Time Frame |
While patients were on protocol therapy (including up to 4 courses, stem cell transplant course, and 3 courses of maintenance therapy)) or up to 7 years in follow-up.
|
Adverse Event Reporting Description |
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
|
Arm/Group Title
|
Arm A
|
Arm B
|
Arm C (Cohort 1)
|
Arm C (Cohort 2)
|
Arm C (Cohort 3)
|
Arm D
|
Arm/Group Description |
INDUCTION (IND) 1Pts receive intrat...
|
IND I: Pts receive cytarabine IT an...
|
IND II: Pts receive cytarabine IT o...
|
IND I: Pts receive cytarabine IT & ...
|
IND I: Pts receive cytarabine IT & ...
|
INDUCTION I: Patients with unknown ...
|
Arm/Group Description |
INDUCTION (IND) 1Pts receive intrathecal (IT) cytarabine on day 1 and ADE with IV cytarabine over 1-30 minutes on days 1-10; daunorubicin hydrochloride IV over 1-15 minutes days1, 3, 5; etoposide IV 1-2 hours days1-5.
IND IILow risk (LR) pts receive cytarabine IT and ADE chemotherapy as in INDI. High risk (HR) cytarabine IT day 1, MA chemo comprising high-dose cytarabine IV over 1-3 hours days1-4, mitoxantrone IV over 15-30 minutes days 3-6. INTENSIFICATION (INT) I: cytarabine IT day 1, AE chemo with high-dose cytarabine IV over 1-3 hours, etoposide IV over 1-2 hours days 1-5. INT II: LR-cytarabine IT day 1; Induction II MA chemo. HR and no SCT donor - high-dose cytarabine IV over 3 hours days1, 2, 8, 9; asparaginase intramuscularly (IM) days2,9.
SCT:
: pts receive fludarabine phosphate IV over 30 minutes once daily days -5 to -2, busulfan IV over 2 hours 4 times daily days -5 to -2.
Allogeneic SCT within 36 to 48 hours after last busulfan dose. Pts receive GVHD prophylaxis.
|
IND I: Pts receive cytarabine IT and ADE chemotherapy as in Induction I, Arm A. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8.
IND II: LR pts receive cytarabine IT, ADE chemotherapy, bortezomib as in IND I. HR pts receive cytarabine IT, MA as in IND II, Arm A (HR patients) and bortezomib IV on days 1, 4, 8.
INT I: Pts receive cytarabine IT and AE in Arm A, Intensification II, and bortezomib IV on days 1, 4, 8. INT II: LR pts receive cytarabine IT on day 1, MA as in Arm A, IND II (HR patients), and bortezomib IV on days 1, 4, 8. HR pts with no donor for SCT receive high-dose cytarabine IV over 3 hours on days 1, 2, 8, 9 and asparaginase intramuscularly (IM) on days 2 and 9.
SCT - Pts receive fludarabine phosphate IV over 30 minutes once daily on days -5 to -2 and busulfan IV over 2 hours 4 times daily on days -5 to -2.Pts undergo allogeneic SCT within 36 to 48 hours after the last dose of busulfan. Pts receive GVHD prophylaxis.
|
IND II: Pts receive cytarabine IT on day 1, cytarabine IV over 1-30 minutes on days 1-8, daunorubicin hydrochloride IV over 1-15 minutes on days 1, 3, and 5, etoposide IV over 1-2 hours on days 1-5, sorafenib tosylate PO on days 9-36.
INT I: Pts receive cytarabine IT and AE chemotherapy in Arm A, Intensification II, and sorafenib tosylate PO on daily on days 6-28.
INT II: Pts receive cytarabine IT on day 1, MA chemotherapy as in Arm A, Induction II (HR patients), sorafenib tosylate PO on days 7-34.
SCT (HR patients with matched family [MFD] or unrelated donor):
Pts receive fludarabine phosphate IV over 30 minutes once daily on days -5 to -2, busulfan IV over 2 hours 4 times daily on days -5 to -2.
Patients undergo allogeneic SCT within 36 to 48 hours after the last dose of busulfan. Pts receive GVHD prophylaxis.
MAINTENANCE: Pts receive sorafenib tosylate PO starting day 40-100 after INT II or SCT for one year.
|
IND I: Pts receive cytarabine IT & ADE as in Arm A, IND I & sorafenib tosylate PO at the time of known HR FLT3/ITD+ (including IND I & concurrently with chemo).
IND II: Pts receive cytarabine IT day (d) 1, cytarabine IV over 1-30 minutes on d 1-8, daunorubicin hydrochloride IV over 1-15 minutes days 1, 3, 5, etoposide IV over 1-2 hours d 1-5, sorafenib tosylate PO d 9-36.
INTE I: Pts receive cytarabine IT and AE in Arm A, INT II, and sorafenib tosylate PO on daily d 6-28.
INT II: Pts receive cytarabine IT on d 1, MA as in Arm A, IND II (HR pts), sorafenib tosylate PO d 7-34.
SCT (HR patients with matched family [MFD] or unrelated donor):
Pts receive fludarabine phosphate IV over 30 minutes once daily on d -5 to -2, busulfan IV over 2 hours 4 times daily d -5 to -2.
Pts undergo allogeneic SCT within 36-48 hours after last busulfan dose. Pts receive GVHD prophylaxis. MAINTENANCE: Pts receive sorafenib tosylate PO starting d 40-100 after INT II or SCT for 1 year.
|
IND I: Pts receive cytarabine IT & ADE as in Arm A, IND I & sorafenib tosylate PO days 11-28.
IND II: Pts receive cytarabine IT day 1, cytarabine IV over 1-30 minutes on days 1-8, daunorubicin hydrochloride IV over 1-15 minutes days 1, 3, 5, etoposide IV over 1-2 hours days 1-5, sorafenib tosylate PO days 9-36.
INT I: Pts receive cytarabine IT & AE cin Arm A, INT II, & sorafenib tosylate PO daily days 6-28.
INT II: Pts receive cytarabine IT day 1, MA as in Arm A, IND II (HR patients), & sorafenib tosylate PO days 7-34.
SCT (HR patients with matched family [MFD] or unrelated donor):
Pts receive fludarabine phosphate IV over 30 minutes once daily on days -5 to -2 and busulfan IV over 2 hours 4 times daily days -5 to -2.
Pts undergo allogeneic SCT within 36 to 48 hours after last busulfan dose. Pts receive GVHD prophylaxis. MAINTENANCE: Pts receive sorafenib tosylate PO starting day 40-100 after INT II or SCT for 1 year.
|
INDUCTION I: Patients with unknown FLT3/ITD status prior to study enrollment receive cytarabine IT and ADE chemotherapy as in Arm A, Induction I. If patients are determined to be HR FLT3/ITD+ no later than the end of Induction I they will be eligible to participate in Arm C.
|
|
|
Arm A
|
Arm B
|
Arm C (Cohort 1)
|
Arm C (Cohort 2)
|
Arm C (Cohort 3)
|
Arm D
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
198/559 (35.42%) |
189/575 (32.87%) |
7/12 (58.33%) |
11/33 (33.33%) |
16/47 (34.04%) |
2/376 (0.53%) |
|
|
Arm A
|
Arm B
|
Arm C (Cohort 1)
|
Arm C (Cohort 2)
|
Arm C (Cohort 3)
|
Arm D
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
82/559 (14.67%) |
305/575 (53.04%) |
6/12 (50.00%) |
16/33 (48.48%) |
30/47 (63.83%) |
2/376 (0.53%) |
Blood and lymphatic system disorders |
|
|
|
|
|
|
Anemia |
0/559 (0.00%) |
3/575 (0.52%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Blood and lymphatic system disorders - Other, specify |
1/559 (0.18%) |
4/575 (0.70%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Bone marrow hypocellular |
0/559 (0.00%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Disseminated intravascular coagulation |
3/559 (0.54%) |
3/575 (0.52%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Febrile neutropenia |
0/559 (0.00%) |
21/575 (3.65%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Hemolysis |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Hemolytic uremic syndrome |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Leukocytosis |
0/559 (0.00%) |
3/575 (0.52%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Cardiac disorders |
|
|
|
|
|
|
Asystole |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Atrial fibrillation |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Atrial flutter |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Cardiac arrest |
3/559 (0.54%) |
4/575 (0.70%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Cardiac disorders - Other, specify |
0/559 (0.00%) |
7/575 (1.22%) |
0/12 (0.00%) |
1/33 (3.03%) |
2/47 (4.26%) |
0/376 (0.00%) |
Chest pain - cardiac |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Heart failure |
4/559 (0.72%) |
15/575 (2.61%) |
0/12 (0.00%) |
1/33 (3.03%) |
2/47 (4.26%) |
0/376 (0.00%) |
Left ventricular systolic dysfunction |
3/559 (0.54%) |
23/575 (4.00%) |
0/12 (0.00%) |
2/33 (6.06%) |
4/47 (8.51%) |
0/376 (0.00%) |
Myocardial infarction |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Pericardial effusion |
0/559 (0.00%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Pericarditis |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Restrictive cardiomyopathy |
0/559 (0.00%) |
4/575 (0.70%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Right ventricular dysfunction |
2/559 (0.36%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Sinus bradycardia |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Sinus tachycardia |
0/559 (0.00%) |
10/575 (1.74%) |
0/12 (0.00%) |
0/33 (0.00%) |
1/47 (2.13%) |
0/376 (0.00%) |
Supraventricular tachycardia |
0/559 (0.00%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Ventricular arrhythmia |
0/559 (0.00%) |
3/575 (0.52%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Ventricular fibrillation |
1/559 (0.18%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Ventricular tachycardia |
0/559 (0.00%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Endocrine disorders |
|
|
|
|
|
|
Adrenal insufficiency |
0/559 (0.00%) |
3/575 (0.52%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Endocrine disorders - Other, specify |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Hypothyroidism |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Eye disorders |
|
|
|
|
|
|
Eye disorders - Other, specify |
1/559 (0.18%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Optic nerve disorder |
0/559 (0.00%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
1/47 (2.13%) |
0/376 (0.00%) |
Papilledema |
0/559 (0.00%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
1/47 (2.13%) |
0/376 (0.00%) |
Gastrointestinal disorders |
|
|
|
|
|
|
Abdominal distension |
0/559 (0.00%) |
2/575 (0.35%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Abdominal pain |
0/559 (0.00%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Anal pain |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Ascites |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Colitis |
0/559 (0.00%) |
9/575 (1.57%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Colonic perforation |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Diarrhea |
0/559 (0.00%) |
9/575 (1.57%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Enterocolitis |
0/559 (0.00%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Esophagitis |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Gastric hemorrhage |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Gastritis |
0/559 (0.00%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Gastrointestinal disorders - Other, specify |
0/559 (0.00%) |
3/575 (0.52%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Ileus |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
1/33 (3.03%) |
1/47 (2.13%) |
0/376 (0.00%) |
Lower gastrointestinal hemorrhage |
0/559 (0.00%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
1/47 (2.13%) |
0/376 (0.00%) |
Mucositis oral |
0/559 (0.00%) |
3/575 (0.52%) |
1/12 (8.33%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Nausea |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Oral pain |
0/559 (0.00%) |
2/575 (0.35%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Pancreatitis |
0/559 (0.00%) |
8/575 (1.39%) |
0/12 (0.00%) |
0/33 (0.00%) |
1/47 (2.13%) |
0/376 (0.00%) |
Small intestinal obstruction |
0/559 (0.00%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Typhlitis |
2/559 (0.36%) |
24/575 (4.17%) |
0/12 (0.00%) |
1/33 (3.03%) |
1/47 (2.13%) |
0/376 (0.00%) |
Upper gastrointestinal hemorrhage |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Vomiting |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
General disorders |
|
|
|
|
|
|
Chills |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Death NOS |
38/559 (6.80%) |
35/575 (6.09%) |
1/12 (8.33%) |
5/33 (15.15%) |
6/47 (12.77%) |
0/376 (0.00%) |
Edema face |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Fever |
0/559 (0.00%) |
13/575 (2.26%) |
0/12 (0.00%) |
0/33 (0.00%) |
3/47 (6.38%) |
0/376 (0.00%) |
Gait disturbance |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Hypothermia |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Multi-organ failure |
1/559 (0.18%) |
8/575 (1.39%) |
0/12 (0.00%) |
0/33 (0.00%) |
2/47 (4.26%) |
0/376 (0.00%) |
Non-cardiac chest pain |
0/559 (0.00%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Pain |
0/559 (0.00%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Hepatobiliary disorders |
|
|
|
|
|
|
Bile duct stenosis |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Cholecystitis |
0/559 (0.00%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
1/47 (2.13%) |
0/376 (0.00%) |
Hepatic failure |
2/559 (0.36%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Hepatobiliary disorders - Other, specify |
0/559 (0.00%) |
4/575 (0.70%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Immune system disorders |
|
|
|
|
|
|
Allergic reaction |
1/559 (0.18%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Anaphylaxis |
0/559 (0.00%) |
5/575 (0.87%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Immune system disorders - Other, specify |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Infections and infestations |
|
|
|
|
|
|
Anorectal infection |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Appendicitis |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Bladder infection |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Bronchial infection |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Catheter related infection |
0/559 (0.00%) |
5/575 (0.87%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Cecal infection |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Duodenal infection |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Encephalitis infection |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Enterocolitis infectious |
1/559 (0.18%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Esophageal infection |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
1/47 (2.13%) |
0/376 (0.00%) |
Infections and infestations - Other, specify |
2/559 (0.36%) |
13/575 (2.26%) |
0/12 (0.00%) |
2/33 (6.06%) |
0/47 (0.00%) |
0/376 (0.00%) |
Lung infection |
1/559 (0.18%) |
13/575 (2.26%) |
1/12 (8.33%) |
2/33 (6.06%) |
0/47 (0.00%) |
0/376 (0.00%) |
Lymph gland infection |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Meningitis |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Mucosal infection |
0/559 (0.00%) |
3/575 (0.52%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Periorbital infection |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Sepsis |
17/559 (3.04%) |
50/575 (8.70%) |
0/12 (0.00%) |
1/33 (3.03%) |
4/47 (8.51%) |
0/376 (0.00%) |
Skin infection |
0/559 (0.00%) |
3/575 (0.52%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Soft tissue infection |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Tracheitis |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Upper respiratory infection |
1/559 (0.18%) |
3/575 (0.52%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Urinary tract infection |
1/559 (0.18%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Injury, poisoning and procedural complications |
|
|
|
|
|
|
Infusion related reaction |
0/559 (0.00%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Postoperative hemorrhage |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Vascular access complication |
0/559 (0.00%) |
3/575 (0.52%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Investigations |
|
|
|
|
|
|
Activated partial thromboplastin time prolonged |
0/559 (0.00%) |
4/575 (0.70%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Alanine aminotransferase increased |
0/559 (0.00%) |
16/575 (2.78%) |
0/12 (0.00%) |
0/33 (0.00%) |
2/47 (4.26%) |
0/376 (0.00%) |
Aspartate aminotransferase increased |
1/559 (0.18%) |
10/575 (1.74%) |
0/12 (0.00%) |
0/33 (0.00%) |
1/47 (2.13%) |
0/376 (0.00%) |
Blood bilirubin increased |
2/559 (0.36%) |
16/575 (2.78%) |
0/12 (0.00%) |
1/33 (3.03%) |
1/47 (2.13%) |
0/376 (0.00%) |
Carbon monoxide diffusing capacity decreased |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Creatinine increased |
0/559 (0.00%) |
8/575 (1.39%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Ejection fraction decreased |
2/559 (0.36%) |
18/575 (3.13%) |
0/12 (0.00%) |
2/33 (6.06%) |
4/47 (8.51%) |
0/376 (0.00%) |
Electrocardiogram QT corrected interval prolonged |
1/559 (0.18%) |
3/575 (0.52%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Fibrinogen decreased |
1/559 (0.18%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
GGT increased |
0/559 (0.00%) |
4/575 (0.70%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Investigations - Other, specify |
0/559 (0.00%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
1/47 (2.13%) |
0/376 (0.00%) |
Lipase increased |
0/559 (0.00%) |
4/575 (0.70%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Lymphocyte count decreased |
0/559 (0.00%) |
5/575 (0.87%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Neutrophil count decreased |
0/559 (0.00%) |
8/575 (1.39%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Platelet count decreased |
0/559 (0.00%) |
7/575 (1.22%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Serum amylase increased |
0/559 (0.00%) |
3/575 (0.52%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Urine output decreased |
1/559 (0.18%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Weight loss |
0/559 (0.00%) |
0/575 (0.00%) |
0/12 (0.00%) |
1/33 (3.03%) |
1/47 (2.13%) |
0/376 (0.00%) |
White blood cell decreased |
0/559 (0.00%) |
5/575 (0.87%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Metabolism and nutrition disorders |
|
|
|
|
|
|
Acidosis |
0/559 (0.00%) |
4/575 (0.70%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Alkalosis |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Anorexia |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Dehydration |
0/559 (0.00%) |
3/575 (0.52%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Hypercalcemia |
0/559 (0.00%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Hyperglycemia |
1/559 (0.18%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Hyperkalemia |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
1/47 (2.13%) |
0/376 (0.00%) |
Hypernatremia |
2/559 (0.36%) |
3/575 (0.52%) |
0/12 (0.00%) |
0/33 (0.00%) |
1/47 (2.13%) |
0/376 (0.00%) |
Hypertriglyceridemia |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Hypoalbuminemia |
0/559 (0.00%) |
6/575 (1.04%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Hypocalcemia |
0/559 (0.00%) |
8/575 (1.39%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Hypokalemia |
1/559 (0.18%) |
27/575 (4.70%) |
0/12 (0.00%) |
2/33 (6.06%) |
1/47 (2.13%) |
0/376 (0.00%) |
Hypomagnesemia |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Hyponatremia |
0/559 (0.00%) |
10/575 (1.74%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Hypophosphatemia |
1/559 (0.18%) |
3/575 (0.52%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Metabolism and nutrition disorders - Other, specify |
2/559 (0.36%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Tumor lysis syndrome |
1/559 (0.18%) |
3/575 (0.52%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Musculoskeletal and connective tissue disorders |
|
|
|
|
|
|
Arthralgia |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Back pain |
0/559 (0.00%) |
4/575 (0.70%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Neck pain |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Pain in extremity |
0/559 (0.00%) |
2/575 (0.35%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
|
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify |
2/559 (0.36%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
1/376 (0.27%) |
Nervous system disorders |
|
|
|
|
|
|
Ataxia |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Central nervous system necrosis |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Cerebrospinal fluid leakage |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Cognitive disturbance |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Depressed level of consciousness |
0/559 (0.00%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Dizziness |
0/559 (0.00%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Dysesthesia |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Edema cerebral |
1/559 (0.18%) |
4/575 (0.70%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Encephalopathy |
1/559 (0.18%) |
5/575 (0.87%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Headache |
0/559 (0.00%) |
4/575 (0.70%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Hydrocephalus |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Hypersomnia |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Intracranial hemorrhage |
2/559 (0.36%) |
3/575 (0.52%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
1/376 (0.27%) |
Leukoencephalopathy |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Nervous system disorders - Other, specify |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Neuralgia |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Paresthesia |
0/559 (0.00%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Peripheral sensory neuropathy |
0/559 (0.00%) |
14/575 (2.43%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Reversible posterior leukoencephalopathy syndrome |
0/559 (0.00%) |
4/575 (0.70%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Seizure |
1/559 (0.18%) |
3/575 (0.52%) |
0/12 (0.00%) |
0/33 (0.00%) |
1/47 (2.13%) |
0/376 (0.00%) |
Somnolence |
0/559 (0.00%) |
4/575 (0.70%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Syncope |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Psychiatric disorders |
|
|
|
|
|
|
Agitation |
0/559 (0.00%) |
2/575 (0.35%) |
1/12 (8.33%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Anxiety |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Delirium |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Renal and urinary disorders |
|
|
|
|
|
|
Acute kidney injury |
5/559 (0.89%) |
15/575 (2.61%) |
0/12 (0.00%) |
3/33 (9.09%) |
3/47 (6.38%) |
0/376 (0.00%) |
Cystitis noninfective |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Hematuria |
0/559 (0.00%) |
3/575 (0.52%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Proteinuria |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Renal and urinary disorders - Other, specify |
1/559 (0.18%) |
3/575 (0.52%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Respiratory, thoracic and mediastinal disorders |
|
|
|
|
|
|
Adult respiratory distress syndrome |
3/559 (0.54%) |
15/575 (2.61%) |
0/12 (0.00%) |
2/33 (6.06%) |
0/47 (0.00%) |
0/376 (0.00%) |
Apnea |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Aspiration |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Atelectasis |
0/559 (0.00%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Bronchopulmonary hemorrhage |
3/559 (0.54%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Bronchospasm |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Cough |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Dyspnea |
1/559 (0.18%) |
12/575 (2.09%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Epistaxis |
0/559 (0.00%) |
7/575 (1.22%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Hypoxia |
3/559 (0.54%) |
55/575 (9.57%) |
1/12 (8.33%) |
3/33 (9.09%) |
3/47 (6.38%) |
0/376 (0.00%) |
Laryngeal edema |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Laryngeal mucositis |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Mediastinal hemorrhage |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Pharyngeal mucositis |
0/559 (0.00%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Pleural effusion |
0/559 (0.00%) |
8/575 (1.39%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Pneumonitis |
0/559 (0.00%) |
9/575 (1.57%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Productive cough |
0/559 (0.00%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
1/47 (2.13%) |
0/376 (0.00%) |
Pulmonary edema |
3/559 (0.54%) |
12/575 (2.09%) |
0/12 (0.00%) |
0/33 (0.00%) |
2/47 (4.26%) |
0/376 (0.00%) |
Pulmonary hypertension |
1/559 (0.18%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Respiratory failure |
10/559 (1.79%) |
22/575 (3.83%) |
0/12 (0.00%) |
2/33 (6.06%) |
2/47 (4.26%) |
0/376 (0.00%) |
Respiratory, thoracic and mediastinal disorders - Other, specify |
1/559 (0.18%) |
6/575 (1.04%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Sore throat |
0/559 (0.00%) |
1/575 (0.17%) |
1/12 (8.33%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Stridor |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Tracheal mucositis |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Wheezing |
0/559 (0.00%) |
3/575 (0.52%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Skin and subcutaneous tissue disorders |
|
|
|
|
|
|
Erythroderma |
0/559 (0.00%) |
0/575 (0.00%) |
1/12 (8.33%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Pain of skin |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
1/47 (2.13%) |
0/376 (0.00%) |
Palmar-plantar erythrodysesthesia syndrome |
0/559 (0.00%) |
1/575 (0.17%) |
1/12 (8.33%) |
1/33 (3.03%) |
1/47 (2.13%) |
0/376 (0.00%) |
Pruritus |
0/559 (0.00%) |
1/575 (0.17%) |
1/12 (8.33%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Rash maculo-papular |
0/559 (0.00%) |
10/575 (1.74%) |
1/12 (8.33%) |
2/33 (6.06%) |
3/47 (6.38%) |
0/376 (0.00%) |
Skin and subcutaneous tissue disorders - Other, specify |
0/559 (0.00%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Toxic epidermal necrolysis |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Urticaria |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Vascular disorders |
|
|
|
|
|
|
Capillary leak syndrome |
0/559 (0.00%) |
5/575 (0.87%) |
0/12 (0.00%) |
0/33 (0.00%) |
1/47 (2.13%) |
0/376 (0.00%) |
Flushing |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Hypertension |
0/559 (0.00%) |
10/575 (1.74%) |
0/12 (0.00%) |
1/33 (3.03%) |
1/47 (2.13%) |
0/376 (0.00%) |
Hypotension |
7/559 (1.25%) |
47/575 (8.17%) |
1/12 (8.33%) |
3/33 (9.09%) |
3/47 (6.38%) |
0/376 (0.00%) |
Peripheral ischemia |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Thromboembolic event |
3/559 (0.54%) |
3/575 (0.52%) |
0/12 (0.00%) |
0/33 (0.00%) |
1/47 (2.13%) |
0/376 (0.00%) |
Indicates events were collected by systematic assessment
|
|
Frequency Threshold for Reporting Other Adverse Events
|
0%
|
|
Arm A
|
Arm B
|
Arm C (Cohort 1)
|
Arm C (Cohort 2)
|
Arm C (Cohort 3)
|
Arm D
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
506/559 (90.52%) |
529/575 (92.00%) |
12/12 (100.00%) |
32/33 (96.97%) |
41/47 (87.23%) |
7/376 (1.86%) |
Blood and lymphatic system disorders |
|
|
|
|
|
|
Anemia |
4/559 (0.72%) |
5/575 (0.87%) |
0/12 (0.00%) |
0/33 (0.00%) |
1/47 (2.13%) |
0/376 (0.00%) |
Blood and lymphatic system disorders - Other, specify |
3/559 (0.54%) |
1/575 (0.17%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Bone marrow hypocellular |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Disseminated intravascular coagulation |
3/559 (0.54%) |
3/575 (0.52%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Febrile neutropenia |
212/559 (37.92%) |
175/575 (30.43%) |
6/12 (50.00%) |
8/33 (24.24%) |
12/47 (25.53%) |
2/376 (0.53%) |
Leukocytosis |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Lymph node pain |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Thrombotic thrombocytopenic purpura |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Cardiac disorders |
|
|
|
|
|
|
Asystole |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Cardiac arrest |
4/559 (0.72%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Cardiac disorders - Other, specify |
8/559 (1.43%) |
16/575 (2.78%) |
0/12 (0.00%) |
0/33 (0.00%) |
1/47 (2.13%) |
0/376 (0.00%) |
Chest pain - cardiac |
1/559 (0.18%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Heart failure |
21/559 (3.76%) |
22/575 (3.83%) |
1/12 (8.33%) |
2/33 (6.06%) |
0/47 (0.00%) |
0/376 (0.00%) |
Left ventricular systolic dysfunction |
30/559 (5.37%) |
28/575 (4.87%) |
1/12 (8.33%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Pericardial effusion |
4/559 (0.72%) |
3/575 (0.52%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Pulmonary valve disease |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Restrictive cardiomyopathy |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Right ventricular dysfunction |
3/559 (0.54%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Sinus bradycardia |
1/559 (0.18%) |
3/575 (0.52%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Sinus tachycardia |
13/559 (2.33%) |
7/575 (1.22%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Supraventricular tachycardia |
2/559 (0.36%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Tricuspid valve disease |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Ventricular arrhythmia |
2/559 (0.36%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Ventricular fibrillation |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Ventricular tachycardia |
1/559 (0.18%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Congenital, familial and genetic disorders |
|
|
|
|
|
|
Congenital, familial and genetic disorders - Other, specify |
0/559 (0.00%) |
0/575 (0.00%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Ear and labyrinth disorders |
|
|
|
|
|
|
Hearing impaired |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Endocrine disorders |
|
|
|
|
|
|
Adrenal insufficiency |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Endocrine disorders - Other, specify |
0/559 (0.00%) |
0/575 (0.00%) |
1/12 (8.33%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Eye disorders |
|
|
|
|
|
|
Blurred vision |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Eye disorders - Other, specify |
0/559 (0.00%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Eye pain |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Periorbital edema |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Vitreous hemorrhage |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Gastrointestinal disorders |
|
|
|
|
|
|
Abdominal distension |
3/559 (0.54%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Abdominal pain |
28/559 (5.01%) |
26/575 (4.52%) |
1/12 (8.33%) |
4/33 (12.12%) |
5/47 (10.64%) |
0/376 (0.00%) |
Anal mucositis |
3/559 (0.54%) |
1/575 (0.17%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Anal pain |
7/559 (1.25%) |
4/575 (0.70%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Anal ulcer |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Ascites |
3/559 (0.54%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Colitis |
20/559 (3.58%) |
15/575 (2.61%) |
0/12 (0.00%) |
0/33 (0.00%) |
1/47 (2.13%) |
0/376 (0.00%) |
Constipation |
2/559 (0.36%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Dental caries |
2/559 (0.36%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Diarrhea |
37/559 (6.62%) |
48/575 (8.35%) |
1/12 (8.33%) |
5/33 (15.15%) |
4/47 (8.51%) |
1/376 (0.27%) |
Duodenal ulcer |
0/559 (0.00%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
1/47 (2.13%) |
0/376 (0.00%) |
Dysphagia |
0/559 (0.00%) |
0/575 (0.00%) |
1/12 (8.33%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Enterocolitis |
2/559 (0.36%) |
8/575 (1.39%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Esophageal hemorrhage |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Esophageal pain |
1/559 (0.18%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Esophageal ulcer |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Esophagitis |
4/559 (0.72%) |
2/575 (0.35%) |
1/12 (8.33%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Gastric hemorrhage |
0/559 (0.00%) |
0/575 (0.00%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Gastric ulcer |
0/559 (0.00%) |
0/575 (0.00%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Gastritis |
1/559 (0.18%) |
4/575 (0.70%) |
0/12 (0.00%) |
0/33 (0.00%) |
2/47 (4.26%) |
0/376 (0.00%) |
Gastrointestinal disorders - Other, specify |
2/559 (0.36%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Gastrointestinal fistula |
0/559 (0.00%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
1/47 (2.13%) |
0/376 (0.00%) |
Gastrointestinal pain |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Gingival pain |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Ileal perforation |
0/559 (0.00%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
1/47 (2.13%) |
0/376 (0.00%) |
Ileus |
5/559 (0.89%) |
10/575 (1.74%) |
0/12 (0.00%) |
0/33 (0.00%) |
1/47 (2.13%) |
0/376 (0.00%) |
Lower gastrointestinal hemorrhage |
2/559 (0.36%) |
0/575 (0.00%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Malabsorption |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Mucositis oral |
115/559 (20.57%) |
92/575 (16.00%) |
4/12 (33.33%) |
10/33 (30.30%) |
11/47 (23.40%) |
0/376 (0.00%) |
Nausea |
40/559 (7.16%) |
40/575 (6.96%) |
1/12 (8.33%) |
4/33 (12.12%) |
3/47 (6.38%) |
0/376 (0.00%) |
Oral hemorrhage |
2/559 (0.36%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
1/47 (2.13%) |
0/376 (0.00%) |
Oral pain |
11/559 (1.97%) |
5/575 (0.87%) |
0/12 (0.00%) |
1/33 (3.03%) |
3/47 (6.38%) |
0/376 (0.00%) |
Pancreatitis |
2/559 (0.36%) |
5/575 (0.87%) |
0/12 (0.00%) |
2/33 (6.06%) |
1/47 (2.13%) |
0/376 (0.00%) |
Proctitis |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Rectal mucositis |
2/559 (0.36%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Rectal pain |
7/559 (1.25%) |
4/575 (0.70%) |
0/12 (0.00%) |
0/33 (0.00%) |
1/47 (2.13%) |
0/376 (0.00%) |
Retroperitoneal hemorrhage |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Small intestinal mucositis |
2/559 (0.36%) |
1/575 (0.17%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Small intestinal obstruction |
2/559 (0.36%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Toothache |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Typhlitis |
36/559 (6.44%) |
22/575 (3.83%) |
0/12 (0.00%) |
1/33 (3.03%) |
2/47 (4.26%) |
0/376 (0.00%) |
Upper gastrointestinal hemorrhage |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Vomiting |
21/559 (3.76%) |
23/575 (4.00%) |
0/12 (0.00%) |
4/33 (12.12%) |
2/47 (4.26%) |
1/376 (0.27%) |
General disorders |
|
|
|
|
|
|
Edema face |
2/559 (0.36%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Edema limbs |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Edema trunk |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Fatigue |
4/559 (0.72%) |
3/575 (0.52%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Fever |
53/559 (9.48%) |
94/575 (16.35%) |
2/12 (16.67%) |
5/33 (15.15%) |
7/47 (14.89%) |
0/376 (0.00%) |
General disorders and administration site conditions - Other, specify |
0/559 (0.00%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Localized edema |
2/559 (0.36%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Multi-organ failure |
7/559 (1.25%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Non-cardiac chest pain |
1/559 (0.18%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Pain |
13/559 (2.33%) |
13/575 (2.26%) |
1/12 (8.33%) |
1/33 (3.03%) |
4/47 (8.51%) |
0/376 (0.00%) |
Hepatobiliary disorders |
|
|
|
|
|
|
Cholecystitis |
1/559 (0.18%) |
2/575 (0.35%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Gallbladder necrosis |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Hepatic failure |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Hepatobiliary disorders - Other, specify |
2/559 (0.36%) |
1/575 (0.17%) |
0/12 (0.00%) |
1/33 (3.03%) |
2/47 (4.26%) |
0/376 (0.00%) |
Portal hypertension |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Immune system disorders |
|
|
|
|
|
|
Allergic reaction |
7/559 (1.25%) |
8/575 (1.39%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Anaphylaxis |
10/559 (1.79%) |
4/575 (0.70%) |
0/12 (0.00%) |
2/33 (6.06%) |
0/47 (0.00%) |
0/376 (0.00%) |
Autoimmune disorder |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Immune system disorders - Other, specify |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Serum sickness |
0/559 (0.00%) |
0/575 (0.00%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Infections and infestations |
|
|
|
|
|
|
Abdominal infection |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Anorectal infection |
6/559 (1.07%) |
4/575 (0.70%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Appendicitis |
6/559 (1.07%) |
9/575 (1.57%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Bladder infection |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Bone infection |
5/559 (0.89%) |
1/575 (0.17%) |
1/12 (8.33%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Bronchial infection |
1/559 (0.18%) |
5/575 (0.87%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Catheter related infection |
14/559 (2.50%) |
16/575 (2.78%) |
0/12 (0.00%) |
0/33 (0.00%) |
1/47 (2.13%) |
0/376 (0.00%) |
Cecal infection |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
1/47 (2.13%) |
0/376 (0.00%) |
Conjunctivitis |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Device related infection |
0/559 (0.00%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
1/47 (2.13%) |
0/376 (0.00%) |
Encephalitis infection |
1/559 (0.18%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
1/47 (2.13%) |
0/376 (0.00%) |
Endocarditis infective |
1/559 (0.18%) |
2/575 (0.35%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Endophthalmitis |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Enterocolitis infectious |
31/559 (5.55%) |
29/575 (5.04%) |
0/12 (0.00%) |
2/33 (6.06%) |
1/47 (2.13%) |
1/376 (0.27%) |
Esophageal infection |
2/559 (0.36%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Eye infection |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Gallbladder infection |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Gum infection |
0/559 (0.00%) |
3/575 (0.52%) |
0/12 (0.00%) |
0/33 (0.00%) |
1/47 (2.13%) |
0/376 (0.00%) |
Hepatic infection |
4/559 (0.72%) |
3/575 (0.52%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Hepatitis viral |
1/559 (0.18%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Infections and infestations - Other, specify |
275/559 (49.19%) |
293/575 (50.96%) |
6/12 (50.00%) |
19/33 (57.58%) |
16/47 (34.04%) |
0/376 (0.00%) |
Infective myositis |
4/559 (0.72%) |
1/575 (0.17%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Joint infection |
0/559 (0.00%) |
0/575 (0.00%) |
2/12 (16.67%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Kidney infection |
1/559 (0.18%) |
3/575 (0.52%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Lip infection |
0/559 (0.00%) |
4/575 (0.70%) |
1/12 (8.33%) |
0/33 (0.00%) |
2/47 (4.26%) |
0/376 (0.00%) |
Lung infection |
60/559 (10.73%) |
72/575 (12.52%) |
3/12 (25.00%) |
8/33 (24.24%) |
6/47 (12.77%) |
1/376 (0.27%) |
Lymph gland infection |
2/559 (0.36%) |
7/575 (1.22%) |
0/12 (0.00%) |
1/33 (3.03%) |
1/47 (2.13%) |
0/376 (0.00%) |
Meningitis |
2/559 (0.36%) |
1/575 (0.17%) |
1/12 (8.33%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Mucosal infection |
6/559 (1.07%) |
3/575 (0.52%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Nail infection |
1/559 (0.18%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Otitis externa |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Otitis media |
1/559 (0.18%) |
3/575 (0.52%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Papulopustular rash |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Paronychia |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Pelvic infection |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Penile infection |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Periorbital infection |
2/559 (0.36%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Peritoneal infection |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Pharyngitis |
1/559 (0.18%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Pleural infection |
2/559 (0.36%) |
3/575 (0.52%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Salivary gland infection |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Scrotal infection |
1/559 (0.18%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Sepsis |
88/559 (15.74%) |
72/575 (12.52%) |
0/12 (0.00%) |
3/33 (9.09%) |
3/47 (6.38%) |
1/376 (0.27%) |
Sinusitis |
11/559 (1.97%) |
17/575 (2.96%) |
1/12 (8.33%) |
1/33 (3.03%) |
1/47 (2.13%) |
0/376 (0.00%) |
Skin infection |
36/559 (6.44%) |
26/575 (4.52%) |
1/12 (8.33%) |
0/33 (0.00%) |
3/47 (6.38%) |
0/376 (0.00%) |
Small intestine infection |
1/559 (0.18%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Soft tissue infection |
8/559 (1.43%) |
10/575 (1.74%) |
1/12 (8.33%) |
2/33 (6.06%) |
1/47 (2.13%) |
0/376 (0.00%) |
Splenic infection |
2/559 (0.36%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Tooth infection |
2/559 (0.36%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Tracheitis |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Upper respiratory infection |
13/559 (2.33%) |
24/575 (4.17%) |
1/12 (8.33%) |
0/33 (0.00%) |
1/47 (2.13%) |
0/376 (0.00%) |
Urinary tract infection |
18/559 (3.22%) |
20/575 (3.48%) |
0/12 (0.00%) |
1/33 (3.03%) |
1/47 (2.13%) |
0/376 (0.00%) |
Vaginal infection |
1/559 (0.18%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Vulval infection |
4/559 (0.72%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Wound infection |
1/559 (0.18%) |
3/575 (0.52%) |
0/12 (0.00%) |
0/33 (0.00%) |
1/47 (2.13%) |
0/376 (0.00%) |
Injury, poisoning and procedural complications |
|
|
|
|
|
|
Infusion related reaction |
4/559 (0.72%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Injury, poisoning and procedural complications - Other, specify |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Tracheal obstruction |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
1/47 (2.13%) |
0/376 (0.00%) |
Vascular access complication |
3/559 (0.54%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Venous injury |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Wound dehiscence |
0/559 (0.00%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
1/47 (2.13%) |
0/376 (0.00%) |
Investigations |
|
|
|
|
|
|
Activated partial thromboplastin time prolonged |
6/559 (1.07%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Alanine aminotransferase increased |
84/559 (15.03%) |
79/575 (13.74%) |
0/12 (0.00%) |
7/33 (21.21%) |
14/47 (29.79%) |
2/376 (0.53%) |
Alkaline phosphatase increased |
1/559 (0.18%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Aspartate aminotransferase increased |
56/559 (10.02%) |
63/575 (10.96%) |
0/12 (0.00%) |
5/33 (15.15%) |
7/47 (14.89%) |
1/376 (0.27%) |
Blood bilirubin increased |
25/559 (4.47%) |
20/575 (3.48%) |
1/12 (8.33%) |
3/33 (9.09%) |
5/47 (10.64%) |
0/376 (0.00%) |
CPK increased |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Cardiac troponin I increased |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Cholesterol high |
0/559 (0.00%) |
0/575 (0.00%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Creatinine increased |
1/559 (0.18%) |
10/575 (1.74%) |
1/12 (8.33%) |
0/33 (0.00%) |
1/47 (2.13%) |
0/376 (0.00%) |
Ejection fraction decreased |
22/559 (3.94%) |
29/575 (5.04%) |
1/12 (8.33%) |
4/33 (12.12%) |
0/47 (0.00%) |
0/376 (0.00%) |
Electrocardiogram QT corrected interval prolonged |
153/559 (27.37%) |
175/575 (30.43%) |
3/12 (25.00%) |
10/33 (30.30%) |
14/47 (29.79%) |
0/376 (0.00%) |
Fibrinogen decreased |
1/559 (0.18%) |
3/575 (0.52%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
GGT increased |
16/559 (2.86%) |
19/575 (3.30%) |
0/12 (0.00%) |
3/33 (9.09%) |
1/47 (2.13%) |
0/376 (0.00%) |
INR increased |
1/559 (0.18%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Investigations - Other, specify |
3/559 (0.54%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Lipase increased |
10/559 (1.79%) |
9/575 (1.57%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Neutrophil count decreased |
188/559 (33.63%) |
193/575 (33.57%) |
3/12 (25.00%) |
7/33 (21.21%) |
5/47 (10.64%) |
0/376 (0.00%) |
Platelet count decreased |
4/559 (0.72%) |
7/575 (1.22%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Serum amylase increased |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Urine output decreased |
1/559 (0.18%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Weight gain |
1/559 (0.18%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Weight loss |
12/559 (2.15%) |
7/575 (1.22%) |
0/12 (0.00%) |
2/33 (6.06%) |
0/47 (0.00%) |
0/376 (0.00%) |
White blood cell decreased |
2/559 (0.36%) |
3/575 (0.52%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Metabolism and nutrition disorders |
|
|
|
|
|
|
Acidosis |
5/559 (0.89%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Alkalosis |
5/559 (0.89%) |
3/575 (0.52%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Anorexia |
123/559 (22.00%) |
130/575 (22.61%) |
5/12 (41.67%) |
7/33 (21.21%) |
11/47 (23.40%) |
0/376 (0.00%) |
Dehydration |
12/559 (2.15%) |
6/575 (1.04%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Glucose intolerance |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Hypercalcemia |
2/559 (0.36%) |
5/575 (0.87%) |
0/12 (0.00%) |
0/33 (0.00%) |
1/47 (2.13%) |
0/376 (0.00%) |
Hyperglycemia |
59/559 (10.55%) |
59/575 (10.26%) |
3/12 (25.00%) |
6/33 (18.18%) |
6/47 (12.77%) |
1/376 (0.27%) |
Hyperkalemia |
17/559 (3.04%) |
10/575 (1.74%) |
1/12 (8.33%) |
3/33 (9.09%) |
2/47 (4.26%) |
0/376 (0.00%) |
Hypermagnesemia |
3/559 (0.54%) |
3/575 (0.52%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Hypernatremia |
2/559 (0.36%) |
9/575 (1.57%) |
1/12 (8.33%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Hypertriglyceridemia |
5/559 (0.89%) |
4/575 (0.70%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Hyperuricemia |
1/559 (0.18%) |
1/575 (0.17%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Hypoalbuminemia |
14/559 (2.50%) |
19/575 (3.30%) |
0/12 (0.00%) |
1/33 (3.03%) |
2/47 (4.26%) |
1/376 (0.27%) |
Hypocalcemia |
31/559 (5.55%) |
29/575 (5.04%) |
3/12 (25.00%) |
3/33 (9.09%) |
1/47 (2.13%) |
1/376 (0.27%) |
Hypoglycemia |
1/559 (0.18%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Hypokalemia |
149/559 (26.65%) |
152/575 (26.43%) |
5/12 (41.67%) |
9/33 (27.27%) |
9/47 (19.15%) |
0/376 (0.00%) |
Hypomagnesemia |
5/559 (0.89%) |
4/575 (0.70%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Hyponatremia |
34/559 (6.08%) |
28/575 (4.87%) |
2/12 (16.67%) |
5/33 (15.15%) |
2/47 (4.26%) |
0/376 (0.00%) |
Hypophosphatemia |
39/559 (6.98%) |
42/575 (7.30%) |
1/12 (8.33%) |
3/33 (9.09%) |
7/47 (14.89%) |
0/376 (0.00%) |
Iron overload |
2/559 (0.36%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Metabolism and nutrition disorders - Other, specify |
1/559 (0.18%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Tumor lysis syndrome |
9/559 (1.61%) |
12/575 (2.09%) |
0/12 (0.00%) |
0/33 (0.00%) |
1/47 (2.13%) |
1/376 (0.27%) |
Musculoskeletal and connective tissue disorders |
|
|
|
|
|
|
Arthralgia |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
2/33 (6.06%) |
1/47 (2.13%) |
0/376 (0.00%) |
Avascular necrosis |
0/559 (0.00%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Back pain |
8/559 (1.43%) |
7/575 (1.22%) |
1/12 (8.33%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Bone pain |
2/559 (0.36%) |
1/575 (0.17%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Buttock pain |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
2/47 (4.26%) |
0/376 (0.00%) |
Chest wall pain |
3/559 (0.54%) |
0/575 (0.00%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Flank pain |
2/559 (0.36%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Generalized muscle weakness |
1/559 (0.18%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Musculoskeletal and connective tissue disorder - Other, specify |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Myalgia |
0/559 (0.00%) |
2/575 (0.35%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Myositis |
4/559 (0.72%) |
3/575 (0.52%) |
1/12 (8.33%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Neck pain |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Pain in extremity |
6/559 (1.07%) |
5/575 (0.87%) |
2/12 (16.67%) |
1/33 (3.03%) |
1/47 (2.13%) |
0/376 (0.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
|
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify |
24/559 (4.29%) |
13/575 (2.26%) |
0/12 (0.00%) |
1/33 (3.03%) |
0/47 (0.00%) |
0/376 (0.00%) |
Nervous system disorders |
|
|
|
|
|
|
Aphonia |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Cognitive disturbance |
1/559 (0.18%) |
1/575 (0.17%) |
1/12 (8.33%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Depressed level of consciousness |
2/559 (0.36%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Dizziness |
0/559 (0.00%) |
1/575 (0.17%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Encephalopathy |
1/559 (0.18%) |
0/575 (0.00%) |
0/12 (0.00%) |
0/33 (0.00%) |
0/47 (0.00%) |
0/376 (0.00%) |
Headache |
22/559 (3.94%) |
|