Trial Outcomes & Findings for Phase II Study of Cediranib (AZD2171) in Patients With Alveolar Soft Part Sarcoma (NCT NCT00942877)
NCT ID: NCT00942877
Last Updated: 2025-03-03
Results Overview
Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.0. A minimal response is defined as a 5% overall response rate (Partial Response (PR) + Complete Response (CR)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
Date treatment initiated to date off study, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
Results posted on
2025-03-03
Participant Flow
Participant milestones
| Measure |
Adult Participants w/Alveolar Soft Part Sarcoma
Adult participants will be treated with 30 mg by mouth once a day for 28 days (28-day cycles).
AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS).
|
Pediatric Participants w/Alveolar Soft Part Sarcoma
Pediatric participants (\<16 years old) will be treated with 12 mg/m\^2/day once a day for 28 days (28-day cycles).
AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS).
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
7
|
|
Overall Study
COMPLETED
|
1
|
3
|
|
Overall Study
NOT COMPLETED
|
45
|
4
|
Reasons for withdrawal
| Measure |
Adult Participants w/Alveolar Soft Part Sarcoma
Adult participants will be treated with 30 mg by mouth once a day for 28 days (28-day cycles).
AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS).
|
Pediatric Participants w/Alveolar Soft Part Sarcoma
Pediatric participants (\<16 years old) will be treated with 12 mg/m\^2/day once a day for 28 days (28-day cycles).
AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS).
|
|---|---|---|
|
Overall Study
Refused further treatment
|
1
|
1
|
|
Overall Study
Patient was not treated
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Progressive disease
|
42
|
3
|
Baseline Characteristics
ECOG applies to the adult participants only.
Baseline characteristics by cohort
| Measure |
Adult Participants w/Alveolar Soft Part Sarcoma
n=46 Participants
Adult participants will be treated with 30 mg by mouth once a day for 28 days (28-day cycles).
AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS).
|
Pediatric Participants w/Alveolar Soft Part Sarcoma
n=7 Participants
Pediatric participants will be treated with 12 mg/m\^2/day once a day for 28 days (28-day cycles).
AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS).
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=46 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=53 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=46 Participants
|
0 Participants
n=7 Participants
|
46 Participants
n=53 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=46 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=53 Participants
|
|
Age, Continuous
|
30 years
n=46 Participants
|
13 years
n=7 Participants
|
21.5 years
n=53 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=46 Participants
|
4 Participants
n=7 Participants
|
27 Participants
n=53 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=46 Participants
|
3 Participants
n=7 Participants
|
26 Participants
n=53 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=46 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=53 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=46 Participants
|
7 Participants
n=7 Participants
|
45 Participants
n=53 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=46 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=53 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=46 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=53 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=46 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=53 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=46 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=53 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=46 Participants
|
3 Participants
n=7 Participants
|
14 Participants
n=53 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=46 Participants
|
3 Participants
n=7 Participants
|
28 Participants
n=53 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=46 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=53 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=46 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=53 Participants
|
|
Region of Enrollment
United States
|
46 Participants
n=46 Participants
|
7 Participants
n=7 Participants
|
53 Participants
n=53 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Status
0
|
4 Participants
n=46 Participants • ECOG applies to the adult participants only.
|
—
|
4 Participants
n=46 Participants • ECOG applies to the adult participants only.
|
|
Eastern Cooperative Oncology Group (ECOG) Status
1
|
38 Participants
n=46 Participants • ECOG applies to the adult participants only.
|
—
|
38 Participants
n=46 Participants • ECOG applies to the adult participants only.
|
|
Eastern Cooperative Oncology Group (ECOG) Status
2
|
4 Participants
n=46 Participants • ECOG applies to the adult participants only.
|
—
|
4 Participants
n=46 Participants • ECOG applies to the adult participants only.
|
|
Lansky/Karnofsky Performance Status
100%
|
—
|
1 Participants
n=7 Participants • Lansky/Karnofsky applies to the pediatric participants only.
|
1 Participants
n=7 Participants • Lansky/Karnofsky applies to the pediatric participants only.
|
|
Lansky/Karnofsky Performance Status
90%
|
—
|
4 Participants
n=7 Participants • Lansky/Karnofsky applies to the pediatric participants only.
|
4 Participants
n=7 Participants • Lansky/Karnofsky applies to the pediatric participants only.
|
|
Lansky/Karnofsky Performance Status
80%
|
—
|
2 Participants
n=7 Participants • Lansky/Karnofsky applies to the pediatric participants only.
|
2 Participants
n=7 Participants • Lansky/Karnofsky applies to the pediatric participants only.
|
|
Prior Resection
|
35 Participants
n=46 Participants
|
3 Participants
n=7 Participants
|
38 Participants
n=53 Participants
|
|
Prior Radiation
|
27 Participants
n=46 Participants
|
2 Participants
n=7 Participants
|
29 Participants
n=53 Participants
|
|
Prior Systemic Therapy
|
—
|
4 Participants
n=7 Participants • Applies to the pediatric participants only.
|
4 Participants
n=7 Participants • Applies to the pediatric participants only.
|
|
Prior Systemic Therapies
0
|
18 Participants
n=46 Participants
|
4 Participants
n=7 Participants
|
22 Participants
n=53 Participants
|
|
Prior Systemic Therapies
1
|
18 Participants
n=46 Participants
|
1 Participants
n=7 Participants
|
19 Participants
n=53 Participants
|
|
Prior Systemic Therapies
2
|
5 Participants
n=46 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=53 Participants
|
|
Prior Systemic Therapies
≥3
|
5 Participants
n=46 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=53 Participants
|
PRIMARY outcome
Timeframe: Date treatment initiated to date off study, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.0. A minimal response is defined as a 5% overall response rate (Partial Response (PR) + Complete Response (CR)
Outcome measures
| Measure |
Pediatric Participants w/Alveolar Soft Part Sarcoma
n=7 Participants
Pediatric participants (\<16 years old) will be treated with 12 mg/m\^2/day once a day for 28 days (28-day cycles).
AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS).
|
Pediatric Participants w/Alveolar Soft Part Sarcoma
Pediatric participants (\<16 years old) will be treated with 12 mg/m\^2/day once a day for 28 days (28-day cycles).
AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS).
|
|---|---|---|
|
Minimal Response Rate in Pediatric Participants With Alveolar Soft Part Sarcoma (ASPS)
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: 2 cycles (e.g., one cycle = 28 days)Population: 45/46 participants were analyzed because one participant was not treated.
Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all no-target lesions and normalization of tumor marker level. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Outcome measures
| Measure |
Pediatric Participants w/Alveolar Soft Part Sarcoma
n=45 Participants
Pediatric participants (\<16 years old) will be treated with 12 mg/m\^2/day once a day for 28 days (28-day cycles).
AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS).
|
Pediatric Participants w/Alveolar Soft Part Sarcoma
Pediatric participants (\<16 years old) will be treated with 12 mg/m\^2/day once a day for 28 days (28-day cycles).
AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS).
|
|---|---|---|
|
Number of Participants With a Response (Partial Response (PR) + Complete Response (CR)) of AZD2171 in Adult Participants With Alveolar Soft Part Sarcoma (ASPS)
Complete Response
|
0 Participants
|
—
|
|
Number of Participants With a Response (Partial Response (PR) + Complete Response (CR)) of AZD2171 in Adult Participants With Alveolar Soft Part Sarcoma (ASPS)
Partial Response
|
13 Participants
|
—
|
PRIMARY outcome
Timeframe: Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete Response is disappearance of all target lesions and normalization of tumor marker level. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive disease is at least a 20% increase in the sum of the LD of target lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Outcome measures
| Measure |
Pediatric Participants w/Alveolar Soft Part Sarcoma
n=7 Participants
Pediatric participants (\<16 years old) will be treated with 12 mg/m\^2/day once a day for 28 days (28-day cycles).
AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS).
|
Pediatric Participants w/Alveolar Soft Part Sarcoma
Pediatric participants (\<16 years old) will be treated with 12 mg/m\^2/day once a day for 28 days (28-day cycles).
AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS).
|
|---|---|---|
|
Number of Participants With a Best Observed Response
Complete Response
|
0 Participants
|
—
|
|
Number of Participants With a Best Observed Response
Partial Response
|
0 Participants
|
—
|
|
Number of Participants With a Best Observed Response
Stable Disease
|
5 Participants
|
—
|
|
Number of Participants With a Best Observed Response
Progressive Disease
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: Date treatment initiated to date off study, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)Population: 45/46 participants were analyzed because one participant did not receive any treatment on the trial.
Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete Response is disappearance of all target lesions and normalization of tumor marker level. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive disease is at least a 20% increase in the sum of the LD of target lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Outcome measures
| Measure |
Pediatric Participants w/Alveolar Soft Part Sarcoma
n=45 Participants
Pediatric participants (\<16 years old) will be treated with 12 mg/m\^2/day once a day for 28 days (28-day cycles).
AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS).
|
Pediatric Participants w/Alveolar Soft Part Sarcoma
Pediatric participants (\<16 years old) will be treated with 12 mg/m\^2/day once a day for 28 days (28-day cycles).
AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS).
|
|---|---|---|
|
Number of Participants With a Best Response
Complete Response
|
0 Participants
|
—
|
|
Number of Participants With a Best Response
Partial Response
|
13 Participants
|
—
|
|
Number of Participants With a Best Response
Stable Disease
|
30 Participants
|
—
|
|
Number of Participants With a Best Response
Progressive Disease
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
Pediatric Participants w/Alveolar Soft Part Sarcoma
n=46 Participants
Pediatric participants (\<16 years old) will be treated with 12 mg/m\^2/day once a day for 28 days (28-day cycles).
AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS).
|
Pediatric Participants w/Alveolar Soft Part Sarcoma
n=7 Participants
Pediatric participants (\<16 years old) will be treated with 12 mg/m\^2/day once a day for 28 days (28-day cycles).
AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS).
|
|---|---|---|
|
Number of Participants With Serious and Non-serious Adverse Events
|
45 Participants
|
7 Participants
|
Adverse Events
Adult Participants w/Alveolar Soft Part Sarcoma
Serious events: 22 serious events
Other events: 45 other events
Deaths: 2 deaths
Pediatric Participants w/Alveolar Soft Part Sarcoma
Serious events: 6 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adult Participants w/Alveolar Soft Part Sarcoma
n=46 participants at risk
Adult participants will be treated with 30 mg by mouth once a day for 28 days (28-day cycles).
AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS).
|
Pediatric Participants w/Alveolar Soft Part Sarcoma
n=7 participants at risk
Pediatric participants (\<16 years old) will be treated with 12 mg/m\^2/day once a day for 28 days (28-day cycles).
AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS).
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Renal and urinary disorders
Acute kidney injury
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Investigations
Alanine aminotransferase increased
|
6.5%
3/46 • Number of events 3 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Investigations
Alkaline phosphatase increased
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Investigations
Aspartate aminotransferase increased
|
4.3%
2/46 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Investigations
Blood bilirubin increased
|
4.3%
2/46 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Investigations
CPK increased
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Psychiatric disorders
Confusion
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Investigations
Creatinine increased
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Metabolism and nutrition disorders
Dehydration
|
6.5%
3/46 • Number of events 3 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Gastrointestinal disorders
Diarrhea
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Nervous system disorders
Dizziness
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Gastrointestinal disorders
Dyspepsia
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.3%
2/46 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Gastrointestinal disorders
Fever
|
0.00%
0/46 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Injury, poisoning and procedural complications
Fracture
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Nervous system disorders
Headache
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Infections and infestations
Hepatitis viral
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Vascular disorders
Hypertension
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
28.6%
2/7 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Vascular disorders
Hypotension
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Investigations
Lipase increased
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Infections and infestations
Lung infection
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Metabolism and nutrition disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/46 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Gastrointestinal disorders
Nausea
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Investigations
Neutrophil count decreased
|
4.3%
2/46 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Cardiac disorders
Palpitations
|
0.00%
0/46 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Eye disorders
Papilledema
|
0.00%
0/46 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Infections and infestations
Paronychia
|
0.00%
0/46 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.2%
1/46 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Reproductive system and breast disorders
Pregnancy, puerperium and perinatal conditions - Other, Pregnancy
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Nervous system disorders
Presyncope
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Renal and urinary disorders
Proteinuria
|
10.9%
5/46 • Number of events 7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, Asthma
|
0.00%
0/46 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Investigations
Serum amylase increased
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Cardiac disorders
Sinus bradycardia
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
General disorders
Sudden death NOS
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/46 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, SCFE
|
0.00%
0/46 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Nervous system disorders
Syncope
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Reproductive system and breast disorders
Testicular disorder
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
6.5%
3/46 • Number of events 3 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Investigations
White blood cell decreased
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
Other adverse events
| Measure |
Adult Participants w/Alveolar Soft Part Sarcoma
n=46 participants at risk
Adult participants will be treated with 30 mg by mouth once a day for 28 days (28-day cycles).
AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS).
|
Pediatric Participants w/Alveolar Soft Part Sarcoma
n=7 participants at risk
Pediatric participants (\<16 years old) will be treated with 12 mg/m\^2/day once a day for 28 days (28-day cycles).
AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS).
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
6.5%
3/46 • Number of events 5 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Gastrointestinal disorders
Abdominal pain
|
65.2%
30/46 • Number of events 66 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
57.1%
4/7 • Number of events 7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Investigations
Activated partial thromboplastin time prolonged
|
4.3%
2/46 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Renal and urinary disorders
Acute kidney injury
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Endocrine disorders
Adrenal insufficiency
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Investigations
Alanine aminotransferase increased
|
73.9%
34/46 • Number of events 130 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
42.9%
3/7 • Number of events 13 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Investigations
Alkaline phosphatase increased
|
34.8%
16/46 • Number of events 43 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
42.9%
3/7 • Number of events 15 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Immune system disorders
Allergic reaction
|
4.3%
2/46 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
15.2%
7/46 • Number of events 8 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
28.6%
2/7 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.9%
5/46 • Number of events 9 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Blood and lymphatic system disorders
Anemia
|
39.1%
18/46 • Number of events 62 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
71.4%
5/7 • Number of events 10 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Metabolism and nutrition disorders
Anorexia
|
37.0%
17/46 • Number of events 22 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
71.4%
5/7 • Number of events 6 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Psychiatric disorders
Anxiety
|
13.0%
6/46 • Number of events 10 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.9%
5/46 • Number of events 5 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Investigations
Aspartate aminotransferase increased
|
73.9%
34/46 • Number of events 126 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
42.9%
3/7 • Number of events 10 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
30.4%
14/46 • Number of events 17 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
57.1%
4/7 • Number of events 5 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/46 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Investigations
Blood bilirubin increased
|
28.3%
13/46 • Number of events 62 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
28.6%
2/7 • Number of events 35 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Eye disorders
Blurred vision
|
10.9%
5/46 • Number of events 8 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.7%
4/46 • Number of events 5 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Reproductive system and breast disorders
Breast pain
|
4.3%
2/46 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Investigations
CPK increased
|
21.7%
10/46 • Number of events 18 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
28.6%
2/7 • Number of events 10 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Gastrointestinal disorders
Cheilitis
|
4.3%
2/46 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/46 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
8.7%
4/46 • Number of events 4 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 4 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
General disorders
Chills
|
6.5%
3/46 • Number of events 7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/46 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Psychiatric disorders
Confusion
|
4.3%
2/46 • Number of events 3 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Gastrointestinal disorders
Constipation
|
28.3%
13/46 • Number of events 33 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
42.9%
3/7 • Number of events 4 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
26.1%
12/46 • Number of events 14 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
42.9%
3/7 • Number of events 3 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Investigations
Creatinine increased
|
15.2%
7/46 • Number of events 19 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
28.6%
2/7 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Metabolism and nutrition disorders
Dehydration
|
13.0%
6/46 • Number of events 10 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
28.6%
2/7 • Number of events 3 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Gastrointestinal disorders
Dental caries
|
4.3%
2/46 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Psychiatric disorders
Depression
|
10.9%
5/46 • Number of events 9 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
28.6%
2/7 • Number of events 4 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Gastrointestinal disorders
Diarrhea
|
95.7%
44/46 • Number of events 183 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
85.7%
6/7 • Number of events 36 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Nervous system disorders
Dizziness
|
34.8%
16/46 • Number of events 26 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Eye disorders
Dry eye
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Gastrointestinal disorders
Dry mouth
|
8.7%
4/46 • Number of events 4 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.7%
4/46 • Number of events 5 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Nervous system disorders
Dysgeusia
|
6.5%
3/46 • Number of events 3 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
28.6%
2/7 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Gastrointestinal disorders
Dyspepsia
|
13.0%
6/46 • Number of events 6 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Gastrointestinal disorders
Dysphagia
|
4.3%
2/46 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.5%
3/46 • Number of events 4 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
28.6%
2/7 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, ear fluid collection
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Ear and labyrinth disorders
Ear pain
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Gastrointestinal disorders
Edema limbs
|
10.9%
5/46 • Number of events 7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Cardiac disorders
Electrocardiogram QT corrected interval prolonged
|
6.5%
3/46 • Number of events 4 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Ear and labyrinth disorders
Endocrine disorders - Other, TSH elevated
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
17.4%
8/46 • Number of events 12 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
42.9%
3/7 • Number of events 10 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Gastrointestinal disorders
Esophageal hemorrhage
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Eye disorders
Extraocular muscle paresis
|
2.2%
1/46 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Eye disorders
Eye disorders - Other, Retinal degeneration
|
0.00%
0/46 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Eye disorders
Eye pain
|
4.3%
2/46 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Eye disorders
Eyelid function disorder
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/46 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
General disorders
Fatigue
|
71.7%
33/46 • Number of events 49 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
85.7%
6/7 • Number of events 17 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
General disorders
Fever
|
10.9%
5/46 • Number of events 6 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
71.4%
5/7 • Number of events 11 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Gastrointestinal disorders
Flatulence
|
8.7%
4/46 • Number of events 4 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
28.6%
2/7 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
General disorders
Flu like symptoms
|
10.9%
5/46 • Number of events 8 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
28.6%
2/7 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Injury, poisoning and procedural complications
Fracture
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
General disorders
Gait disturbance
|
0.00%
0/46 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 3 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Gastroenteritis
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/46 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Nervous system disorders
Headache
|
47.8%
22/46 • Number of events 80 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
85.7%
6/7 • Number of events 15 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.2%
1/46 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Renal and urinary disorders
Hematuria
|
8.7%
4/46 • Number of events 7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Investigations
Hemoglobin increased
|
0.00%
0/46 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Renal and urinary disorders
Hemoglobinuria
|
41.3%
19/46 • Number of events 53 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
8.7%
4/46 • Number of events 4 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Vascular disorders
Hot flashes
|
6.5%
3/46 • Number of events 4 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
47.8%
22/46 • Number of events 46 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
28.6%
2/7 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
13.0%
6/46 • Number of events 9 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
13.0%
6/46 • Number of events 7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
23.9%
11/46 • Number of events 16 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 3 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
28.3%
13/46 • Number of events 15 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Metabolism and nutrition disorders
Hypernatremia
|
6.5%
3/46 • Number of events 4 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
42.9%
3/7 • Number of events 3 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Nervous system disorders
Hypersomnia
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Vascular disorders
Hypertension
|
76.1%
35/46 • Number of events 879 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
42.9%
3/7 • Number of events 21 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Endocrine disorders
Hyperthyroidism
|
8.7%
4/46 • Number of events 7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 3 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
15.2%
7/46 • Number of events 23 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
58.7%
27/46 • Number of events 101 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
21.7%
10/46 • Number of events 19 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
42.9%
3/7 • Number of events 4 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
8.7%
4/46 • Number of events 4 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Metabolism and nutrition disorders
Hypokalemia
|
19.6%
9/46 • Number of events 11 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
58.7%
27/46 • Number of events 81 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
63.0%
29/46 • Number of events 71 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
17.4%
8/46 • Number of events 28 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
28.6%
2/7 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Vascular disorders
Hypotension
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Endocrine disorders
Hypothyroidism
|
71.7%
33/46 • Number of events 70 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
28.6%
2/7 • Number of events 6 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Immune system disorders
Immune system disorders - Other, Total protein decreased
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Infections and infestations
Infections and infestations - Other, Cold sores
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Infections and infestations
Infections and infestations - Other, Infection in armpit
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Infections and infestations
Infections and infestations - Other, Mouth infection
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Infections and infestations
Infections and infestations - Other, Toe nail
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Psychiatric disorders
Insomnia
|
23.9%
11/46 • Number of events 15 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Investigations
Investigations - Other, Bicarbonate, serum-low
|
8.7%
4/46 • Number of events 10 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Reproductive system and breast disorders
Irregular menstruation
|
8.7%
4/46 • Number of events 5 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
4.3%
2/46 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Investigations
Lipase increased
|
2.2%
1/46 • Number of events 4 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Infections and infestations
Lung infection
|
4.3%
2/46 • Number of events 4 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Investigations
Lymphocyte count decreased
|
45.7%
21/46 • Number of events 98 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
42.9%
3/7 • Number of events 20 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
General disorders
Malaise
|
2.2%
1/46 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Reproductive system and breast disorders
Menorrhagia
|
6.5%
3/46 • Number of events 4 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Infections and infestations
Mucosal infection
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Gastrointestinal disorders
Mucositis oral
|
63.0%
29/46 • Number of events 51 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.7%
4/46 • Number of events 6 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
28.6%
2/7 • Number of events 3 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Infections and infestations
Nail infection
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
8.7%
4/46 • Number of events 4 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
19.6%
9/46 • Number of events 18 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Gastrointestinal disorders
Nausea
|
58.7%
27/46 • Number of events 56 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
71.4%
5/7 • Number of events 6 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.5%
3/46 • Number of events 5 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Nervous system disorders
Nervous system disorders - Other, Right side paresthesia
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Investigations
Neutrophil count decreased
|
23.9%
11/46 • Number of events 57 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
42.9%
3/7 • Number of events 54 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain
|
13.0%
6/46 • Number of events 7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
42.9%
3/7 • Number of events 8 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Gastrointestinal disorders
Oral hemorrhage
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Gastrointestinal disorders
Oral pain
|
4.3%
2/46 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Ear and labyrinth disorders
Otitis externa
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Ear and labyrinth disorders
Otitis media
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
General disorders
Pain
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
28.6%
2/7 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
15.2%
7/46 • Number of events 12 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
71.4%
5/7 • Number of events 9 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
54.3%
25/46 • Number of events 35 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 3 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Cardiac disorders
Palpitations
|
8.7%
4/46 • Number of events 4 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Nervous system disorders
Paresthesia
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Infections and infestations
Paronychia
|
0.00%
0/46 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.2%
1/46 • Number of events 20 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pericardial effusion
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Gastrointestinal disorders
Periodontal disease
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
13.0%
6/46 • Number of events 6 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Psychiatric disorders
Personality change
|
0.00%
0/46 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Infections and infestations
Pharyngitis
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.00%
0/46 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Investigations
Platelet count decreased
|
34.8%
16/46 • Number of events 71 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
57.1%
4/7 • Number of events 15 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
6.5%
3/46 • Number of events 3 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/46 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Renal and urinary disorders
Proteinuria
|
73.9%
34/46 • Number of events 157 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
71.4%
5/7 • Number of events 23 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.5%
3/46 • Number of events 3 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
23.9%
11/46 • Number of events 19 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
28.6%
2/7 • Number of events 5 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.5%
3/46 • Number of events 3 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
42.9%
3/7 • Number of events 3 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Gastrointestinal disorders
Rectal pain
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, Dysuria
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, Running nose
|
0.00%
0/46 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Infections and infestations
Rhinitis infective
|
0.00%
0/46 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Eye disorders
Scleral disorder
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Nervous system disorders
Seizure
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Investigations
Serum amylase increased
|
2.2%
1/46 • Number of events 8 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 3 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Cardiac disorders
Sinus bradycardia
|
4.3%
2/46 • Number of events 3 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
28.6%
2/7 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Nervous system disorders
Sinus pain
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Cardiac disorders
Sinus tachycardia
|
10.9%
5/46 • Number of events 5 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
28.6%
2/7 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Infections and infestations
Sinusitis
|
6.5%
3/46 • Number of events 6 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
28.6%
2/7 • Number of events 3 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Acne
|
0.00%
0/46 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Fight laceration
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Perianal irritation
|
0.00%
0/46 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Skin and subcut. Tissue disorder
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Infections and infestations
Skin infection
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Nervous system disorders
Somnolence
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
8.7%
4/46 • Number of events 4 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
57.1%
4/7 • Number of events 6 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Gastrointestinal disorders
Stomach pain
|
4.3%
2/46 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Reproductive system and breast disorders
Testicular disorder
|
2.2%
1/46 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Reproductive system and breast disorders
Testicular pain
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Vascular disorders
Thromboembolic event
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Ear and labyrinth disorders
Tinnitus
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Gastrointestinal disorders
Toothache
|
4.3%
2/46 • Number of events 3 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
28.6%
2/7 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Nervous system disorders
Tremor
|
4.3%
2/46 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
30.4%
14/46 • Number of events 22 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
28.6%
2/7 • Number of events 5 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Infections and infestations
Upper respiratory infection
|
21.7%
10/46 • Number of events 10 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Renal and urinary disorders
Urinary frequency
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Infections and infestations
Urinary tract infection
|
23.9%
11/46 • Number of events 13 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Renal and urinary disorders
Urinary tract pain
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Renal and urinary disorders
Urinary urgency
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Renal and urinary disorders
Urine discoloration
|
2.2%
1/46 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Reproductive system and breast disorders
Uterine hemorrhage
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Infections and infestations
Vaginal infection
|
6.5%
3/46 • Number of events 3 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Reproductive system and breast disorders
Vaginal pain
|
0.00%
0/46 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Vascular disorders
Vascular disorders - Other, Hemoptysis
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
23.9%
11/46 • Number of events 12 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
23/46 • Number of events 67 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
57.1%
4/7 • Number of events 5 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Eye disorders
Watering eyes
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Investigations
Weight gain
|
4.3%
2/46 • Number of events 3 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Investigations
Weight loss
|
54.3%
25/46 • Number of events 78 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
42.9%
3/7 • Number of events 9 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.2%
1/46 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Investigations
White blood cell decreased
|
47.8%
22/46 • Number of events 79 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
42.9%
3/7 • Number of events 40 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/46 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Reproductive system and breast disorders
Gynecomastia
|
0.00%
0/46 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Investigations
Lymphocyte count increased
|
6.5%
3/46 • Number of events 4 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
2.2%
1/46 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
0.00%
0/7 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Investigations
Thyroid stimulating hormone increased
|
0.00%
0/46 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
28.6%
2/7 • Number of events 3 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/46 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 2 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
0.00%
0/46 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.00%
0/46 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Immune system disorders
Immune system disorders - Other, Left inguinal adenopathy
|
0.00%
0/46 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, callouses on both feet
|
0.00%
0/46 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
14.3%
1/7 • Number of events 1 • Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place