Trial Outcomes & Findings for Combination Chemotherapy With or Without Autologous Stem Cell Transplant in Treating Patients With Central Nervous System B-Cell Lymphoma (NCT NCT01511562)
NCT ID: NCT01511562
Last Updated: 2026-01-30
Results Overview
The primary endpoint is to compare the two-year progression-free survival (PFS) of patients treated with the myeloablative consolidation treatment strategy of HDT/ASCT versus those treated with non-myeloablative consolidation chemotherapy with cytarabine and etoposide. PFS time = time from Registration to earliest date of Progression or Death due to any cause, censoring non-progressed and alive patients at the date of last disease status evaluation. Response will be defined using the modified IPCG criteria. Progressive disease is defined as \> 25% increase in contrast-enhancing CNS (brain and spine if latter abnormal at baseline) disease, appearance of any new, measurable (\>/= 10mm) contrast-enhancing disease or recurrent or new ocular or CSF disease.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
113 participants
Primary outcome timeframe
2 years
Results posted on
2026-01-30
Participant Flow
Participant milestones
| Measure |
Arm I
Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo stem cell transplant.\> \> carmustine: Given IV\>
\> thiotepa: Given IV\>
\> stem cell transplant\>
\> G-CSF
|
Arm II
Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo consolidation chemotherapy.\>
\> cytarabine: Given IV\>
\> etoposide: Given IV\>
\> G-CSF
|
|---|---|---|
|
Induction
STARTED
|
54
|
54
|
|
Induction
COMPLETED
|
45
|
40
|
|
Induction
NOT COMPLETED
|
9
|
14
|
|
Consolidation
STARTED
|
38
|
34
|
|
Consolidation
COMPLETED
|
36
|
34
|
|
Consolidation
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Arm I
Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo stem cell transplant.\> \> carmustine: Given IV\>
\> thiotepa: Given IV\>
\> stem cell transplant\>
\> G-CSF
|
Arm II
Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo consolidation chemotherapy.\>
\> cytarabine: Given IV\>
\> etoposide: Given IV\>
\> G-CSF
|
|---|---|---|
|
Induction
Disease Progression
|
3
|
7
|
|
Induction
Death
|
1
|
3
|
|
Induction
Adverse Event
|
2
|
0
|
|
Induction
Withdrawal by Subject
|
0
|
4
|
|
Induction
Other
|
3
|
0
|
|
Consolidation
Withdrawal by Subject
|
1
|
0
|
|
Consolidation
Other
|
1
|
0
|
Baseline Characteristics
Combination Chemotherapy With or Without Autologous Stem Cell Transplant in Treating Patients With Central Nervous System B-Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Arm I
n=54 Participants
Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo stem cell transplant.\> \> carmustine: Given IV\>
\> thiotepa: Given IV\>
\> stem cell transplant\>
\> G-CSF
|
Arm II
n=54 Participants
Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo consolidation chemotherapy.\>
\> cytarabine: Given IV\>
\> etoposide: Given IV\>
\> G-CSF
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.3 years
STANDARD_DEVIATION 10.41 • n=35 Participants
|
59.5 years
STANDARD_DEVIATION 10.76 • n=4328 Participants
|
58.9 years
STANDARD_DEVIATION 10.56 • n=8687 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=35 Participants
|
25 Participants
n=4328 Participants
|
47 Participants
n=8687 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=35 Participants
|
29 Participants
n=4328 Participants
|
61 Participants
n=8687 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=35 Participants
|
2 Participants
n=4328 Participants
|
4 Participants
n=8687 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=35 Participants
|
48 Participants
n=4328 Participants
|
95 Participants
n=8687 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=35 Participants
|
4 Participants
n=4328 Participants
|
9 Participants
n=8687 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=35 Participants
|
1 Participants
n=4328 Participants
|
1 Participants
n=8687 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
1 Participants
n=8687 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=35 Participants
|
1 Participants
n=4328 Participants
|
3 Participants
n=8687 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=35 Participants
|
50 Participants
n=4328 Participants
|
99 Participants
n=8687 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=35 Participants
|
2 Participants
n=4328 Participants
|
4 Participants
n=8687 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=35 Participants
|
54 participants
n=4328 Participants
|
108 participants
n=8687 Participants
|
|
Karnofsky Performance Status (KPS)
30
|
1 Participants
n=35 Participants
|
1 Participants
n=4328 Participants
|
2 Participants
n=8687 Participants
|
|
Karnofsky Performance Status (KPS)
40
|
0 Participants
n=35 Participants
|
2 Participants
n=4328 Participants
|
2 Participants
n=8687 Participants
|
|
Karnofsky Performance Status (KPS)
50
|
4 Participants
n=35 Participants
|
5 Participants
n=4328 Participants
|
9 Participants
n=8687 Participants
|
|
Karnofsky Performance Status (KPS)
60
|
6 Participants
n=35 Participants
|
6 Participants
n=4328 Participants
|
12 Participants
n=8687 Participants
|
|
Karnofsky Performance Status (KPS)
70
|
12 Participants
n=35 Participants
|
15 Participants
n=4328 Participants
|
27 Participants
n=8687 Participants
|
|
Karnofsky Performance Status (KPS)
80
|
13 Participants
n=35 Participants
|
9 Participants
n=4328 Participants
|
22 Participants
n=8687 Participants
|
|
Karnofsky Performance Status (KPS)
90
|
17 Participants
n=35 Participants
|
14 Participants
n=4328 Participants
|
31 Participants
n=8687 Participants
|
|
Karnofsky Performance Status (KPS)
100
|
1 Participants
n=35 Participants
|
2 Participants
n=4328 Participants
|
3 Participants
n=8687 Participants
|
|
Age and KPS Category
Age < 51 years and any KPS status
|
10 Participants
n=35 Participants
|
10 Participants
n=4328 Participants
|
20 Participants
n=8687 Participants
|
|
Age and KPS Category
Age >= 51 years and KPS < 70
|
11 Participants
n=35 Participants
|
12 Participants
n=4328 Participants
|
23 Participants
n=8687 Participants
|
|
Age and KPS Category
Age >= 51 years and KPS >=70
|
33 Participants
n=35 Participants
|
32 Participants
n=4328 Participants
|
65 Participants
n=8687 Participants
|
PRIMARY outcome
Timeframe: 2 yearsThe primary endpoint is to compare the two-year progression-free survival (PFS) of patients treated with the myeloablative consolidation treatment strategy of HDT/ASCT versus those treated with non-myeloablative consolidation chemotherapy with cytarabine and etoposide. PFS time = time from Registration to earliest date of Progression or Death due to any cause, censoring non-progressed and alive patients at the date of last disease status evaluation. Response will be defined using the modified IPCG criteria. Progressive disease is defined as \> 25% increase in contrast-enhancing CNS (brain and spine if latter abnormal at baseline) disease, appearance of any new, measurable (\>/= 10mm) contrast-enhancing disease or recurrent or new ocular or CSF disease.
Outcome measures
| Measure |
Arm I
n=54 Participants
Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo stem cell transplant.
\>
\> carmustine: Given IV
\>
\> thiotepa: Given IV
\>
\> stem cell transplant
\>
\> G-CSF
|
Arm II
n=54 Participants
Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo consolidation chemotherapy.
\>
\> cytarabine: Given IV
\>
\> etoposide: Given IV
\>
\> G-CSF
|
|---|---|---|
|
Progression Free Survival
|
72.9 percentage of participants w/out event
Interval 58.5 to 83.0
|
50.6 percentage of participants w/out event
Interval 36.1 to 63.3
|
SECONDARY outcome
Timeframe: 2 yearsTo compare the two-year event-free survival (EFS) of patients treated with consolidation HDT/ASCT versus those treated with consolidation chemotherapy consisting of etoposide and cytarabine. EFS event = same definition as PFS with non-protocol treatment also considered an event
Outcome measures
| Measure |
Arm I
n=54 Participants
Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo stem cell transplant.
\>
\> carmustine: Given IV
\>
\> thiotepa: Given IV
\>
\> stem cell transplant
\>
\> G-CSF
|
Arm II
n=54 Participants
Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo consolidation chemotherapy.
\>
\> cytarabine: Given IV
\>
\> etoposide: Given IV
\>
\> G-CSF
|
|---|---|---|
|
Event Free Survival
|
65.7 percentage of participants w/out event
Interval 51.2 to 76.9
|
48.5 percentage of participants w/out event
Interval 34.2 to 61.4
|
SECONDARY outcome
Timeframe: 7 yearsNumber of patients reporting at least one adverse event at least possibly related to treatment.
Outcome measures
| Measure |
Arm I
n=54 Participants
Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo stem cell transplant.
\>
\> carmustine: Given IV
\>
\> thiotepa: Given IV
\>
\> stem cell transplant
\>
\> G-CSF
|
Arm II
n=54 Participants
Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo consolidation chemotherapy.
\>
\> cytarabine: Given IV
\>
\> etoposide: Given IV
\>
\> G-CSF
|
|---|---|---|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
|
54 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: 2 yearsTo compare the overall survival (OS) of patients treated with the consolidation HDT/ASCT versus those treated with consolidation chemotherapy consisting of etoposide and cytarabine. OS event = Registration/Randomization to Death due to any cause
Outcome measures
| Measure |
Arm I
n=54 Participants
Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo stem cell transplant.
\>
\> carmustine: Given IV
\>
\> thiotepa: Given IV
\>
\> stem cell transplant
\>
\> G-CSF
|
Arm II
n=54 Participants
Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo consolidation chemotherapy.
\>
\> cytarabine: Given IV
\>
\> etoposide: Given IV
\>
\> G-CSF
|
|---|---|---|
|
Overall Survival
|
86.6 percentage of participants alive
Interval 73.9 to 93.4
|
78.3 percentage of participants alive
Interval 64.3 to 87.4
|
Adverse Events
Arm I
Serious events: 21 serious events
Other events: 54 other events
Deaths: 11 deaths
Arm II
Serious events: 33 serious events
Other events: 53 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
Arm I
n=54 participants at risk
Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo stem cell transplant. \> \> carmustine: Given IV \>
* thiotepa: Given IV \>
* stem cell transplant \>
* G-CSF
|
Arm II
n=54 participants at risk
Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo consolidation chemotherapy. \>
* cytarabine: Given IV \>
* etoposide: Given IV \>
* G-CSF
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.9%
1/54 • Number of events 1 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.6%
3/54 • Number of events 3 • 7 years
|
5.6%
3/54 • Number of events 5 • 7 years
|
|
Cardiac disorders
Acute coronary syndrome
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/54 • 7 years
|
3.7%
2/54 • Number of events 2 • 7 years
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Gastrointestinal disorders
Constipation
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Gastrointestinal disorders
Diarrhea
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
General disorders and administration site conditions
Fatigue
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
General disorders and administration site conditions
Sudden death NOS
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Infections and infestations
Catheter related infection
|
1.9%
1/54 • Number of events 1 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Infections and infestations
Encephalitis infection
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Infections and infestations
Infections and infestations - Oth spec
|
1.9%
1/54 • Number of events 1 • 7 years
|
5.6%
3/54 • Number of events 3 • 7 years
|
|
Infections and infestations
Lung infection
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Infections and infestations
Sepsis
|
1.9%
1/54 • Number of events 1 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Infections and infestations
Wound infection
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Investigations
Alanine aminotransferase increased
|
1.9%
1/54 • Number of events 1 • 7 years
|
9.3%
5/54 • Number of events 6 • 7 years
|
|
Investigations
Alkaline phosphatase increased
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Investigations
Aspartate aminotransferase increased
|
1.9%
1/54 • Number of events 2 • 7 years
|
7.4%
4/54 • Number of events 7 • 7 years
|
|
Investigations
Creatinine increased
|
3.7%
2/54 • Number of events 2 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Investigations
Lymphocyte count decreased
|
1.9%
1/54 • Number of events 1 • 7 years
|
9.3%
5/54 • Number of events 6 • 7 years
|
|
Investigations
Neutrophil count decreased
|
9.3%
5/54 • Number of events 5 • 7 years
|
7.4%
4/54 • Number of events 4 • 7 years
|
|
Investigations
Platelet count decreased
|
3.7%
2/54 • Number of events 2 • 7 years
|
7.4%
4/54 • Number of events 4 • 7 years
|
|
Investigations
White blood cell decreased
|
3.7%
2/54 • Number of events 2 • 7 years
|
3.7%
2/54 • Number of events 2 • 7 years
|
|
Metabolism and nutrition disorders
Anorexia
|
3.7%
2/54 • Number of events 3 • 7 years
|
0.00%
0/54 • 7 years
|
|
Metabolism and nutrition disorders
Dehydration
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/54 • 7 years
|
3.7%
2/54 • Number of events 2 • 7 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/54 • 7 years
|
3.7%
2/54 • Number of events 3 • 7 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/54 • 7 years
|
7.4%
4/54 • Number of events 5 • 7 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.7%
2/54 • Number of events 3 • 7 years
|
0.00%
0/54 • 7 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Nervous system disorders
Edema cerebral
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Nervous system disorders
Muscle weakness left-sided
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
1.9%
1/54 • Number of events 1 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Nervous system disorders
Seizure
|
1.9%
1/54 • Number of events 2 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Nervous system disorders
Somnolence
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Nervous system disorders
Stroke
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Nervous system disorders
Syncope
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/54 • 7 years
|
5.6%
3/54 • Number of events 3 • 7 years
|
|
Psychiatric disorders
Delirium
|
3.7%
2/54 • Number of events 2 • 7 years
|
0.00%
0/54 • 7 years
|
|
Psychiatric disorders
Depression
|
1.9%
1/54 • Number of events 2 • 7 years
|
0.00%
0/54 • 7 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Renal and urinary disorders
Acute kidney injury
|
7.4%
4/54 • Number of events 4 • 7 years
|
5.6%
3/54 • Number of events 3 • 7 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/54 • 7 years
|
3.7%
2/54 • Number of events 2 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.9%
1/54 • Number of events 1 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Vascular disorders
Hematoma
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Vascular disorders
Hypotension
|
3.7%
2/54 • Number of events 2 • 7 years
|
3.7%
2/54 • Number of events 2 • 7 years
|
|
Vascular disorders
Thromboembolic event
|
1.9%
1/54 • Number of events 1 • 7 years
|
3.7%
2/54 • Number of events 2 • 7 years
|
|
General disorders
Gait disturbance
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
Other adverse events
| Measure |
Arm I
n=54 participants at risk
Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo stem cell transplant. \> \> carmustine: Given IV \>
* thiotepa: Given IV \>
* stem cell transplant \>
* G-CSF
|
Arm II
n=54 participants at risk
Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo consolidation chemotherapy. \>
* cytarabine: Given IV \>
* etoposide: Given IV \>
* G-CSF
|
|---|---|---|
|
Investigations
Lymphocyte count decreased
|
57.4%
31/54 • Number of events 161 • 7 years
|
42.6%
23/54 • Number of events 104 • 7 years
|
|
Investigations
Lymphocyte count increased
|
9.3%
5/54 • Number of events 5 • 7 years
|
0.00%
0/54 • 7 years
|
|
Investigations
Neutrophil count decreased
|
85.2%
46/54 • Number of events 144 • 7 years
|
75.9%
41/54 • Number of events 113 • 7 years
|
|
Investigations
Platelet count decreased
|
88.9%
48/54 • Number of events 258 • 7 years
|
90.7%
49/54 • Number of events 182 • 7 years
|
|
Investigations
Urine output decreased
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Investigations
Weight gain
|
1.9%
1/54 • Number of events 7 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Investigations
Weight loss
|
14.8%
8/54 • Number of events 15 • 7 years
|
3.7%
2/54 • Number of events 4 • 7 years
|
|
Investigations
White blood cell decreased
|
51.9%
28/54 • Number of events 99 • 7 years
|
42.6%
23/54 • Number of events 65 • 7 years
|
|
Metabolism and nutrition disorders
Alkalosis
|
3.7%
2/54 • Number of events 2 • 7 years
|
0.00%
0/54 • 7 years
|
|
Metabolism and nutrition disorders
Anorexia
|
46.3%
25/54 • Number of events 56 • 7 years
|
29.6%
16/54 • Number of events 28 • 7 years
|
|
Metabolism and nutrition disorders
Dehydration
|
9.3%
5/54 • Number of events 8 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
1.9%
1/54 • Number of events 2 • 7 years
|
5.6%
3/54 • Number of events 9 • 7 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.6%
3/54 • Number of events 3 • 7 years
|
3.7%
2/54 • Number of events 2 • 7 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
42.6%
23/54 • Number of events 64 • 7 years
|
40.7%
22/54 • Number of events 71 • 7 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.4%
4/54 • Number of events 5 • 7 years
|
9.3%
5/54 • Number of events 5 • 7 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
9.3%
5/54 • Number of events 12 • 7 years
|
9.3%
5/54 • Number of events 8 • 7 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
3.7%
2/54 • Number of events 2 • 7 years
|
5.6%
3/54 • Number of events 3 • 7 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
27/54 • Number of events 72 • 7 years
|
35.2%
19/54 • Number of events 46 • 7 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
44.4%
24/54 • Number of events 66 • 7 years
|
33.3%
18/54 • Number of events 50 • 7 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.6%
3/54 • Number of events 3 • 7 years
|
5.6%
3/54 • Number of events 3 • 7 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
51.9%
28/54 • Number of events 88 • 7 years
|
42.6%
23/54 • Number of events 53 • 7 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
16.7%
9/54 • Number of events 17 • 7 years
|
7.4%
4/54 • Number of events 7 • 7 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
14.8%
8/54 • Number of events 11 • 7 years
|
22.2%
12/54 • Number of events 15 • 7 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
25.9%
14/54 • Number of events 22 • 7 years
|
14.8%
8/54 • Number of events 15 • 7 years
|
|
Metabolism and nutrition disorders
Metabolism, nutrition disord - Oth spec
|
3.7%
2/54 • Number of events 3 • 7 years
|
1.9%
1/54 • Number of events 2 • 7 years
|
|
Metabolism and nutrition disorders
Obesity
|
1.9%
1/54 • Number of events 2 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
3/54 • Number of events 3 • 7 years
|
3.7%
2/54 • Number of events 7 • 7 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Musculoskeletal and connective tissue disorders
Avascular necrosis
|
1.9%
1/54 • Number of events 2 • 7 years
|
0.00%
0/54 • 7 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/54 • 7 years
|
3.7%
2/54 • Number of events 2 • 7 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.4%
4/54 • Number of events 4 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
3.7%
2/54 • Number of events 2 • 7 years
|
0.00%
0/54 • 7 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
25.9%
14/54 • Number of events 24 • 7 years
|
11.1%
6/54 • Number of events 9 • 7 years
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.9%
1/54 • Number of events 2 • 7 years
|
7.4%
4/54 • Number of events 4 • 7 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.4%
4/54 • Number of events 6 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.9%
1/54 • Number of events 1 • 7 years
|
5.6%
3/54 • Number of events 3 • 7 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.9%
1/54 • Number of events 2 • 7 years
|
7.4%
4/54 • Number of events 8 • 7 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Nervous system disorders
Ataxia
|
13.0%
7/54 • Number of events 19 • 7 years
|
13.0%
7/54 • Number of events 12 • 7 years
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
1.9%
1/54 • Number of events 2 • 7 years
|
0.00%
0/54 • 7 years
|
|
Nervous system disorders
Cognitive disturbance
|
7.4%
4/54 • Number of events 5 • 7 years
|
0.00%
0/54 • 7 years
|
|
Nervous system disorders
Concentration impairment
|
1.9%
1/54 • Number of events 1 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Nervous system disorders
Depressed level of consciousness
|
7.4%
4/54 • Number of events 8 • 7 years
|
11.1%
6/54 • Number of events 7 • 7 years
|
|
Nervous system disorders
Dizziness
|
20.4%
11/54 • Number of events 14 • 7 years
|
7.4%
4/54 • Number of events 5 • 7 years
|
|
Nervous system disorders
Dysarthria
|
9.3%
5/54 • Number of events 13 • 7 years
|
11.1%
6/54 • Number of events 12 • 7 years
|
|
Nervous system disorders
Dysgeusia
|
16.7%
9/54 • Number of events 15 • 7 years
|
3.7%
2/54 • Number of events 4 • 7 years
|
|
Nervous system disorders
Dysphasia
|
3.7%
2/54 • Number of events 3 • 7 years
|
0.00%
0/54 • 7 years
|
|
Nervous system disorders
Encephalopathy
|
1.9%
1/54 • Number of events 1 • 7 years
|
3.7%
2/54 • Number of events 2 • 7 years
|
|
Nervous system disorders
Facial muscle weakness
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Nervous system disorders
Headache
|
35.2%
19/54 • Number of events 36 • 7 years
|
25.9%
14/54 • Number of events 31 • 7 years
|
|
Nervous system disorders
Hydrocephalus
|
1.9%
1/54 • Number of events 3 • 7 years
|
0.00%
0/54 • 7 years
|
|
Nervous system disorders
Hypersomnia
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Nervous system disorders
Lethargy
|
3.7%
2/54 • Number of events 3 • 7 years
|
0.00%
0/54 • 7 years
|
|
Nervous system disorders
Memory impairment
|
16.7%
9/54 • Number of events 15 • 7 years
|
14.8%
8/54 • Number of events 12 • 7 years
|
|
Nervous system disorders
Muscle weakness left-sided
|
1.9%
1/54 • Number of events 4 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
11.1%
6/54 • Number of events 6 • 7 years
|
0.00%
0/54 • 7 years
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Nervous system disorders
Paresthesia
|
7.4%
4/54 • Number of events 6 • 7 years
|
3.7%
2/54 • Number of events 5 • 7 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.7%
2/54 • Number of events 4 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.4%
4/54 • Number of events 11 • 7 years
|
9.3%
5/54 • Number of events 8 • 7 years
|
|
Nervous system disorders
Presyncope
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Nervous system disorders
Seizure
|
7.4%
4/54 • Number of events 5 • 7 years
|
7.4%
4/54 • Number of events 5 • 7 years
|
|
Nervous system disorders
Somnolence
|
3.7%
2/54 • Number of events 2 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Nervous system disorders
Spasticity
|
1.9%
1/54 • Number of events 3 • 7 years
|
0.00%
0/54 • 7 years
|
|
Nervous system disorders
Syncope
|
3.7%
2/54 • Number of events 3 • 7 years
|
0.00%
0/54 • 7 years
|
|
Nervous system disorders
Tremor
|
5.6%
3/54 • Number of events 3 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Psychiatric disorders
Agitation
|
5.6%
3/54 • Number of events 3 • 7 years
|
5.6%
3/54 • Number of events 6 • 7 years
|
|
Psychiatric disorders
Anxiety
|
7.4%
4/54 • Number of events 8 • 7 years
|
7.4%
4/54 • Number of events 8 • 7 years
|
|
Psychiatric disorders
Confusion
|
29.6%
16/54 • Number of events 33 • 7 years
|
33.3%
18/54 • Number of events 40 • 7 years
|
|
Psychiatric disorders
Delirium
|
3.7%
2/54 • Number of events 2 • 7 years
|
3.7%
2/54 • Number of events 2 • 7 years
|
|
Psychiatric disorders
Delusions
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Psychiatric disorders
Depression
|
7.4%
4/54 • Number of events 9 • 7 years
|
5.6%
3/54 • Number of events 3 • 7 years
|
|
Psychiatric disorders
Hallucinations
|
1.9%
1/54 • Number of events 2 • 7 years
|
3.7%
2/54 • Number of events 2 • 7 years
|
|
Psychiatric disorders
Insomnia
|
16.7%
9/54 • Number of events 14 • 7 years
|
16.7%
9/54 • Number of events 22 • 7 years
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/54 • 7 years
|
3.7%
2/54 • Number of events 2 • 7 years
|
|
Renal and urinary disorders
Acute kidney injury
|
14.8%
8/54 • Number of events 15 • 7 years
|
9.3%
5/54 • Number of events 12 • 7 years
|
|
Renal and urinary disorders
Chronic kidney disease
|
3.7%
2/54 • Number of events 7 • 7 years
|
0.00%
0/54 • 7 years
|
|
Renal and urinary disorders
Hematuria
|
3.7%
2/54 • Number of events 2 • 7 years
|
3.7%
2/54 • Number of events 2 • 7 years
|
|
Renal and urinary disorders
Proteinuria
|
3.7%
2/54 • Number of events 4 • 7 years
|
0.00%
0/54 • 7 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
3.7%
2/54 • Number of events 2 • 7 years
|
3.7%
2/54 • Number of events 7 • 7 years
|
|
Renal and urinary disorders
Urinary frequency
|
3.7%
2/54 • Number of events 5 • 7 years
|
0.00%
0/54 • 7 years
|
|
Renal and urinary disorders
Urinary incontinence
|
1.9%
1/54 • Number of events 1 • 7 years
|
3.7%
2/54 • Number of events 2 • 7 years
|
|
Renal and urinary disorders
Urinary retention
|
1.9%
1/54 • Number of events 2 • 7 years
|
3.7%
2/54 • Number of events 2 • 7 years
|
|
Renal and urinary disorders
Urinary urgency
|
1.9%
1/54 • Number of events 1 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Reproductive system and breast disorders
Menorrhagia
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Reproductive system and breast disorders
Reproductive system and breast -Oth spec
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
1.9%
1/54 • Number of events 1 • 7 years
|
3.7%
2/54 • Number of events 3 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
3.7%
2/54 • Number of events 2 • 7 years
|
0.00%
0/54 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.8%
8/54 • Number of events 9 • 7 years
|
16.7%
9/54 • Number of events 11 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
6/54 • Number of events 10 • 7 years
|
13.0%
7/54 • Number of events 11 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.7%
2/54 • Number of events 4 • 7 years
|
5.6%
3/54 • Number of events 3 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 2 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
1.9%
1/54 • Number of events 3 • 7 years
|
3.7%
2/54 • Number of events 2 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
1.9%
1/54 • Number of events 2 • 7 years
|
0.00%
0/54 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.3%
5/54 • Number of events 6 • 7 years
|
11.1%
6/54 • Number of events 8 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.7%
2/54 • Number of events 2 • 7 years
|
0.00%
0/54 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.9%
1/54 • Number of events 1 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/54 • 7 years
|
3.7%
2/54 • Number of events 2 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
3.7%
2/54 • Number of events 10 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
7.4%
4/54 • Number of events 4 • 7 years
|
13.0%
7/54 • Number of events 10 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.6%
3/54 • Number of events 3 • 7 years
|
3.7%
2/54 • Number of events 2 • 7 years
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.7%
2/54 • Number of events 4 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 2 • 7 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.9%
1/54 • Number of events 2 • 7 years
|
0.00%
0/54 • 7 years
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
3.7%
2/54 • Number of events 2 • 7 years
|
0.00%
0/54 • 7 years
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.4%
4/54 • Number of events 6 • 7 years
|
3.7%
2/54 • Number of events 3 • 7 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 2 • 7 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.8%
8/54 • Number of events 10 • 7 years
|
9.3%
5/54 • Number of events 7 • 7 years
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 2 • 7 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
7.4%
4/54 • Number of events 5 • 7 years
|
5.6%
3/54 • Number of events 5 • 7 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 2 • 7 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
3.7%
2/54 • Number of events 2 • 7 years
|
0.00%
0/54 • 7 years
|
|
Surgical and medical procedures
Surgical and medical proced - Oth spec
|
1.9%
1/54 • Number of events 2 • 7 years
|
0.00%
0/54 • 7 years
|
|
Vascular disorders
Flushing
|
5.6%
3/54 • Number of events 3 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Vascular disorders
Hot flashes
|
1.9%
1/54 • Number of events 1 • 7 years
|
1.9%
1/54 • Number of events 2 • 7 years
|
|
Vascular disorders
Hypertension
|
24.1%
13/54 • Number of events 47 • 7 years
|
27.8%
15/54 • Number of events 30 • 7 years
|
|
Vascular disorders
Hypotension
|
14.8%
8/54 • Number of events 9 • 7 years
|
3.7%
2/54 • Number of events 2 • 7 years
|
|
Vascular disorders
Superficial thrombophlebitis
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Vascular disorders
Thromboembolic event
|
7.4%
4/54 • Number of events 10 • 7 years
|
7.4%
4/54 • Number of events 9 • 7 years
|
|
Eye disorders
Glaucoma
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Eye disorders
Night blindness
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Eye disorders
Photophobia
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Eye disorders
Uveitis
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Eye disorders
Watering eyes
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Gastrointestinal disorders
Abdominal distension
|
3.7%
2/54 • Number of events 3 • 7 years
|
0.00%
0/54 • 7 years
|
|
Gastrointestinal disorders
Abdominal pain
|
7.4%
4/54 • Number of events 7 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Gastrointestinal disorders
Bloating
|
3.7%
2/54 • Number of events 2 • 7 years
|
3.7%
2/54 • Number of events 3 • 7 years
|
|
Gastrointestinal disorders
Colitis
|
3.7%
2/54 • Number of events 3 • 7 years
|
0.00%
0/54 • 7 years
|
|
Gastrointestinal disorders
Constipation
|
31.5%
17/54 • Number of events 33 • 7 years
|
37.0%
20/54 • Number of events 50 • 7 years
|
|
Gastrointestinal disorders
Dental caries
|
1.9%
1/54 • Number of events 1 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Gastrointestinal disorders
Diarrhea
|
51.9%
28/54 • Number of events 49 • 7 years
|
33.3%
18/54 • Number of events 29 • 7 years
|
|
Gastrointestinal disorders
Dry mouth
|
3.7%
2/54 • Number of events 4 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
9/54 • Number of events 11 • 7 years
|
7.4%
4/54 • Number of events 6 • 7 years
|
|
Gastrointestinal disorders
Dysphagia
|
3.7%
2/54 • Number of events 2 • 7 years
|
0.00%
0/54 • 7 years
|
|
Gastrointestinal disorders
Esophagitis
|
1.9%
1/54 • Number of events 1 • 7 years
|
3.7%
2/54 • Number of events 2 • 7 years
|
|
Gastrointestinal disorders
Fecal incontinence
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
3.7%
2/54 • Number of events 4 • 7 years
|
3.7%
2/54 • Number of events 2 • 7 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
3.7%
2/54 • Number of events 3 • 7 years
|
3.7%
2/54 • Number of events 2 • 7 years
|
|
Gastrointestinal disorders
Mucositis oral
|
57.4%
31/54 • Number of events 47 • 7 years
|
29.6%
16/54 • Number of events 28 • 7 years
|
|
Gastrointestinal disorders
Nausea
|
63.0%
34/54 • Number of events 97 • 7 years
|
37.0%
20/54 • Number of events 53 • 7 years
|
|
Gastrointestinal disorders
Oral pain
|
1.9%
1/54 • Number of events 1 • 7 years
|
3.7%
2/54 • Number of events 2 • 7 years
|
|
Gastrointestinal disorders
Pancreatic duct stenosis
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Gastrointestinal disorders
Rectal pain
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Gastrointestinal disorders
Small intestinal mucositis
|
5.6%
3/54 • Number of events 3 • 7 years
|
0.00%
0/54 • 7 years
|
|
Gastrointestinal disorders
Stomach pain
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Gastrointestinal disorders
Vomiting
|
40.7%
22/54 • Number of events 42 • 7 years
|
31.5%
17/54 • Number of events 25 • 7 years
|
|
General disorders and administration site conditions
Chills
|
13.0%
7/54 • Number of events 7 • 7 years
|
5.6%
3/54 • Number of events 5 • 7 years
|
|
General disorders and administration site conditions
Death NOS
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
General disorders and administration site conditions
Edema face
|
0.00%
0/54 • 7 years
|
3.7%
2/54 • Number of events 2 • 7 years
|
|
General disorders and administration site conditions
Edema limbs
|
24.1%
13/54 • Number of events 29 • 7 years
|
24.1%
13/54 • Number of events 27 • 7 years
|
|
General disorders and administration site conditions
Fatigue
|
70.4%
38/54 • Number of events 125 • 7 years
|
50.0%
27/54 • Number of events 94 • 7 years
|
|
General disorders and administration site conditions
Fever
|
11.1%
6/54 • Number of events 7 • 7 years
|
11.1%
6/54 • Number of events 7 • 7 years
|
|
Investigations
Aspartate aminotransferase increased
|
85.2%
46/54 • Number of events 153 • 7 years
|
87.0%
47/54 • Number of events 167 • 7 years
|
|
General disorders and administration site conditions
Gait disturbance
|
40.7%
22/54 • Number of events 77 • 7 years
|
38.9%
21/54 • Number of events 60 • 7 years
|
|
Investigations
Blood bilirubin increased
|
53.7%
29/54 • Number of events 75 • 7 years
|
51.9%
28/54 • Number of events 61 • 7 years
|
|
General disorders and administration site conditions
Gen disord and admin site conds-Oth spec
|
3.7%
2/54 • Number of events 7 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
General disorders and administration site conditions
Infusion site extravasation
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Investigations
CD4 lymphocytes decreased
|
3.7%
2/54 • Number of events 2 • 7 years
|
0.00%
0/54 • 7 years
|
|
Investigations
Creatinine increased
|
64.8%
35/54 • Number of events 125 • 7 years
|
44.4%
24/54 • Number of events 55 • 7 years
|
|
General disorders and administration site conditions
Injection site reaction
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Investigations
Ejection fraction decreased
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
General disorders and administration site conditions
Localized edema
|
1.9%
1/54 • Number of events 3 • 7 years
|
5.6%
3/54 • Number of events 7 • 7 years
|
|
Investigations
INR increased
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
General disorders and administration site conditions
Malaise
|
3.7%
2/54 • Number of events 2 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
General disorders and administration site conditions
Neck edema
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
General disorders and administration site conditions
Non-cardiac chest pain
|
5.6%
3/54 • Number of events 3 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Investigations
Investigations - Other, specify
|
7.4%
4/54 • Number of events 10 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
General disorders and administration site conditions
Pain
|
3.7%
2/54 • Number of events 3 • 7 years
|
0.00%
0/54 • 7 years
|
|
Immune system disorders
Allergic reaction
|
3.7%
2/54 • Number of events 2 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Infections and infestations
Bronchial infection
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Infections and infestations
Catheter related infection
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Infections and infestations
Conjunctivitis
|
3.7%
2/54 • Number of events 2 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Infections and infestations
Enterocolitis infectious
|
1.9%
1/54 • Number of events 3 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Infections and infestations
Infections and infestations - Oth spec
|
13.0%
7/54 • Number of events 7 • 7 years
|
5.6%
3/54 • Number of events 3 • 7 years
|
|
Infections and infestations
Lip infection
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Infections and infestations
Lung infection
|
3.7%
2/54 • Number of events 2 • 7 years
|
3.7%
2/54 • Number of events 2 • 7 years
|
|
Infections and infestations
Meningitis
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Infections and infestations
Mucosal infection
|
5.6%
3/54 • Number of events 4 • 7 years
|
5.6%
3/54 • Number of events 6 • 7 years
|
|
Infections and infestations
Otitis externa
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Infections and infestations
Papulopustular rash
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Infections and infestations
Rash pustular
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Infections and infestations
Sepsis
|
3.7%
2/54 • Number of events 3 • 7 years
|
0.00%
0/54 • 7 years
|
|
Infections and infestations
Sinusitis
|
0.00%
0/54 • 7 years
|
3.7%
2/54 • Number of events 2 • 7 years
|
|
Infections and infestations
Skin infection
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 2 • 7 years
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/54 • 7 years
|
3.7%
2/54 • Number of events 2 • 7 years
|
|
Infections and infestations
Upper respiratory infection
|
5.6%
3/54 • Number of events 3 • 7 years
|
3.7%
2/54 • Number of events 2 • 7 years
|
|
Infections and infestations
Urinary tract infection
|
3.7%
2/54 • Number of events 3 • 7 years
|
9.3%
5/54 • Number of events 7 • 7 years
|
|
Injury, poisoning and procedural complications
Bruising
|
1.9%
1/54 • Number of events 1 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Injury, poisoning and procedural complications
Fall
|
14.8%
8/54 • Number of events 9 • 7 years
|
5.6%
3/54 • Number of events 3 • 7 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
13.0%
7/54 • Number of events 8 • 7 years
|
9.3%
5/54 • Number of events 5 • 7 years
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Investigations
Activated partial throm time prolonged
|
3.7%
2/54 • Number of events 2 • 7 years
|
3.7%
2/54 • Number of events 4 • 7 years
|
|
Investigations
Alanine aminotransferase increased
|
87.0%
47/54 • Number of events 171 • 7 years
|
87.0%
47/54 • Number of events 177 • 7 years
|
|
Investigations
Alkaline phosphatase increased
|
24.1%
13/54 • Number of events 27 • 7 years
|
14.8%
8/54 • Number of events 13 • 7 years
|
|
Eye disorders
Dry eye
|
3.7%
2/54 • Number of events 3 • 7 years
|
1.9%
1/54 • Number of events 2 • 7 years
|
|
Eye disorders
Eye disorders - Other, specify
|
1.9%
1/54 • Number of events 3 • 7 years
|
3.7%
2/54 • Number of events 3 • 7 years
|
|
Eye disorders
Flashing lights
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Eye disorders
Floaters
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Blood and lymphatic system disorders
Anemia
|
98.1%
53/54 • Number of events 381 • 7 years
|
88.9%
48/54 • Number of events 233 • 7 years
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
16.7%
9/54 • Number of events 13 • 7 years
|
1.9%
1/54 • Number of events 10 • 7 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
40.7%
22/54 • Number of events 26 • 7 years
|
27.8%
15/54 • Number of events 17 • 7 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
7.4%
4/54 • Number of events 5 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Cardiac disorders
Acute coronary syndrome
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Cardiac disorders
Atrial fibrillation
|
5.6%
3/54 • Number of events 3 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Cardiac disorders
Chest pain - cardiac
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Cardiac disorders
Palpitations
|
1.9%
1/54 • Number of events 2 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Cardiac disorders
Paroxysmal atrial tachycardia
|
1.9%
1/54 • Number of events 1 • 7 years
|
0.00%
0/54 • 7 years
|
|
Cardiac disorders
Sinus bradycardia
|
3.7%
2/54 • Number of events 5 • 7 years
|
3.7%
2/54 • Number of events 2 • 7 years
|
|
Cardiac disorders
Sinus tachycardia
|
9.3%
5/54 • Number of events 14 • 7 years
|
13.0%
7/54 • Number of events 10 • 7 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Ear and labyrinth disorders
Hearing impaired
|
5.6%
3/54 • Number of events 4 • 7 years
|
1.9%
1/54 • Number of events 9 • 7 years
|
|
Ear and labyrinth disorders
Vertigo
|
5.6%
3/54 • Number of events 3 • 7 years
|
1.9%
1/54 • Number of events 1 • 7 years
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 2 • 7 years
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/54 • 7 years
|
1.9%
1/54 • Number of events 2 • 7 years
|
|
Eye disorders
Blurred vision
|
11.1%
6/54 • Number of events 12 • 7 years
|
9.3%
5/54 • Number of events 7 • 7 years
|
|
Eye disorders
Cataract
|
3.7%
2/54 • Number of events 2 • 7 years
|
0.00%
0/54 • 7 years
|
Additional Information
Tracy Batchelor, MD, MPH
Massachusetts General Hospital
Phone: 617-643-1938
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place