Trial Outcomes & Findings for N2001-02: I-MIBG With Intensive Chemotherapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma (NCT NCT00253435)
NCT ID: NCT00253435
Last Updated: 2023-04-10
Results Overview
Tumor response based on evaluation performed on day 60 or at the time of disease progression/recurrence or start of another treatment - whichever comes first. Such evaluations will include 123I-MIBG scan, CT/MRI, urine catecholamine measurement, and bone marrow analysis (for those with marrow disease at study entry).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Response assessed 60 days post stem cell infusion
Results posted on
2023-04-10
Participant Flow
Opened to accrual on 12/10/04 \& closed to accrual on 07/21/10; suspended 6 times for amendments. Opened at 12 NANT institutions. 1st patient started on treatment on 03/11/05. 50 patients enrolled; all eligible \& evaluable for toxicity. 49 patients were evaluable for response.
Participant milestones
| Measure |
Poor Risk Patients
Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
|
Good Risk Patients
Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
8
|
|
Overall Study
1st Interim Analysis
|
15
|
8
|
|
Overall Study
2nd Interim Analysis
|
10
|
0
|
|
Overall Study
3rd Interim Analysis
|
10
|
0
|
|
Overall Study
COMPLETED
|
42
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
N2001-02: I-MIBG With Intensive Chemotherapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma
Baseline characteristics by cohort
| Measure |
Poor Risk Patients
n=42 Participants
Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
|
Good Risk Patients
n=8 Participants
Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.0 years
n=5 Participants
|
7.7 years
n=7 Participants
|
6.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
GFR Status
Normal GFR
|
30 participants
n=5 Participants
|
7 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
GFR Status
Low GFR
|
12 participants
n=5 Participants
|
1 participants
n=7 Participants
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Response assessed 60 days post stem cell infusionPopulation: One patient in the Poor Risk Cohort underwent surgery for resection (of his only measureable lesion) prior to post-treatment assessment and is not evaluable for response.
Tumor response based on evaluation performed on day 60 or at the time of disease progression/recurrence or start of another treatment - whichever comes first. Such evaluations will include 123I-MIBG scan, CT/MRI, urine catecholamine measurement, and bone marrow analysis (for those with marrow disease at study entry).
Outcome measures
| Measure |
Poor Risk Patients
n=41 Participants
Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
|
Good Risk Patients
n=8 Participants
Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
|
|---|---|---|
|
Response (Complete Response, Very Good Partial Response, and Partial Response) at 60-days Post Stem Cell Infusion
|
4 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 3 years since start of treatmentPopulation: Estimated probability of 3-year progression free survival for all patients enrolled in each risk group.
EFS will be measured from start of treatment until progression, death or start of another treatment - whichever comes first. We report the estimated probability of EFS at 3 years.
Outcome measures
| Measure |
Poor Risk Patients
n=42 Participants
Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
|
Good Risk Patients
n=8 Participants
Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
|
|---|---|---|
|
Event-free Survival (EFS) at 3 Years
|
0.20 Estimated probability
|
0.38 Estimated probability
|
SECONDARY outcome
Timeframe: From treatment start until 60 days post stem cell infusionPopulation: All patients who began treatment
• Engraftment toxicity: delayed engraftment and/or failure to engraft defined as: * neutrophils (ANC) \< 500/μL by day 28 post transplant, or * platelets \< 20,000 /μL by day 56 post transplant, or * if additional stem cells are required to be infused for any medical reason prior to initial engraftment of neutrophils or platelets.
Outcome measures
| Measure |
Poor Risk Patients
n=42 Participants
Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
|
Good Risk Patients
n=8 Participants
Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
|
|---|---|---|
|
Engraftment DLT
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Between start of MIBG treatment and 60 days post stem cell infusionPopulation: All patients who began treatment
Dose limiting veno-occlusive disease (VOD) defined as: * the presence of hepatomegaly with right upper quadrant tenderness and an elevation of total bilirubin \> grade 1, PLUS * the presence of grade 3 abnormalities of any ONE of the following: total bilirubin, hypoalbuminemia, weight gain, or hypoxia without other attribution
Outcome measures
| Measure |
Poor Risk Patients
n=42 Participants
Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
|
Good Risk Patients
n=8 Participants
Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
|
|---|---|---|
|
Dose Limiting Veno-occlusive Disease (VOD) / Sinusoidal Obstruction Syndrome SOS
|
6 participants
|
0 participants
|
Adverse Events
Poor Risk Patients
Serious events: 12 serious events
Other events: 42 other events
Deaths: 0 deaths
Good Risk Patients
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Poor Risk Patients
n=42 participants at risk
Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
|
Good Risk Patients
n=8 participants at risk
Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other (DELAYED PLATELET ENGRAFTMENT)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other (INFUSION OF BACKUP STEM CELLS)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
4.8%
2/42 • Number of events 2
|
0.00%
0/8
|
|
Hepatobiliary disorders
Hepatobiliary/Pancreas - Other (HEPATOMEGALY)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils (Blood)
|
4.8%
2/42 • Number of events 3
|
0.00%
0/8
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils (Catheter-related)
|
2.4%
1/42 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
11.9%
5/42 • Number of events 5
|
0.00%
0/8
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
0.00%
0/42
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Platelets
|
2.4%
1/42 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Weight gain
|
11.9%
5/42 • Number of events 5
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
4.8%
2/42 • Number of events 2
|
0.00%
0/8
|
|
Nervous system disorders
Pain (Head/headache)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/42
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
9.5%
4/42 • Number of events 4
|
12.5%
1/8 • Number of events 1
|
|
Vascular disorders
Hypotension
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
Other adverse events
| Measure |
Poor Risk Patients
n=42 participants at risk
Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
|
Good Risk Patients
n=8 participants at risk
Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other (DELAYED ENGRAFTMENT ANC)
|
0.00%
0/42
|
12.5%
1/8 • Number of events 1
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other (INFUSION OF BACKUP SC FOR DELAYED ENGRAFTMENT)
|
0.00%
0/42
|
12.5%
1/8 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia (fever of unknown origin)
|
73.8%
31/42 • Number of events 31
|
75.0%
6/8 • Number of events 6
|
|
Blood and lymphatic system disorders
Hemoglobin
|
95.2%
40/42 • Number of events 40
|
87.5%
7/8 • Number of events 7
|
|
Blood and lymphatic system disorders
Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Blood and lymphatic system disorders
Lymphatics - Other (CAPILLARY LEAK)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Blood and lymphatic system disorders
Lymphatics - Other (GENERALIZED EDEMA)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Cardiac disorders
Cardiac Arrhythmia - Other (MURMUR)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Cardiac disorders
Cardiac Arrhythmia - Other (SINUS TACHYCARDIA)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Cardiac disorders
Cardiac General - Other (SYSTOLIC MURMUR)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia (Atrial tachycardia/Paroxysmal Atrial Tachycardia)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia (Sinus tachycardia)
|
26.2%
11/42 • Number of events 11
|
0.00%
0/8
|
|
Cardiac disorders
Ventricular arrhythmia (Ventricular arrhythmia NOS)
|
0.00%
0/42
|
12.5%
1/8 • Number of events 1
|
|
Ear and labyrinth disorders
Hearing: patients with/without baseline audiogram and enrolled in a monitoring program
|
2.4%
1/42 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
Ear and labyrinth disorders
Hearing: patients without baseline audiogram and not enrolled in a monitoring program
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Ear and labyrinth disorders
Otitis, middle ear (non-infectious)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Ear and labyrinth disorders
Pain (Middle ear)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Endocrine disorders
Endocrine - Other (TSH)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Endocrine disorders
Thyroid function, high (hyperthyroidism, thyrotoxicosis)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Eye disorders
Ocular/Visual - Other (BILATERAL CONJUNCTIVAL HEMORRHAGE)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Eye disorders
Pain (Eye)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
11.9%
5/42 • Number of events 5
|
0.00%
0/8
|
|
Gastrointestinal disorders
Cheilitis
|
9.5%
4/42 • Number of events 4
|
0.00%
0/8
|
|
Gastrointestinal disorders
Constipation
|
19.0%
8/42 • Number of events 8
|
25.0%
2/8 • Number of events 2
|
|
Gastrointestinal disorders
Dental: teeth
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Gastrointestinal disorders
Diarrhea
|
76.2%
32/42 • Number of events 32
|
50.0%
4/8 • Number of events 4
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
11.9%
5/42 • Number of events 5
|
0.00%
0/8
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
4.8%
2/42 • Number of events 2
|
0.00%
0/8
|
|
Gastrointestinal disorders
Gastrointestinal - Other (HICCUPS)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Gastrointestinal disorders
Gastrointestinal - Other (LOOSE TEETH)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Gastrointestinal disorders
Gastrointestinal - Other (REFLUX)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
7.1%
3/42 • Number of events 3
|
0.00%
0/8
|
|
Gastrointestinal disorders
Hemorrhage, GI (Lower GI NOS)
|
4.8%
2/42 • Number of events 2
|
0.00%
0/8
|
|
Gastrointestinal disorders
Hemorrhage, GI (Oral cavity)
|
4.8%
2/42 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhage, GI (Stomach)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Gastrointestinal disorders
Hemorrhage, GI (Upper GI NOS)
|
11.9%
5/42 • Number of events 5
|
0.00%
0/8
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) (Anus)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) (Esophagus)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) (Oral cavity)
|
69.0%
29/42 • Number of events 29
|
62.5%
5/8 • Number of events 5
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) (Rectum)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic) (Large bowel)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic) (Oral cavity)
|
33.3%
14/42 • Number of events 14
|
50.0%
4/8 • Number of events 4
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic) (Small bowel)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic) (Stomach)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Gastrointestinal disorders
Nausea
|
76.2%
32/42 • Number of events 32
|
62.5%
5/8 • Number of events 5
|
|
Gastrointestinal disorders
Obstruction, GI (Small bowel NOS)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Gastrointestinal disorders
Pain (Abdomen NOS)
|
47.6%
20/42 • Number of events 20
|
37.5%
3/8 • Number of events 3
|
|
Gastrointestinal disorders
Pain (Esophagus)
|
2.4%
1/42 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Pain (Oral cavity)
|
45.2%
19/42 • Number of events 19
|
37.5%
3/8 • Number of events 3
|
|
Gastrointestinal disorders
Pain (Oral-gums)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Gastrointestinal disorders
Pain (Rectum)
|
2.4%
1/42 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Pain (Stomach)
|
4.8%
2/42 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Salivary gland changes/saliva
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Gastrointestinal disorders
Typhlitis (cecal inflammation)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Gastrointestinal disorders
Vomiting
|
78.6%
33/42 • Number of events 33
|
87.5%
7/8 • Number of events 7
|
|
General disorders
Constitutional Symptoms - Other (BRITTLE HAIR)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
General disorders
Constitutional Symptoms - Other (RHINORRHEA)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
General disorders
Edema:head and neck
|
11.9%
5/42 • Number of events 5
|
25.0%
2/8 • Number of events 2
|
|
General disorders
Edema:limb
|
7.1%
3/42 • Number of events 3
|
0.00%
0/8
|
|
General disorders
Edema:trunk/genital
|
4.8%
2/42 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
28.6%
12/42 • Number of events 12
|
0.00%
0/8
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
38.1%
16/42 • Number of events 16
|
25.0%
2/8 • Number of events 2
|
|
General disorders
Irritability (children <3 years of age)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
General disorders
Pain (Chest/thorax NOS)
|
4.8%
2/42 • Number of events 2
|
0.00%
0/8
|
|
General disorders
Pain (Face)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
General disorders
Pain (Pain NOS)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
General disorders
Pain - Other (BROVIAC SITE)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
General disorders
Pain - Other (CVC SITE)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
General disorders
Pain - Other (GENERAL (NOS))
|
4.8%
2/42 • Number of events 2
|
0.00%
0/8
|
|
General disorders
Pain - Other (MOUTH PAIN)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
General disorders
Pain - Other (MUCOSITIS)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
General disorders
Pain - Other (OROPHANRIX)
|
0.00%
0/42
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Pain - Other (PAROTID GLAND)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
General disorders
Pain - Other (WHOLE BODY)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
General disorders
Rigors/chills
|
4.8%
2/42 • Number of events 2
|
0.00%
0/8
|
|
Hepatobiliary disorders
Hepatobiliary/Pancreas - Other (CHOLANGITIS)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Hepatobiliary disorders
Liver dysfunction/failure (clinical)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Hepatobiliary disorders
Pain (Liver)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Hepatobiliary disorders
Portal vein flow
|
7.1%
3/42 • Number of events 3
|
0.00%
0/8
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
4.8%
2/42 • Number of events 2
|
0.00%
0/8
|
|
Immune system disorders
Cytokine release syndrome/acute infusion reaction
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) (Blood)
|
11.9%
5/42 • Number of events 5
|
25.0%
2/8 • Number of events 2
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) (Catheter-related)
|
4.8%
2/42 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) (Lung (pneumonia))
|
4.8%
2/42 • Number of events 2
|
0.00%
0/8
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) (Mucosa)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) (Sinus)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) (Skin (cellulitis))
|
2.4%
1/42 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
Infections and infestations
Infection - Other (ASPERGILLUS OF MOUTH)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Infections and infestations
Infection - Other (L-PRESEPTAL CELLULITIS)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Infections and infestations
Infection - Other (ORAL CANDIDA)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Infections and infestations
Infection - Other (PERIRECTAL CELLULITIS)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Infections and infestations
Infection - Other (URINE + FOR CYTOMEGALOVIRUS)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Infections and infestations
Infection - Other (VARICELLA)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils (Blood)
|
14.3%
6/42 • Number of events 6
|
12.5%
1/8 • Number of events 1
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils (Bronchus)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils (Catheter-related)
|
7.1%
3/42 • Number of events 3
|
0.00%
0/8
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils (Colon)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils (Lung (pneumonia))
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils (Oral cavity-gums (gingivitis))
|
4.8%
2/42 • Number of events 2
|
0.00%
0/8
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils (Sinus)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils (Small bowel NOS)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils (Upper airway NOS)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Infections and infestations
Infection with unknown ANC (Catheter-related)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Infections and infestations
Infection with unknown ANC (Skin (cellulitis))
|
0.00%
0/42
|
12.5%
1/8 • Number of events 1
|
|
Infections and infestations
Opportunistic infection associated with >=Grade 2 Lymphopenia
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Injury, poisoning and procedural complications
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
4.8%
2/42 • Number of events 2
|
0.00%
0/8
|
|
Injury, poisoning and procedural complications
Rash: dermatitis associated with radiation (Chemoradiation)
|
4.8%
2/42 • Number of events 2
|
0.00%
0/8
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
81.0%
34/42 • Number of events 34
|
100.0%
8/8 • Number of events 8
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
85.7%
36/42 • Number of events 36
|
100.0%
8/8 • Number of events 8
|
|
Investigations
Alkaline phosphatase
|
19.0%
8/42 • Number of events 8
|
25.0%
2/8 • Number of events 2
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
23.8%
10/42 • Number of events 10
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Cholesterol, serum-high (hypercholesteremia)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Investigations
Creatinine
|
16.7%
7/42 • Number of events 7
|
0.00%
0/8
|
|
Investigations
Fibrinogen
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Investigations
GGT (gamma-Glutamyl transpeptidase)
|
35.7%
15/42 • Number of events 15
|
0.00%
0/8
|
|
Investigations
INR (International Normalized Ratio of prothrombin time)
|
16.7%
7/42 • Number of events 7
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Leukocytes (total WBC)
|
90.5%
38/42 • Number of events 38
|
100.0%
8/8 • Number of events 8
|
|
Investigations
Lymphopenia
|
71.4%
30/42 • Number of events 30
|
62.5%
5/8 • Number of events 5
|
|
Investigations
Metabolic/Laboratory - Other (CHLORIDE)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Investigations
Metabolic/Laboratory - Other (DECREASED TOTAL PROTEIN)
|
0.00%
0/42
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Metabolic/Laboratory - Other (HYPERCHLOREMIA)
|
0.00%
0/42
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Metabolic/Laboratory - Other (HYPERCHLORIDEMIA)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Investigations
Metabolic/Laboratory - Other (HYPERPHOSPHATEMIA)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Investigations
Metabolic/Laboratory - Other (INCREASED CHLORIDE)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Investigations
Metabolic/Laboratory - Other (INCREASED FIBRINOGEN)
|
0.00%
0/42
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Metabolic/Laboratory - Other (PRE-ALBUMIN)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
92.9%
39/42 • Number of events 39
|
87.5%
7/8 • Number of events 7
|
|
Investigations
PTT (Partial Thromboplastin Time)
|
19.0%
8/42 • Number of events 8
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Platelets
|
95.2%
40/42 • Number of events 40
|
87.5%
7/8 • Number of events 7
|
|
Investigations
Weight gain
|
23.8%
10/42 • Number of events 10
|
0.00%
0/8
|
|
Investigations
Weight loss
|
19.0%
8/42 • Number of events 8
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Acidosis (metabolic or respiratory)
|
4.8%
2/42 • Number of events 2
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
90.5%
38/42 • Number of events 38
|
100.0%
8/8 • Number of events 8
|
|
Metabolism and nutrition disorders
Alkalosis (metabolic or respiratory)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Anorexia
|
59.5%
25/42 • Number of events 25
|
75.0%
6/8 • Number of events 6
|
|
Metabolism and nutrition disorders
Bicarbonate, serum-low
|
19.0%
8/42 • Number of events 8
|
12.5%
1/8 • Number of events 1
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
19.0%
8/42 • Number of events 8
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
69.0%
29/42 • Number of events 29
|
75.0%
6/8 • Number of events 6
|
|
Metabolism and nutrition disorders
Dehydration
|
9.5%
4/42 • Number of events 4
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
71.4%
30/42 • Number of events 30
|
100.0%
8/8 • Number of events 8
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
38.1%
16/42 • Number of events 16
|
12.5%
1/8 • Number of events 1
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
28.6%
12/42 • Number of events 12
|
12.5%
1/8 • Number of events 1
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
52.4%
22/42 • Number of events 22
|
75.0%
6/8 • Number of events 6
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
61.9%
26/42 • Number of events 26
|
62.5%
5/8 • Number of events 5
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
28.6%
12/42 • Number of events 12
|
25.0%
2/8 • Number of events 2
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
76.2%
32/42 • Number of events 32
|
87.5%
7/8 • Number of events 7
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
21.4%
9/42 • Number of events 9
|
37.5%
3/8 • Number of events 3
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
81.0%
34/42 • Number of events 34
|
100.0%
8/8 • Number of events 8
|
|
Metabolism and nutrition disorders
Triglyceride, serum-high (hypertriglyceridemia)
|
66.7%
28/42 • Number of events 28
|
75.0%
6/8 • Number of events 6
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) (Extremity-lower)
|
2.4%
1/42 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) (Extremity-upper)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (NOT SPECIFIED)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (OCCASIONAL ACHES AND PAINS)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Pain (Back)
|
7.1%
3/42 • Number of events 3
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Pain (Bone)
|
4.8%
2/42 • Number of events 2
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Pain (Chest wall)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Pain (Extremity-limb)
|
21.4%
9/42 • Number of events 9
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Pain (Joint)
|
7.1%
3/42 • Number of events 3
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Pain (Neck)
|
7.1%
3/42 • Number of events 3
|
0.00%
0/8
|
|
Nervous system disorders
Neurology - Other (ACHY FEELING)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Nervous system disorders
Neurology - Other (DYSTONIC REACTION)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Nervous system disorders
Neurology - Other (GENERALIZED TENDERNESS)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Nervous system disorders
Neuropathy: cranial (CN VII Motor-face; Sensory-taste)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Nervous system disorders
Neuropathy: motor
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Nervous system disorders
Neuropathy: sensory
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Nervous system disorders
Pain (Head/headache)
|
11.9%
5/42 • Number of events 5
|
0.00%
0/8
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Nervous system disorders
Syncope (fainting)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
9.5%
4/42 • Number of events 4
|
0.00%
0/8
|
|
Nervous system disorders
Tremor
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Psychiatric disorders
Confusion
|
4.8%
2/42 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
7.1%
3/42 • Number of events 3
|
0.00%
0/8
|
|
Psychiatric disorders
Mood alteration (Agitation)
|
4.8%
2/42 • Number of events 2
|
0.00%
0/8
|
|
Psychiatric disorders
Mood alteration (Anxiety)
|
9.5%
4/42 • Number of events 4
|
12.5%
1/8 • Number of events 1
|
|
Psychiatric disorders
Mood alteration (Depression)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Psychiatric disorders
Psychosis (hallucinations/delusions)
|
4.8%
2/42 • Number of events 2
|
25.0%
2/8 • Number of events 2
|
|
Renal and urinary disorders
Bladder spasms
|
4.8%
2/42 • Number of events 2
|
0.00%
0/8
|
|
Renal and urinary disorders
Cystitis
|
4.8%
2/42 • Number of events 2
|
0.00%
0/8
|
|
Renal and urinary disorders
Hemoglobinuria
|
2.4%
1/42 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
Renal and urinary disorders
Hemorrhage, GU (Bladder)
|
4.8%
2/42 • Number of events 2
|
0.00%
0/8
|
|
Renal and urinary disorders
Hemorrhage, GU (Urinary NOS)
|
4.8%
2/42 • Number of events 2
|
0.00%
0/8
|
|
Renal and urinary disorders
Pain (Bladder)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Renal and urinary disorders
Proteinuria
|
28.6%
12/42 • Number of events 12
|
0.00%
0/8
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (DECREASED URINE OUTPUT)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (FLUID RETENTION)
|
4.8%
2/42 • Number of events 2
|
0.00%
0/8
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
7.1%
3/42 • Number of events 3
|
0.00%
0/8
|
|
Reproductive system and breast disorders
Pain (Pelvis)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Reproductive system and breast disorders
Pain (Penis)
|
2.4%
1/42 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
Reproductive system and breast disorders
Pain (Scrotum)
|
4.8%
2/42 • Number of events 2
|
0.00%
0/8
|
|
Reproductive system and breast disorders
Vaginal mucositis
|
0.00%
0/42
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
7.1%
3/42 • Number of events 3
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
4.8%
2/42 • Number of events 2
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
31.0%
13/42 • Number of events 13
|
25.0%
2/8 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
7.1%
3/42 • Number of events 3
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory (Nose)
|
42.9%
18/42 • Number of events 18
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory (Respiratory tract NOS)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
23.8%
10/42 • Number of events 10
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Mucositis/stomatitis (clinical exam) (Larynx)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Mucositis/stomatitis (clinical exam) (Pharynx)
|
7.1%
3/42 • Number of events 3
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Mucositis/stomatitis (functional/symptomatic) (Pharynx)
|
2.4%
1/42 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reactions
|
0.00%
0/42
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pain (Larynx)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Pain (Throat/pharynx/larynx)
|
19.0%
8/42 • Number of events 8
|
50.0%
4/8 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
7.1%
3/42 • Number of events 3
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
4.8%
2/42 • Number of events 2
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (CONGESTION)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (HYPERCARBIA)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (RHINORRHEA)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (RUNNY NOSE)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (TACHYPNEIC)
|
4.8%
2/42 • Number of events 2
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (DRY LIPS)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (FACIAL ABRAISIONS)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (INGROWN TOENAIL)
|
0.00%
0/42
|
12.5%
1/8 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (LACERATION)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (PEELING SKIN)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (PERIORBITAL ECCHYMOSES)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (PSEUDOMEMBRANOUS CHANGES)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (SORE/SCAB)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (SUN BURN)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (ZOSTER LESION)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.5%
4/42 • Number of events 4
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
11.9%
5/42 • Number of events 5
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
11.9%
5/42 • Number of events 5
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
|
7.1%
3/42 • Number of events 3
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
19.0%
8/42 • Number of events 8
|
37.5%
3/8 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
45.2%
19/42 • Number of events 19
|
12.5%
1/8 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Vascular disorders
Flushing
|
7.1%
3/42 • Number of events 3
|
0.00%
0/8
|
|
Vascular disorders
Hematoma
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Vascular disorders
Hemorrhage/Bleeding - Other (EPISTAXIS)
|
4.8%
2/42 • Number of events 2
|
0.00%
0/8
|
|
Vascular disorders
Hemorrhage/Bleeding - Other (EYE)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Vascular disorders
Hemorrhage/Bleeding - Other (HEMATURIA)
|
2.4%
1/42 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
Vascular disorders
Hemorrhage/Bleeding - Other (HEMOPTYSIS)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Vascular disorders
Hemorrhage/Bleeding - Other (NOSE BLEED)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Vascular disorders
Hemorrhage/Bleeding - Other (TONGUE BLEED)
|
2.4%
1/42 • Number of events 1
|
0.00%
0/8
|
|
Vascular disorders
Hypertension
|
19.0%
8/42 • Number of events 8
|
0.00%
0/8
|
|
Vascular disorders
Hypotension
|
31.0%
13/42 • Number of events 13
|
12.5%
1/8 • Number of events 1
|
Additional Information
Araz Marachelian, MD, NANT Medical Director
Chidlren's Hospital Los Angeles
Phone: 323-3691-5687
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER