Trial Outcomes & Findings for NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma (NCT NCT01451515)
NCT ID: NCT01451515
Last Updated: 2022-06-28
Results Overview
For EFS, relapse and second malignancies are considered as failures in addition to death in complete remission. The time to EFS will be set to 0 for patients who fail to achieve complete remission. Kaplan-Meier estimates of the OS and EFS curves are computed, along with estimates of standard errors by Peto's method. Please note the unit of measurement of probabilities are percentages.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
Two years post therapy.
Results posted on
2022-06-28
Participant Flow
23 eligible patients were recruited between 23MAY2012 and 06DEC2016
Participant milestones
| Measure |
Stratum 1
Minimal disseminated disease (MDD) \<1% at diagnosis in T-lymphoblastic lymphoma No bone marrow involvement microscopically at diagnosis in B-lymphoblastic lymphoma
Patients should not have:
* Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (\<5 WBC/µL of CSF with blasts) or traumatic LP (\>10 RBC/µL of CSF with blasts)
* Overt testicular involvement (evidenced by ultrasonogram).
|
Stratum 2
* MDD ≥1% and MRD negative (\<0.01%) on day 8 in T-lymphoblastic lymphoma
* Bone marrow involvement microscopically present at diagnosis in B-lymphoblastic lymphoma
* Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (\<5 WBC/µL of CSF with blasts) or traumatic LP (\>10 RBC/µL of CSF with blasts) but does not fulfill the criteria of stratum 3
* Overt testicular involvement (evidenced by ultrasonogram) but does not fulfill the criteria of stratum 3
|
Stratum 3
Any patients with MDD ≥1% and MRD positive (≥0.01%) on day 8 in T-lymphoblastic lymphoma
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
7
|
4
|
|
Overall Study
COMPLETED
|
11
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
1
|
Reasons for withdrawal
| Measure |
Stratum 1
Minimal disseminated disease (MDD) \<1% at diagnosis in T-lymphoblastic lymphoma No bone marrow involvement microscopically at diagnosis in B-lymphoblastic lymphoma
Patients should not have:
* Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (\<5 WBC/µL of CSF with blasts) or traumatic LP (\>10 RBC/µL of CSF with blasts)
* Overt testicular involvement (evidenced by ultrasonogram).
|
Stratum 2
* MDD ≥1% and MRD negative (\<0.01%) on day 8 in T-lymphoblastic lymphoma
* Bone marrow involvement microscopically present at diagnosis in B-lymphoblastic lymphoma
* Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (\<5 WBC/µL of CSF with blasts) or traumatic LP (\>10 RBC/µL of CSF with blasts) but does not fulfill the criteria of stratum 3
* Overt testicular involvement (evidenced by ultrasonogram) but does not fulfill the criteria of stratum 3
|
Stratum 3
Any patients with MDD ≥1% and MRD positive (≥0.01%) on day 8 in T-lymphoblastic lymphoma
|
|---|---|---|---|
|
Overall Study
Death
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
|
Overall Study
Development of unacceptable toxicity during treatment
|
0
|
0
|
1
|
|
Overall Study
Relapse (except CNS)
|
1
|
1
|
0
|
Baseline Characteristics
NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma
Baseline characteristics by cohort
| Measure |
Stratum 1
n=12 Participants
Minimal disseminated disease (MDD) \<1% at diagnosis in T-lymphoblastic lymphoma No bone marrow involvement microscopically at diagnosis in B-lymphoblastic lymphoma
Patients should not have:
* Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (\<5 WBC/µL of CSF with blasts) or traumatic LP (\>10 RBC/µL of CSF with blasts)
* Overt testicular involvement (evidenced by ultrasonogram).
|
Stratum 2
n=7 Participants
* MDD ≥1% and MRD negative (\<0.01%) on day 8 in T-lymphoblastic lymphoma
* Bone marrow involvement microscopically present at diagnosis in B-lymphoblastic lymphoma
* Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (\<5 WBC/µL of CSF with blasts) or traumatic LP (\>10 RBC/µL of CSF with blasts) but does not fulfill the criteria of stratum 3
* Overt testicular involvement (evidenced by ultrasonogram) but does not fulfill the criteria of stratum 3
|
Stratum 3
n=4 Participants
Any patients with MDD ≥1% and MRD positive (≥0.01%) on day 8 in T-lymphoblastic lymphoma
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
13.0 years
n=93 Participants
|
12.3 years
n=4 Participants
|
13.0 years
n=27 Participants
|
12.9 years
n=483 Participants
|
|
Age, Customized
<10 years
|
5 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
|
Age, Customized
>=10 years
|
7 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
15 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Multiple Race (NOS)
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
NOS Spanish,Hispanic,Latino
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Non Spanish speaking, Non Hispanic
|
12 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
22 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Two years post therapy.For EFS, relapse and second malignancies are considered as failures in addition to death in complete remission. The time to EFS will be set to 0 for patients who fail to achieve complete remission. Kaplan-Meier estimates of the OS and EFS curves are computed, along with estimates of standard errors by Peto's method. Please note the unit of measurement of probabilities are percentages.
Outcome measures
| Measure |
Stratum 1
n=12 Participants
Minimal disseminated disease (MDD) \<1% at diagnosis in T-lymphoblastic lymphoma No bone marrow involvement microscopically at diagnosis in B-lymphoblastic lymphoma
Patients should not have:
* Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (\<5 WBC/µL of CSF with blasts) or traumatic LP (\>10 RBC/µL of CSF with blasts)
* Overt testicular involvement (evidenced by ultrasonogram).
|
Stratum 2
n=7 Participants
* MDD ≥1% and MRD negative (\<0.01%) on day 8 in T-lymphoblastic lymphoma
* Bone marrow involvement microscopically present at diagnosis in B-lymphoblastic lymphoma
* Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (\<5 WBC/µL of CSF with blasts) or traumatic LP (\>10 RBC/µL of CSF with blasts) but does not fulfill the criteria of stratum 3
* Overt testicular involvement (evidenced by ultrasonogram) but does not fulfill the criteria of stratum 3
|
Stratum 3
n=4 Participants
Any patients with MDD ≥1% and MRD positive (≥0.01%) on day 8 in T-lymphoblastic lymphoma
|
All Enrollments
n=23 Participants
Twenty-three (23) eligible patients
|
|---|---|---|---|---|
|
Probability of Event-free Survival (EFS)
|
91.7 percentage of event-free patients
Interval 53.9 to 98.8
|
71.4 percentage of event-free patients
Interval 25.8 to 92.0
|
100 percentage of event-free patients
Interval 100.0 to 100.0
|
86.96 percentage of event-free patients
Interval 64.81 to 95.6
|
SECONDARY outcome
Timeframe: Two years post therapy.For OS, only deaths are considered failures for OS. Kaplan-Meier estimates of the OS curves are computed along with estimates of standard errors by Peto's method. Please note the unit of measurement of probabilities are percentages.
Outcome measures
| Measure |
Stratum 1
n=12 Participants
Minimal disseminated disease (MDD) \<1% at diagnosis in T-lymphoblastic lymphoma No bone marrow involvement microscopically at diagnosis in B-lymphoblastic lymphoma
Patients should not have:
* Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (\<5 WBC/µL of CSF with blasts) or traumatic LP (\>10 RBC/µL of CSF with blasts)
* Overt testicular involvement (evidenced by ultrasonogram).
|
Stratum 2
n=7 Participants
* MDD ≥1% and MRD negative (\<0.01%) on day 8 in T-lymphoblastic lymphoma
* Bone marrow involvement microscopically present at diagnosis in B-lymphoblastic lymphoma
* Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (\<5 WBC/µL of CSF with blasts) or traumatic LP (\>10 RBC/µL of CSF with blasts) but does not fulfill the criteria of stratum 3
* Overt testicular involvement (evidenced by ultrasonogram) but does not fulfill the criteria of stratum 3
|
Stratum 3
n=4 Participants
Any patients with MDD ≥1% and MRD positive (≥0.01%) on day 8 in T-lymphoblastic lymphoma
|
All Enrollments
n=23 Participants
Twenty-three (23) eligible patients
|
|---|---|---|---|---|
|
Probability of Overall Survival (OS)
|
91.7 percentage of patients alive
Interval 53.9 to 98.8
|
71.4 percentage of patients alive
Interval 25.8 to 92.0
|
100 percentage of patients alive
Interval 100.0 to 100.0
|
86.96 percentage of patients alive
Interval 64.81 to 95.6
|
SECONDARY outcome
Timeframe: At DiagnosisPopulation: Fourteen patients had MDD data at diagnosis.
Detectable disease in bone marrow or blood: A binary measure, positive (detectable), negative (non-detectable)
Outcome measures
| Measure |
Stratum 1
n=5 Participants
Minimal disseminated disease (MDD) \<1% at diagnosis in T-lymphoblastic lymphoma No bone marrow involvement microscopically at diagnosis in B-lymphoblastic lymphoma
Patients should not have:
* Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (\<5 WBC/µL of CSF with blasts) or traumatic LP (\>10 RBC/µL of CSF with blasts)
* Overt testicular involvement (evidenced by ultrasonogram).
|
Stratum 2
n=5 Participants
* MDD ≥1% and MRD negative (\<0.01%) on day 8 in T-lymphoblastic lymphoma
* Bone marrow involvement microscopically present at diagnosis in B-lymphoblastic lymphoma
* Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (\<5 WBC/µL of CSF with blasts) or traumatic LP (\>10 RBC/µL of CSF with blasts) but does not fulfill the criteria of stratum 3
* Overt testicular involvement (evidenced by ultrasonogram) but does not fulfill the criteria of stratum 3
|
Stratum 3
n=4 Participants
Any patients with MDD ≥1% and MRD positive (≥0.01%) on day 8 in T-lymphoblastic lymphoma
|
All Enrollments
Twenty-three (23) eligible patients
|
|---|---|---|---|---|
|
Minimal Disseminated Disease (MDD)
Negative
|
4 participants
|
2 participants
|
0 participants
|
—
|
|
Minimal Disseminated Disease (MDD)
Positive
|
1 participants
|
3 participants
|
4 participants
|
—
|
SECONDARY outcome
Timeframe: Day 8Population: Seventeen participants had MRD data at day 8
Detectable disease in bone marrow or blood: A binary measure, positive (detectable), negative (non-detectable)
Outcome measures
| Measure |
Stratum 1
n=8 Participants
Minimal disseminated disease (MDD) \<1% at diagnosis in T-lymphoblastic lymphoma No bone marrow involvement microscopically at diagnosis in B-lymphoblastic lymphoma
Patients should not have:
* Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (\<5 WBC/µL of CSF with blasts) or traumatic LP (\>10 RBC/µL of CSF with blasts)
* Overt testicular involvement (evidenced by ultrasonogram).
|
Stratum 2
n=5 Participants
* MDD ≥1% and MRD negative (\<0.01%) on day 8 in T-lymphoblastic lymphoma
* Bone marrow involvement microscopically present at diagnosis in B-lymphoblastic lymphoma
* Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (\<5 WBC/µL of CSF with blasts) or traumatic LP (\>10 RBC/µL of CSF with blasts) but does not fulfill the criteria of stratum 3
* Overt testicular involvement (evidenced by ultrasonogram) but does not fulfill the criteria of stratum 3
|
Stratum 3
n=4 Participants
Any patients with MDD ≥1% and MRD positive (≥0.01%) on day 8 in T-lymphoblastic lymphoma
|
All Enrollments
Twenty-three (23) eligible patients
|
|---|---|---|---|---|
|
Minimal Residual Disease (MRD)
Positive
|
0 participants
|
1 participants
|
4 participants
|
—
|
|
Minimal Residual Disease (MRD)
Negative
|
8 participants
|
4 participants
|
0 participants
|
—
|
Adverse Events
Stratum 1
Serious events: 0 serious events
Other events: 12 other events
Deaths: 2 deaths
Stratum 2
Serious events: 1 serious events
Other events: 7 other events
Deaths: 2 deaths
Stratum 3
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
All Enrollments
Serious events: 1 serious events
Other events: 23 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Stratum 1
n=12 participants at risk
Minimal disseminated disease (MDD) \<1% at diagnosis in T-lymphoblastic lymphoma No bone marrow involvement microscopically at diagnosis in B-lymphoblastic lymphoma
Patients should not have:
* Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (\<5 WBC/µL of CSF with blasts) or traumatic LP (\>10 RBC/µL of CSF with blasts)
* Overt testicular involvement (evidenced by ultrasonogram).
|
Stratum 2
n=7 participants at risk
* MDD ≥1% and MRD negative (\<0.01%) on day 8 in T-lymphoblastic lymphoma
* Bone marrow involvement microscopically present at diagnosis in B-lymphoblastic lymphoma
* Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (\<5 WBC/µL of CSF with blasts) or traumatic LP (\>10 RBC/µL of CSF with blasts) but does not fulfill the criteria of stratum 3
* Overt testicular involvement (evidenced by ultrasonogram) but does not fulfill the criteria of stratum 3
|
Stratum 3
n=4 participants at risk
Any patients with MDD ≥1% and MRD positive (≥0.01%) on day 8 in T-lymphoblastic lymphoma
|
All Enrollments
n=23 participants at risk
Twenty-three (23) eligible patients
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
14.3%
1/7 • Number of events 1 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • Number of events 1 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
Other adverse events
| Measure |
Stratum 1
n=12 participants at risk
Minimal disseminated disease (MDD) \<1% at diagnosis in T-lymphoblastic lymphoma No bone marrow involvement microscopically at diagnosis in B-lymphoblastic lymphoma
Patients should not have:
* Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (\<5 WBC/µL of CSF with blasts) or traumatic LP (\>10 RBC/µL of CSF with blasts)
* Overt testicular involvement (evidenced by ultrasonogram).
|
Stratum 2
n=7 participants at risk
* MDD ≥1% and MRD negative (\<0.01%) on day 8 in T-lymphoblastic lymphoma
* Bone marrow involvement microscopically present at diagnosis in B-lymphoblastic lymphoma
* Any CNS involvement: CNS-3 status (i.e., ≥5 WBC/µL of CSF with blasts or cranial nerve palsy), CNS-2 status (\<5 WBC/µL of CSF with blasts) or traumatic LP (\>10 RBC/µL of CSF with blasts) but does not fulfill the criteria of stratum 3
* Overt testicular involvement (evidenced by ultrasonogram) but does not fulfill the criteria of stratum 3
|
Stratum 3
n=4 participants at risk
Any patients with MDD ≥1% and MRD positive (≥0.01%) on day 8 in T-lymphoblastic lymphoma
|
All Enrollments
n=23 participants at risk
Twenty-three (23) eligible patients
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
91.7%
11/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
57.1%
4/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
100.0%
4/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
82.6%
19/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Infections and infestations
Upper respiratory infection
|
83.3%
10/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
42.9%
3/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
75.0%
3/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
69.6%
16/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Infections and infestations
Mucosal Infection
|
41.7%
5/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
28.6%
2/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
34.8%
8/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Musculoskeletal and connective tissue disorders
Avascular necrosis
|
66.7%
8/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
57.1%
4/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
75.0%
3/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
65.2%
15/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Infections and infestations
Skin infection
|
50.0%
6/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
42.9%
3/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
43.5%
10/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
4/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
28.6%
2/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
30.4%
7/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
General disorders
Fever
|
41.7%
5/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
42.9%
3/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
39.1%
9/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Investigations
Blood bilirubin increased
|
33.3%
4/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
14.3%
1/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
26.1%
6/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
25.0%
3/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
42.9%
3/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
50.0%
2/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
34.8%
8/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Infections and infestations
Sinusitis
|
41.7%
5/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
28.6%
2/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
34.8%
8/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
41.7%
5/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
50.0%
2/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
30.4%
7/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Infections and infestations
Otitis media
|
33.3%
4/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
28.6%
2/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
30.4%
7/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Investigations
Lipase increased
|
8.3%
1/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
8.7%
2/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
4/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
14.3%
1/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
21.7%
5/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
25.0%
3/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
28.6%
2/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
26.1%
6/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Psychiatric disorders
Depression
|
16.7%
2/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
28.6%
2/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
75.0%
3/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
30.4%
7/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Infections and infestations
Urinary tract infection
|
25.0%
3/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
14.3%
1/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
21.7%
5/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Investigations
Cholesterol high
|
16.7%
2/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
14.3%
1/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
17.4%
4/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
3/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
42.9%
3/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
26.1%
6/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Nervous system disorders
Neuralgia
|
25.0%
3/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
57.1%
4/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
34.8%
8/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Vascular disorders
Hypotension
|
25.0%
3/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
17.4%
4/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
14.3%
1/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
13.0%
3/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Infections and infestations
Enterocolitis infectious
|
8.3%
1/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
28.6%
2/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
50.0%
2/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
21.7%
5/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Infections and infestations
Lung infection
|
25.0%
3/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
14.3%
1/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
21.7%
5/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
3/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
13.0%
3/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
2/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
28.6%
2/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
50.0%
2/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
26.1%
6/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Gastrointestinal disorders
Colitis
|
16.7%
2/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
28.6%
2/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
50.0%
2/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
26.1%
6/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.0%
3/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
14.3%
1/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
21.7%
5/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Investigations
Serum amylase increased
|
8.3%
1/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
2/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
13.0%
3/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
75.0%
3/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
13.0%
3/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
2/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
14.3%
1/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
17.4%
4/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Gastrointestinal disorders
Pancreatitis
|
16.7%
2/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
13.0%
3/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
8.3%
1/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
28.6%
2/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
13.0%
3/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Infections and infestations
Paronychia
|
16.7%
2/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
8.7%
2/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Infections and infestations
Vaginal infection
|
8.3%
1/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Metabolism and nutrition disorders
Anorexia
|
8.3%
1/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
28.6%
2/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
17.4%
4/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
14.3%
1/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
8.7%
2/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
General disorders
Pain
|
16.7%
2/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
13.0%
3/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
16.7%
2/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
13.0%
3/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Infections and infestations
Wound infection
|
0.00%
0/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
28.6%
2/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
8.7%
2/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
16.7%
2/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
14.3%
1/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
13.0%
3/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
16.7%
2/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
13.0%
3/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Nervous system disorders
Syncope
|
16.7%
2/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
14.3%
1/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
13.0%
3/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Vascular disorders
Thromboembolic event
|
8.3%
1/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
14.3%
1/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
8.7%
2/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
28.6%
2/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
8.7%
2/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Gastrointestinal disorders
Rectal pain
|
8.3%
1/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
14.3%
1/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
8.7%
2/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Immune system disorders
Allergic reaction
|
8.3%
1/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
14.3%
1/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
8.7%
2/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Immune system disorders
Allergic reaction to Asparaginase
|
8.3%
1/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
8.7%
2/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Infections and infestations
Lip infection
|
8.3%
1/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
8.7%
2/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Infections and infestations
Pharyngitis
|
16.7%
2/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
8.7%
2/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
14.3%
1/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
8.7%
2/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
14.3%
1/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
8.7%
2/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
0.00%
0/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
28.6%
2/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
8.7%
2/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Investigations
GGT increased
|
16.7%
2/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
8.7%
2/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
14.3%
1/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
8.7%
2/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
2/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
8.7%
2/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Nervous system disorders
Cognitive disturbance
|
8.3%
1/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
8.7%
2/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Nervous system disorders
Seizure
|
8.3%
1/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
14.3%
1/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
8.7%
2/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
8.3%
1/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
16.7%
2/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
8.7%
2/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Vascular disorders
Hypertension
|
0.00%
0/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
14.3%
1/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
8.7%
2/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Blood and lymphatic system disorders
Anemia
|
8.3%
1/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Cardiac disorders
Pericardial effusion
|
8.3%
1/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
8.3%
1/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Gastrointestinal disorders
Anal pain
|
0.00%
0/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Gastrointestinal disorders
Enterocolitis
|
8.3%
1/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Gastrointestinal disorders
Gastritis
|
8.3%
1/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
14.3%
1/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Gastrointestinal disorders
Pancreatic necrosis
|
0.00%
0/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
General disorders
Edema limbs
|
0.00%
0/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
General disorders
Malaise
|
8.3%
1/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Hepatobiliary disorders
Cholecystitis
|
8.3%
1/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Immune system disorders
Anaphylaxis
|
0.00%
0/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
14.3%
1/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Infections and infestations
Sepsis
|
0.00%
0/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
14.3%
1/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Infections and infestations
Small intestine infection
|
8.3%
1/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Infections and infestations
Soft tissue infection
|
8.3%
1/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
14.3%
1/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
14.3%
1/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Investigations
Weight loss
|
8.3%
1/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.00%
0/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
8.3%
1/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
8.3%
1/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
14.3%
1/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
8.3%
1/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
8.3%
1/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
14.3%
1/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Nervous system disorders
Akathisia
|
0.00%
0/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Nervous system disorders
Headache
|
0.00%
0/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Nervous system disorders
Presyncope
|
8.3%
1/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Nervous system disorders
Radiculitis
|
0.00%
0/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Psychiatric disorders
Anxiety
|
8.3%
1/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Renal and urinary disorders
Acute kidney injury
|
8.3%
1/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.3%
1/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
14.3%
1/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
25.0%
1/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
8.3%
1/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
|
Vascular disorders
Vascular disorders - Other, specify
|
8.3%
1/12 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/7 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
0.00%
0/4 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
4.3%
1/23 • From the start of treatment to 30 days after the last treatment is taken. Treatment last for 2 to 2½ years.
|
Additional Information
Hiroto Inaba, MD, PhD
St. Jude Children's Research Hospital
Phone: (901) 595-3144
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place