |
20/354 (5.65%)
|
25 |
Dysgeusia |
4/355 (1.13%)
|
4 |
7/354 (1.98%)
|
9 |
Encephalopathy |
1/355 (0.28%)
|
1 |
1/354 (0.28%)
|
1 |
Extrapyramidal disorder |
1/355 (0.28%)
|
1 |
1/354 (0.28%)
|
1 |
Headache |
41/355 (11.55%)
|
54 |
42/354 (11.86%)
|
63 |
Intracranial hemorrhage |
3/355 (0.85%)
|
3 |
6/354 (1.69%)
|
6 |
Ischemia cerebrovascular |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Memory impairment |
2/355 (0.56%)
|
2 |
0/354 (0.00%)
|
0 |
Neuralgia |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Neurological disorder NOS |
9/355 (2.54%)
|
11 |
4/354 (1.13%)
|
4 |
Nystagmus |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Peripheral motor neuropathy |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Peripheral sensory neuropathy |
5/355 (1.41%)
|
5 |
6/354 (1.69%)
|
11 |
Seizure |
1/355 (0.28%)
|
1 |
1/354 (0.28%)
|
1 |
Speech disorder |
4/355 (1.13%)
|
4 |
1/354 (0.28%)
|
1 |
Syncope |
6/355 (1.69%)
|
6 |
4/354 (1.13%)
|
4 |
Syncope vasovagal |
1/355 (0.28%)
|
1 |
1/354 (0.28%)
|
1 |
Tremor |
4/355 (1.13%)
|
4 |
3/354 (0.85%)
|
3 |
Psychiatric disorders |
|
|
Agitation |
3/355 (0.85%)
|
5 |
3/354 (0.85%)
|
3 |
Anxiety |
5/355 (1.41%)
|
5 |
9/354 (2.54%)
|
11 |
Confusion |
4/355 (1.13%)
|
4 |
3/354 (0.85%)
|
3 |
Depression |
2/355 (0.56%)
|
2 |
12/354 (3.39%)
|
12 |
Euphoria |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Insomnia |
11/355 (3.10%)
|
14 |
7/354 (1.98%)
|
11 |
Personality change |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Psychosis |
4/355 (1.13%)
|
4 |
2/354 (0.56%)
|
2 |
Renal and urinary disorders |
|
|
Bladder hemorrhage |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Bladder pain |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Cystitis |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Glomerular filtration rate decreased |
2/355 (0.56%)
|
2 |
1/354 (0.28%)
|
1 |
Hemorrhage urinary tract |
2/355 (0.56%)
|
2 |
6/354 (1.69%)
|
6 |
Proteinuria |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Renal failure |
13/355 (3.66%)
|
13 |
9/354 (2.54%)
|
9 |
Renal hemorrhage |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Ureteric obstruction |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Urethral pain |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Urinary frequency |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
2 |
Urinary incontinence |
2/355 (0.56%)
|
2 |
1/354 (0.28%)
|
1 |
Urinary retention |
2/355 (0.56%)
|
2 |
3/354 (0.85%)
|
3 |
Urine discoloration |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Urogenital disorder |
15/355 (4.23%)
|
21 |
11/354 (3.11%)
|
15 |
Reproductive system and breast disorders |
|
|
Breast pain |
0/355 (0.00%)
|
0 |
2/354 (0.56%)
|
2 |
Penile pain |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Perineal pain |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Reproductive tract disorder |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Uterine hemorrhage |
4/355 (1.13%)
|
5 |
3/354 (0.85%)
|
4 |
Vaginal hemorrhage |
5/355 (1.41%)
|
5 |
9/354 (2.54%)
|
9 |
Vaginal mucositis |
1/355 (0.28%)
|
1 |
1/354 (0.28%)
|
1 |
Vaginal pain |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Respiratory, thoracic and mediastinal disorders |
|
|
Adult respiratory distress syndrome |
9/355 (2.54%)
|
9 |
5/354 (1.41%)
|
5 |
Allergic rhinitis |
1/355 (0.28%)
|
1 |
3/354 (0.85%)
|
4 |
Aspiration |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Atelectasis |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Bronchopulmonary hemorrhage |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Bronchospasm |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
2 |
Cough |
17/355 (4.79%)
|
21 |
19/354 (5.37%)
|
20 |
Dyspnea |
20/355 (5.63%)
|
22 |
24/354 (6.78%)
|
24 |
Epistaxis |
24/355 (6.76%)
|
26 |
22/354 (6.21%)
|
24 |
Hiccups |
2/355 (0.56%)
|
2 |
0/354 (0.00%)
|
0 |
Hypoxia |
8/355 (2.25%)
|
8 |
12/354 (3.39%)
|
12 |
Laryngeal edema |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Laryngeal mucositis |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Laryngeal pain |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Laryngoscopy abnormal |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Nasal congestion |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Pharyngeal examination abnormal |
3/355 (0.85%)
|
3 |
2/354 (0.56%)
|
2 |
Pharyngeal mucositis |
2/355 (0.56%)
|
2 |
0/354 (0.00%)
|
0 |
Pharyngolaryngeal pain |
6/355 (1.69%)
|
6 |
11/354 (3.11%)
|
12 |
Pleural effusion |
8/355 (2.25%)
|
8 |
8/354 (2.26%)
|
8 |
Pleuritic pain |
1/355 (0.28%)
|
1 |
1/354 (0.28%)
|
1 |
Pneumonitis |
27/355 (7.61%)
|
28 |
17/354 (4.80%)
|
19 |
Pneumothorax |
2/355 (0.56%)
|
2 |
1/354 (0.28%)
|
1 |
Pulmonary hemorrhage |
1/355 (0.28%)
|
1 |
1/354 (0.28%)
|
1 |
Pulmonary hypertension |
2/355 (0.56%)
|
2 |
0/354 (0.00%)
|
0 |
Respiratory disorder |
12/355 (3.38%)
|
12 |
9/354 (2.54%)
|
9 |
Respiratory tract hemorrhage |
2/355 (0.56%)
|
2 |
1/354 (0.28%)
|
1 |
Retinoic acid syndrome |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Tracheal stenosis |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Voice alteration |
2/355 (0.56%)
|
2 |
0/354 (0.00%)
|
0 |
Skin and subcutaneous tissue disorders |
|
|
Alopecia |
6/355 (1.69%)
|
8 |
4/354 (1.13%)
|
4 |
Decubitus ulcer |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
2 |
Dry skin |
7/355 (1.97%)
|
8 |
7/354 (1.98%)
|
7 |
Erythema multiforme |
3/355 (0.85%)
|
3 |
3/354 (0.85%)
|
3 |
Hand-and-foot syndrome |
2/355 (0.56%)
|
4 |
5/354 (1.41%)
|
5 |
Nail disorder |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Pain of skin |
1/355 (0.28%)
|
1 |
1/354 (0.28%)
|
1 |
Petechiae |
35/355 (9.86%)
|
45 |
34/354 (9.60%)
|
52 |
Pruritus |
11/355 (3.10%)
|
13 |
12/354 (3.39%)
|
13 |
Rash acneiform |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Rash desquamating |
59/355 (16.62%)
|
70 |
66/354 (18.64%)
|
71 |
Skin disorder |
23/355 (6.48%)
|
28 |
23/354 (6.50%)
|
30 |
Skin hyperpigmentation |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Skin ulceration |
2/355 (0.56%)
|
2 |
2/354 (0.56%)
|
2 |
Sweating |
14/355 (3.94%)
|
19 |
14/354 (3.95%)
|
15 |
Urticaria |
3/355 (0.85%)
|
3 |
3/354 (0.85%)
|
4 |
Vascular disorders |
|
|
Flushing |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Hematoma |
14/355 (3.94%)
|
17 |
13/354 (3.67%)
|
17 |
Hemorrhage |
14/355 (3.94%)
|
19 |
12/354 (3.39%)
|
13 |
Hot flashes |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
2 |
Hypertension |
13/355 (3.66%)
|
13 |
11/354 (3.11%)
|
11 |
Hypotension |
25/355 (7.04%)
|
26 |
19/354 (5.37%)
|
22 |
Lymphangitic streak |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Lymphedema |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Phlebitis |
6/355 (1.69%)
|
7 |
7/354 (1.98%)
|
7 |
Thrombosis |
2/355 (0.56%)
|
2 |
0/354 (0.00%)
|
0 |
Vascular disorder |
2/355 (0.56%)
|
2 |
2/354 (0.56%)
|
2 |
Vasculitis |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA 6
|
|
Frequency Threshold for Reporting Other Adverse Events
|
0%
|
|
Induction and Consolidation Chemotherapy Plus Midostaurin
|
Induction and Consolidation Chemotherapy Plus Placebo
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
321/355 (90.42%)
|
|
324/354 (91.53%)
|
|
Blood and lymphatic system disorders |
|
|
Blood disorder |
5/355 (1.41%)
|
11 |
4/354 (1.13%)
|
6 |
Disseminated intravascular coagulation |
2/355 (0.56%)
|
2 |
1/354 (0.28%)
|
1 |
Febrile neutropenia |
246/355 (69.30%)
|
422 |
238/354 (67.23%)
|
394 |
Hemoglobin decreased |
312/355 (87.89%)
|
1059 |
311/354 (87.85%)
|
940 |
Lymph node pain |
2/355 (0.56%)
|
2 |
0/354 (0.00%)
|
0 |
Lymphatic disorder |
10/355 (2.82%)
|
13 |
9/354 (2.54%)
|
11 |
Cardiac disorders |
|
|
Arrhythmia |
1/355 (0.28%)
|
1 |
4/354 (1.13%)
|
4 |
Atrial fibrillation |
3/355 (0.85%)
|
3 |
0/354 (0.00%)
|
0 |
Atrial flutter |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Atrial tachycardia |
1/355 (0.28%)
|
3 |
1/354 (0.28%)
|
1 |
Cardiac disorder |
8/355 (2.25%)
|
12 |
13/354 (3.67%)
|
17 |
Cardiac pain |
4/355 (1.13%)
|
6 |
1/354 (0.28%)
|
1 |
Cardiac valve disease |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Conduction disorder |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
2 |
Left ventricular failure |
6/355 (1.69%)
|
6 |
5/354 (1.41%)
|
9 |
Myocardial ischemia |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Palpitations |
3/355 (0.85%)
|
3 |
5/354 (1.41%)
|
13 |
Pericardial effusion |
7/355 (1.97%)
|
8 |
1/354 (0.28%)
|
1 |
Pericarditis |
2/355 (0.56%)
|
2 |
1/354 (0.28%)
|
1 |
Premature ventricular contractions |
1/355 (0.28%)
|
3 |
0/354 (0.00%)
|
0 |
Sinus bradycardia |
10/355 (2.82%)
|
10 |
5/354 (1.41%)
|
15 |
Sinus tachycardia |
11/355 (3.10%)
|
13 |
23/354 (6.50%)
|
29 |
Supraventricular extrasystoles |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
7 |
Supraventricular tachycardia |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
2 |
Ventricular arrhythmia |
1/355 (0.28%)
|
1 |
1/354 (0.28%)
|
1 |
Ventricular bigeminy |
1/355 (0.28%)
|
2 |
0/354 (0.00%)
|
0 |
Ventricular fibrillation |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Ventricular tachycardia |
1/355 (0.28%)
|
1 |
1/354 (0.28%)
|
1 |
Ear and labyrinth disorders |
|
|
Ear disorder |
5/355 (1.41%)
|
5 |
3/354 (0.85%)
|
3 |
Ear pain |
5/355 (1.41%)
|
6 |
6/354 (1.69%)
|
6 |
External ear inflammation |
0/355 (0.00%)
|
0 |
2/354 (0.56%)
|
2 |
External ear pain |
3/355 (0.85%)
|
3 |
2/354 (0.56%)
|
2 |
Hearing impaired |
2/355 (0.56%)
|
4 |
2/354 (0.56%)
|
2 |
Middle ear inflammation |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Tinnitus |
3/355 (0.85%)
|
3 |
2/354 (0.56%)
|
2 |
Endocrine disorders |
|
|
Endocrine disorder |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
2 |
Hyperthyroidism |
2/355 (0.56%)
|
7 |
1/354 (0.28%)
|
3 |
Hypothyroidism |
2/355 (0.56%)
|
2 |
2/354 (0.56%)
|
5 |
Eye disorders |
|
|
Cataract |
1/355 (0.28%)
|
9 |
0/354 (0.00%)
|
0 |
Conjunctivitis |
7/355 (1.97%)
|
7 |
4/354 (1.13%)
|
5 |
Dry eye syndrome |
5/355 (1.41%)
|
7 |
10/354 (2.82%)
|
12 |
Eye disorder |
21/355 (5.92%)
|
28 |
16/354 (4.52%)
|
19 |
Eye pain |
5/355 (1.41%)
|
5 |
5/354 (1.41%)
|
5 |
Eyelid function disorder |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Flashing vision |
1/355 (0.28%)
|
1 |
4/354 (1.13%)
|
5 |
Keratitis |
14/355 (3.94%)
|
17 |
9/354 (2.54%)
|
14 |
Optic nerve disorder |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Photophobia |
2/355 (0.56%)
|
3 |
4/354 (1.13%)
|
4 |
Vision blurred |
5/355 (1.41%)
|
8 |
4/354 (1.13%)
|
7 |
Vitreous hemorrhage |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
2 |
Watering eyes |
4/355 (1.13%)
|
7 |
2/354 (0.56%)
|
2 |
Gastrointestinal disorders |
|
|
Abdominal distension |
6/355 (1.69%)
|
15 |
10/354 (2.82%)
|
11 |
Abdominal pain |
57/355 (16.06%)
|
78 |
67/354 (18.93%)
|
84 |
Anal exam abnormal |
0/355 (0.00%)
|
0 |
3/354 (0.85%)
|
3 |
Anal fistula |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Anal hemorrhage |
2/355 (0.56%)
|
2 |
3/354 (0.85%)
|
3 |
Anal mucositis |
2/355 (0.56%)
|
2 |
2/354 (0.56%)
|
3 |
Anal pain |
12/355 (3.38%)
|
15 |
6/354 (1.69%)
|
8 |
Anal ulcer |
1/355 (0.28%)
|
1 |
3/354 (0.85%)
|
3 |
Ascites |
1/355 (0.28%)
|
1 |
1/354 (0.28%)
|
1 |
Colitis |
7/355 (1.97%)
|
9 |
12/354 (3.39%)
|
18 |
Colonic hemorrhage |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Colonic perforation |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
2 |
Constipation |
50/355 (14.08%)
|
86 |
60/354 (16.95%)
|
83 |
Dental prosthesis user |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Diarrhea |
228/355 (64.23%)
|
432 |
219/354 (61.86%)
|
310 |
Dry mouth |
2/355 (0.56%)
|
2 |
2/354 (0.56%)
|
2 |
Dyspepsia |
22/355 (6.20%)
|
36 |
16/354 (4.52%)
|
17 |
Dysphagia |
6/355 (1.69%)
|
6 |
10/354 (2.82%)
|
10 |
Ear, nose and throat examination abnormal |
112/355 (31.55%)
|
178 |
112/354 (31.64%)
|
169 |
Endoscopy large bowel abnormal |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Enteritis |
1/355 (0.28%)
|
1 |
3/354 (0.85%)
|
3 |
Esophageal mucositis |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Esophageal pain |
1/355 (0.28%)
|
1 |
3/354 (0.85%)
|
3 |
Esophageal perforation |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Esophageal ulcer |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Esophagitis |
3/355 (0.85%)
|
3 |
4/354 (1.13%)
|
4 |
Flatulence |
10/355 (2.82%)
|
20 |
7/354 (1.98%)
|
8 |
Gastric hemorrhage |
2/355 (0.56%)
|
2 |
1/354 (0.28%)
|
1 |
Gastric mucositis |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Gastric ulcer |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Gastritis |
3/355 (0.85%)
|
3 |
4/354 (1.13%)
|
4 |
Gastrointestinal disorder |
28/355 (7.89%)
|
35 |
26/354 (7.34%)
|
29 |
Gastrointestinal pain |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Gastroscopy abnormal |
0/355 (0.00%)
|
0 |
3/354 (0.85%)
|
3 |
Gingival pain |
3/355 (0.85%)
|
3 |
4/354 (1.13%)
|
4 |
Hemorrhoidal hemorrhage |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
3 |
Hemorrhoids |
28/355 (7.89%)
|
36 |
21/354 (5.93%)
|
25 |
Ileal obstruction |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Ileus |
2/355 (0.56%)
|
3 |
3/354 (0.85%)
|
3 |
Large intestinal mucositis |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Lower gastrointestinal hemorrhage |
0/355 (0.00%)
|
0 |
2/354 (0.56%)
|
2 |
Mucositis oral |
49/355 (13.80%)
|
59 |
31/354 (8.76%)
|
36 |
Nausea |
258/355 (72.68%)
|
807 |
226/354 (63.84%)
|
449 |
Oesophagoscopy abnormal |
2/355 (0.56%)
|
2 |
1/354 (0.28%)
|
1 |
Oral hemorrhage |
12/355 (3.38%)
|
13 |
18/354 (5.08%)
|
27 |
Oral pain |
8/355 (2.25%)
|
10 |
11/354 (3.11%)
|
11 |
Periodontal disease |
4/355 (1.13%)
|
6 |
7/354 (1.98%)
|
7 |
Peritoneal pain |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Proctitis |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Proctoscopy abnormal |
3/355 (0.85%)
|
3 |
0/354 (0.00%)
|
0 |
Rectal hemorrhage |
7/355 (1.97%)
|
8 |
5/354 (1.41%)
|
7 |
Rectal obstruction |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Rectal pain |
5/355 (1.41%)
|
6 |
2/354 (0.56%)
|
2 |
Salivary gland disorder |
0/355 (0.00%)
|
0 |
2/354 (0.56%)
|
2 |
Small intestinal mucositis |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
2 |
Stomach pain |
34/355 (9.58%)
|
43 |
27/354 (7.63%)
|
32 |
Tooth development disorder |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Tooth disorder |
6/355 (1.69%)
|
6 |
2/354 (0.56%)
|
2 |
Toothache |
9/355 (2.54%)
|
11 |
10/354 (2.82%)
|
10 |
Typhlitis |
3/355 (0.85%)
|
3 |
4/354 (1.13%)
|
4 |
Upper gastrointestinal hemorrhage |
2/355 (0.56%)
|
2 |
0/354 (0.00%)
|
0 |
Vomiting |
188/355 (52.96%)
|
376 |
168/354 (47.46%)
|
259 |
General disorders |
|
|
Chest pain |
15/355 (4.23%)
|
17 |
20/354 (5.65%)
|
28 |
Chills |
22/355 (6.20%)
|
26 |
17/354 (4.80%)
|
21 |
Disease progression |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Edema limbs |
33/355 (9.30%)
|
43 |
39/354 (11.02%)
|
56 |
Facial pain |
2/355 (0.56%)
|
2 |
1/354 (0.28%)
|
1 |
Fatigue |
221/355 (62.25%)
|
522 |
220/354 (62.15%)
|
474 |
Fever |
72/355 (20.28%)
|
110 |
69/354 (19.49%)
|
107 |
Flu-like symptoms |
5/355 (1.41%)
|
5 |
2/354 (0.56%)
|
2 |
Gait abnormal |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
General symptom |
15/355 (4.23%)
|
18 |
17/354 (4.80%)
|
25 |
Hypothermia |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Ill-defined disorder |
3/355 (0.85%)
|
4 |
4/354 (1.13%)
|
4 |
Injection site reaction |
20/355 (5.63%)
|
25 |
23/354 (6.50%)
|
34 |
Localized edema |
16/355 (4.51%)
|
16 |
14/354 (3.95%)
|
19 |
Pain |
40/355 (11.27%)
|
55 |
33/354 (9.32%)
|
44 |
Visceral edema |
2/355 (0.56%)
|
2 |
2/354 (0.56%)
|
2 |
Hepatobiliary disorders |
|
|
Cholecystitis |
1/355 (0.28%)
|
1 |
1/354 (0.28%)
|
1 |
Gallbladder pain |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Hepatic failure |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Hepatobiliary disease |
4/355 (1.13%)
|
16 |
4/354 (1.13%)
|
5 |
Immune system disorders |
|
|
Cytokine release syndrome |
1/355 (0.28%)
|
2 |
0/354 (0.00%)
|
0 |
Hypersensitivity |
36/355 (10.14%)
|
41 |
30/354 (8.47%)
|
41 |
Immune system disorder |
12/355 (3.38%)
|
14 |
9/354 (2.54%)
|
14 |
Infections and infestations |
|
|
Abdominal infection |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Anal infection |
8/355 (2.25%)
|
9 |
8/354 (2.26%)
|
12 |
Anorectal infection |
2/355 (0.56%)
|
3 |
1/354 (0.28%)
|
1 |
Appendicitis |
0/355 (0.00%)
|
0 |
2/354 (0.56%)
|
2 |
Bladder infection |
8/355 (2.25%)
|
13 |
10/354 (2.82%)
|
11 |
Bone infection |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Bronchitis |
7/355 (1.97%)
|
9 |
6/354 (1.69%)
|
6 |
Catheter related infection |
55/355 (15.49%)
|
74 |
43/354 (12.15%)
|
54 |
Cecal infection |
1/355 (0.28%)
|
1 |
1/354 (0.28%)
|
2 |
Colitis, infectious (e.g., Clostridium difficile) |
4/355 (1.13%)
|
4 |
4/354 (1.13%)
|
4 |
Conjunctivitis infective |
8/355 (2.25%)
|
10 |
5/354 (1.41%)
|
7 |
Device related infection |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Eye infection |
2/355 (0.56%)
|
2 |
0/354 (0.00%)
|
0 |
Gastric infection |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
3 |
Gingival infection |
5/355 (1.41%)
|
6 |
3/354 (0.85%)
|
3 |
Hepatic infection |
3/355 (0.85%)
|
3 |
5/354 (1.41%)
|
14 |
Infection |
57/355 (16.06%)
|
100 |
60/354 (16.95%)
|
99 |
Infectious colitis |
5/355 (1.41%)
|
7 |
5/354 (1.41%)
|
5 |
Kidney infection |
2/355 (0.56%)
|
2 |
1/354 (0.28%)
|
1 |
Lip infection |
17/355 (4.79%)
|
22 |
21/354 (5.93%)
|
29 |
Lymph gland infection |
1/355 (0.28%)
|
1 |
3/354 (0.85%)
|
4 |
Mediastinal infection |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Mucosal infection |
2/355 (0.56%)
|
2 |
0/354 (0.00%)
|
0 |
Nail infection |
3/355 (0.85%)
|
4 |
2/354 (0.56%)
|
2 |
Opportunistic infection |
4/355 (1.13%)
|
5 |
9/354 (2.54%)
|
14 |
Otitis media |
2/355 (0.56%)
|
3 |
0/354 (0.00%)
|
0 |
Paranasal sinus infection |
2/355 (0.56%)
|
2 |
1/354 (0.28%)
|
1 |
Penile infection |
2/355 (0.56%)
|
2 |
0/354 (0.00%)
|
0 |
Pharyngitis |
5/355 (1.41%)
|
5 |
7/354 (1.98%)
|
7 |
Phlebitis infective |
3/355 (0.85%)
|
5 |
2/354 (0.56%)
|
2 |
Pneumonia |
36/355 (10.14%)
|
53 |
36/354 (10.17%)
|
45 |
Rhinitis infective |
6/355 (1.69%)
|
12 |
6/354 (1.69%)
|
7 |
Scrotal infection |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Sepsis |
26/355 (7.32%)
|
29 |
20/354 (5.65%)
|
23 |
Sinusitis |
7/355 (1.97%)
|
7 |
5/354 (1.41%)
|
6 |
Skin infection |
22/355 (6.20%)
|
24 |
15/354 (4.24%)
|
19 |
Soft tissue infection |
2/355 (0.56%)
|
2 |
1/354 (0.28%)
|
1 |
Splenic infection |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
9 |
Tooth infection |
4/355 (1.13%)
|
4 |
4/354 (1.13%)
|
5 |
Tracheitis |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Upper aerodigestive tract infection |
0/355 (0.00%)
|
0 |
4/354 (1.13%)
|
4 |
Upper respiratory infection |
11/355 (3.10%)
|
17 |
8/354 (2.26%)
|
14 |
Ureteritis |
4/355 (1.13%)
|
6 |
4/354 (1.13%)
|
6 |
Urinary tract infection |
15/355 (4.23%)
|
17 |
15/354 (4.24%)
|
19 |
Vaginal infection |
5/355 (1.41%)
|
6 |
8/354 (2.26%)
|
12 |
Viral hepatitis |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Vulval infection |
2/355 (0.56%)
|
2 |
0/354 (0.00%)
|
0 |
Vulvitis |
0/355 (0.00%)
|
0 |
2/354 (0.56%)
|
2 |
Wound infection |
3/355 (0.85%)
|
3 |
3/354 (0.85%)
|
3 |
Injury, poisoning and procedural complications |
|
|
Bruising |
3/355 (0.85%)
|
3 |
1/354 (0.28%)
|
1 |
Device complication |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Fracture |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Injury to inferior vena cava |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Injury to jugular vein |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Intraoperative complications |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Intraoperative gastrointestinal injury |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Intraoperative gastrointestinal injury - Teeth |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Intraoperative head and neck injury - Neck NOS |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Intraoperative ocular injury - Lens |
1/355 (0.28%)
|
2 |
0/354 (0.00%)
|
0 |
Postoperative hemorrhage |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Radiation recall reaction (dermatologic) |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Thermal burn |
0/355 (0.00%)
|
0 |
3/354 (0.85%)
|
3 |
Tracheostomy site bleeding |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Vaginal anastomotic leak |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Vascular access complication |
9/355 (2.54%)
|
15 |
6/354 (1.69%)
|
6 |
Venous injury - Extremity-lower |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Wound dehiscence |
2/355 (0.56%)
|
2 |
0/354 (0.00%)
|
0 |
Investigations |
|
|
Activated partial thromboplastin time prolonged |
26/355 (7.32%)
|
36 |
22/354 (6.21%)
|
27 |
Alanine aminotransferase increased |
88/355 (24.79%)
|
312 |
83/354 (23.45%)
|
184 |
Alkaline phosphatase increased |
30/355 (8.45%)
|
60 |
29/354 (8.19%)
|
55 |
Amylase increased |
1/355 (0.28%)
|
1 |
1/354 (0.28%)
|
1 |
Aspartate aminotransferase increased |
60/355 (16.90%)
|
201 |
56/354 (15.82%)
|
102 |
Blood bilirubin increased |
49/355 (13.80%)
|
86 |
60/354 (16.95%)
|
104 |
Cardiac troponin T increased |
1/355 (0.28%)
|
1 |
1/354 (0.28%)
|
1 |
Coagulopathy |
7/355 (1.97%)
|
8 |
10/354 (2.82%)
|
14 |
Creatinine increased |
13/355 (3.66%)
|
18 |
15/354 (4.24%)
|
25 |
Electrocardiogram QTc interval prolonged |
45/355 (12.68%)
|
81 |
36/354 (10.17%)
|
48 |
Fibrinogen decreased |
12/355 (3.38%)
|
14 |
8/354 (2.26%)
|
10 |
Forced expiratory volume decreased |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Gamma-glutamyltransferase increased |
25/355 (7.04%)
|
55 |
34/354 (9.60%)
|
57 |
INR increased |
9/355 (2.54%)
|
11 |
12/354 (3.39%)
|
12 |
Laboratory test abnormal |
31/355 (8.73%)
|
53 |
41/354 (11.58%)
|
81 |
Leukocyte count decreased |
79/355 (22.25%)
|
240 |
92/354 (25.99%)
|
204 |
Lymphocyte count decreased |
69/355 (19.44%)
|
195 |
71/354 (20.06%)
|
158 |
Neutrophil count decreased |
308/355 (86.76%)
|
952 |
308/354 (87.01%)
|
879 |
Platelet count decreased |
311/355 (87.61%)
|
1131 |
313/354 (88.42%)
|
1020 |
Serum cholesterol increased |
0/355 (0.00%)
|
0 |
5/354 (1.41%)
|
10 |
Weight gain |
15/355 (4.23%)
|
26 |
6/354 (1.69%)
|
11 |
Weight loss |
9/355 (2.54%)
|
12 |
10/354 (2.82%)
|
12 |
Metabolism and nutrition disorders |
|
|
Alkalosis |
0/355 (0.00%)
|
0 |
3/354 (0.85%)
|
3 |
Anorexia |
30/355 (8.45%)
|
40 |
40/354 (11.30%)
|
50 |
Blood glucose increased |
72/355 (20.28%)
|
202 |
59/354 (16.67%)
|
134 |
Blood uric acid increased |
21/355 (5.92%)
|
42 |
15/354 (4.24%)
|
23 |
Dehydration |
1/355 (0.28%)
|
1 |
1/354 (0.28%)
|
1 |
Glucose intolerance |
0/355 (0.00%)
|
0 |
2/354 (0.56%)
|
5 |
Iron overload |
0/355 (0.00%)
|
0 |
2/354 (0.56%)
|
4 |
Serum albumin decreased |
56/355 (15.77%)
|
101 |
56/354 (15.82%)
|
80 |
Serum calcium decreased |
58/355 (16.34%)
|
88 |
56/354 (15.82%)
|
79 |
Serum calcium increased |
6/355 (1.69%)
|
11 |
1/354 (0.28%)
|
2 |
Serum glucose decreased |
6/355 (1.69%)
|
8 |
9/354 (2.54%)
|
10 |
Serum magnesium decreased |
30/355 (8.45%)
|
48 |
32/354 (9.04%)
|
65 |
Serum magnesium increased |
7/355 (1.97%)
|
8 |
3/354 (0.85%)
|
3 |
Serum phosphate decreased |
27/355 (7.61%)
|
31 |
27/354 (7.63%)
|
40 |
Serum potassium decreased |
79/355 (22.25%)
|
117 |
74/354 (20.90%)
|
112 |
Serum potassium increased |
5/355 (1.41%)
|
5 |
5/354 (1.41%)
|
6 |
Serum sodium decreased |
48/355 (13.52%)
|
63 |
51/354 (14.41%)
|
64 |
Serum sodium increased |
8/355 (2.25%)
|
8 |
8/354 (2.26%)
|
9 |
Serum triglycerides increased |
1/355 (0.28%)
|
1 |
4/354 (1.13%)
|
5 |
Tumor lysis syndrome |
2/355 (0.56%)
|
2 |
3/354 (0.85%)
|
3 |
Musculoskeletal and connective tissue disorders |
|
|
Arthralgia |
30/355 (8.45%)
|
67 |
16/354 (4.52%)
|
25 |
Arthritis |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Back pain |
46/355 (12.96%)
|
74 |
34/354 (9.60%)
|
53 |
Bone pain |
19/355 (5.35%)
|
32 |
21/354 (5.93%)
|
37 |
Buttock pain |
3/355 (0.85%)
|
3 |
0/354 (0.00%)
|
0 |
Chest wall pain |
6/355 (1.69%)
|
9 |
3/354 (0.85%)
|
4 |
Joint disorder |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Joint effusion |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Joint range of motion decreased lumbar spine |
1/355 (0.28%)
|
2 |
0/354 (0.00%)
|
0 |
Muscle weakness |
6/355 (1.69%)
|
6 |
4/354 (1.13%)
|
4 |
Muscle weakness lower limb |
2/355 (0.56%)
|
2 |
1/354 (0.28%)
|
1 |
Musculoskeletal disorder |
13/355 (3.66%)
|
19 |
6/354 (1.69%)
|
8 |
Myalgia |
13/355 (3.66%)
|
24 |
16/354 (4.52%)
|
19 |
Myositis |
0/355 (0.00%)
|
0 |
2/354 (0.56%)
|
2 |
Neck pain |
16/355 (4.51%)
|
18 |
9/354 (2.54%)
|
9 |
Osteoporosis |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Pain in extremity |
30/355 (8.45%)
|
39 |
17/354 (4.80%)
|
23 |
Upper extremity dysfunction |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
Myelodysplasia |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Treatment related secondary malignancy |
1/355 (0.28%)
|
1 |
1/354 (0.28%)
|
2 |
Tumor pain |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Nervous system disorders |
|
|
Ataxia |
2/355 (0.56%)
|
2 |
10/354 (2.82%)
|
11 |
Cognitive disturbance |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Depressed level of consciousness |
2/355 (0.56%)
|
2 |
3/354 (0.85%)
|
3 |
Dizziness |
44/355 (12.39%)
|
64 |
43/354 (12.15%)
|
55 |
Dysgeusia |
5/355 (1.41%)
|
5 |
11/354 (3.11%)
|
14 |
Encephalopathy |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
5 |
Extrapyramidal disorder |
0/355 (0.00%)
|
0 |
2/354 (0.56%)
|
5 |
Headache |
105/355 (29.58%)
|
218 |
85/354 (24.01%)
|
143 |
Intracranial hemorrhage |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
2 |
Memory impairment |
2/355 (0.56%)
|
4 |
1/354 (0.28%)
|
2 |
Neuralgia |
2/355 (0.56%)
|
2 |
3/354 (0.85%)
|
6 |
Neurological disorder NOS |
17/355 (4.79%)
|
22 |
7/354 (1.98%)
|
7 |
Olfactory nerve disorder |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Peripheral motor neuropathy |
2/355 (0.56%)
|
12 |
1/354 (0.28%)
|
1 |
Peripheral sensory neuropathy |
6/355 (1.69%)
|
21 |
11/354 (3.11%)
|
26 |
Pyramidal tract syndrome |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Seizure |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Speech disorder |
1/355 (0.28%)
|
16 |
1/354 (0.28%)
|
1 |
Syncope |
8/355 (2.25%)
|
9 |
6/354 (1.69%)
|
6 |
Syncope vasovagal |
2/355 (0.56%)
|
3 |
7/354 (1.98%)
|
9 |
Tremor |
5/355 (1.41%)
|
8 |
4/354 (1.13%)
|
4 |
Psychiatric disorders |
|
|
Agitation |
4/355 (1.13%)
|
4 |
3/354 (0.85%)
|
3 |
Anxiety |
16/355 (4.51%)
|
21 |
18/354 (5.08%)
|
32 |
Confusion |
4/355 (1.13%)
|
5 |
4/354 (1.13%)
|
4 |
Depression |
14/355 (3.94%)
|
26 |
24/354 (6.78%)
|
50 |
Euphoria |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Insomnia |
30/355 (8.45%)
|
47 |
20/354 (5.65%)
|
35 |
Personality change |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Psychosis |
1/355 (0.28%)
|
1 |
1/354 (0.28%)
|
1 |
Renal and urinary disorders |
|
|
Bladder hemorrhage |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Bladder pain |
3/355 (0.85%)
|
5 |
1/354 (0.28%)
|
1 |
Bladder spasm |
2/355 (0.56%)
|
2 |
0/354 (0.00%)
|
0 |
Cystitis |
5/355 (1.41%)
|
6 |
7/354 (1.98%)
|
8 |
Hemoglobin urine positive |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Hemorrhage urinary tract |
2/355 (0.56%)
|
2 |
4/354 (1.13%)
|
4 |
Kidney pain |
1/355 (0.28%)
|
2 |
0/354 (0.00%)
|
0 |
Proteinuria |
1/355 (0.28%)
|
3 |
1/354 (0.28%)
|
1 |
Renal failure |
3/355 (0.85%)
|
3 |
1/354 (0.28%)
|
1 |
Urethral obstruction |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Urethral pain |
0/355 (0.00%)
|
0 |
2/354 (0.56%)
|
2 |
Urinary frequency |
1/355 (0.28%)
|
1 |
4/354 (1.13%)
|
9 |
Urinary incontinence |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
2 |
Urinary retention |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
3 |
Urine discoloration |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Urogenital disorder |
11/355 (3.10%)
|
12 |
10/354 (2.82%)
|
11 |
Reproductive system and breast disorders |
|
|
Breast pain |
2/355 (0.56%)
|
2 |
0/354 (0.00%)
|
0 |
Gynecomastia |
1/355 (0.28%)
|
1 |
1/354 (0.28%)
|
3 |
Pelvic pain |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
2 |
Perineal pain |
1/355 (0.28%)
|
1 |
1/354 (0.28%)
|
1 |
Reproductive tract disorder |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Uterine hemorrhage |
8/355 (2.25%)
|
12 |
6/354 (1.69%)
|
7 |
Uterine pain |
1/355 (0.28%)
|
1 |
3/354 (0.85%)
|
3 |
Vaginal discharge |
1/355 (0.28%)
|
1 |
1/354 (0.28%)
|
2 |
Vaginal hemorrhage |
16/355 (4.51%)
|
17 |
17/354 (4.80%)
|
24 |
Vaginal inflammation |
1/355 (0.28%)
|
1 |
1/354 (0.28%)
|
1 |
Vaginal mucositis |
2/355 (0.56%)
|
2 |
2/354 (0.56%)
|
2 |
Vaginal pain |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
2 |
Respiratory, thoracic and mediastinal disorders |
|
|
Adult respiratory distress syndrome |
1/355 (0.28%)
|
1 |
1/354 (0.28%)
|
1 |
Allergic rhinitis |
3/355 (0.85%)
|
3 |
8/354 (2.26%)
|
14 |
Atelectasis |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
2 |
Bronchopulmonary hemorrhage |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Bronchospasm |
2/355 (0.56%)
|
2 |
2/354 (0.56%)
|
2 |
Cough |
38/355 (10.70%)
|
57 |
41/354 (11.58%)
|
51 |
Dyspnea |
28/355 (7.89%)
|
33 |
29/354 (8.19%)
|
30 |
Epistaxis |
55/355 (15.49%)
|
63 |
46/354 (12.99%)
|
62 |
Hypoxia |
9/355 (2.54%)
|
9 |
11/354 (3.11%)
|
11 |
Laryngeal edema |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Laryngeal mucositis |
1/355 (0.28%)
|
1 |
2/354 (0.56%)
|
3 |
Laryngeal pain |
2/355 (0.56%)
|
2 |
1/354 (0.28%)
|
1 |
Laryngoscopy abnormal |
2/355 (0.56%)
|
2 |
1/354 (0.28%)
|
2 |
Nasal congestion |
4/355 (1.13%)
|
4 |
4/354 (1.13%)
|
6 |
Pharyngeal examination abnormal |
2/355 (0.56%)
|
2 |
6/354 (1.69%)
|
6 |
Pharyngeal mucositis |
4/355 (1.13%)
|
4 |
1/354 (0.28%)
|
1 |
Pharyngeal stenosis |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Pharyngolaryngeal pain |
28/355 (7.89%)
|
35 |
25/354 (7.06%)
|
30 |
Pleural effusion |
9/355 (2.54%)
|
9 |
6/354 (1.69%)
|
6 |
Pneumonitis |
23/355 (6.48%)
|
33 |
33/354 (9.32%)
|
40 |
Pneumothorax |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Pulmonary fibrosis |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Respiratory disorder |
17/355 (4.79%)
|
23 |
21/354 (5.93%)
|
31 |
Voice alteration |
3/355 (0.85%)
|
4 |
1/354 (0.28%)
|
1 |
Skin and subcutaneous tissue disorders |
|
|
Alopecia |
8/355 (2.25%)
|
10 |
6/354 (1.69%)
|
9 |
Decubitus ulcer |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Dry skin |
11/355 (3.10%)
|
13 |
9/354 (2.54%)
|
12 |
Erythema multiforme |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Hand-and-foot syndrome |
8/355 (2.25%)
|
9 |
9/354 (2.54%)
|
11 |
Nail disorder |
1/355 (0.28%)
|
3 |
0/354 (0.00%)
|
0 |
Pain of skin |
3/355 (0.85%)
|
3 |
2/354 (0.56%)
|
2 |
Petechiae |
67/355 (18.87%)
|
89 |
51/354 (14.41%)
|
68 |
Photosensitivity |
3/355 (0.85%)
|
5 |
0/354 (0.00%)
|
0 |
Pruritus |
25/355 (7.04%)
|
31 |
31/354 (8.76%)
|
41 |
Rash acneiform |
2/355 (0.56%)
|
2 |
2/354 (0.56%)
|
2 |
Rash desquamating |
201/355 (56.62%)
|
358 |
200/354 (56.50%)
|
317 |
Skin disorder |
44/355 (12.39%)
|
67 |
42/354 (11.86%)
|
58 |
Skin hyperpigmentation |
1/355 (0.28%)
|
3 |
3/354 (0.85%)
|
4 |
Skin induration |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
2 |
Skin striae |
1/355 (0.28%)
|
1 |
0/354 (0.00%)
|
0 |
Skin ulceration |
5/355 (1.41%)
|
6 |
6/354 (1.69%)
|
8 |
Sweating |
30/355 (8.45%)
|
50 |
19/354 (5.37%)
|
32 |
Urticaria |
6/355 (1.69%)
|
7 |
5/354 (1.41%)
|
5 |
Vascular disorders |
|
|
Flushing |
0/355 (0.00%)
|
0 |
2/354 (0.56%)
|
3 |
Hematoma |
32/355 (9.01%)
|
40 |
34/354 (9.60%)
|
39 |
Hemorrhage |
15/355 (4.23%)
|
22 |
31/354 (8.76%)
|
33 |
Hot flashes |
2/355 (0.56%)
|
4 |
4/354 (1.13%)
|
4 |
Hypertension |
15/355 (4.23%)
|
21 |
13/354 (3.67%)
|
25 |
Hypotension |
32/355 (9.01%)
|
37 |
32/354 (9.04%)
|
36 |
Lymphedema |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Lymphocele |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Phlebitis |
13/355 (3.66%)
|
19 |
15/354 (4.24%)
|
17 |
Thrombosis |
6/355 (1.69%)
|
6 |
3/354 (0.85%)
|
3 |
Vascular disorder |
0/355 (0.00%)
|
0 |
4/354 (1.13%)
|
4 |
Vasculitis |
2/355 (0.56%)
|
2 |
0/354 (0.00%)
|
0 |
Visceral arterial ischemia |
0/355 (0.00%)
|
0 |
1/354 (0.28%)
|
1 |
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA 6
|