Trial Outcomes & Findings for Metronomic Chemotherapy in Patients With Advanced Solid Tumor With Bone Metastasis and Advanced Pretreated Osteosarcoma (NCT NCT02517918)
NCT ID: NCT02517918
Last Updated: 2025-06-08
Results Overview
A DLT is defined as an adverse event (AE) or laboratory abnormality that fulfills the criteria below: * Is considered to be at least possibly related to the study treatment * Occurs during the first cycle of treatment * Is unrelated to disease, disease progression, inter-current illness, or concomitant medications * Meets one of the criteria below, graded as outlined or according to NCI CTCAEv4.3: * Grade 4 non-haematological toxicity (not laboratory) * Grade 3 non-haematological toxicity \> 3 days (not laboratory) (except for asthenia, 1rst episode of nausea/vomiting without maximal symptomatic/prophylactic treatment) * Grade ≥ 3 non-hematologic laboratory value if medical intervention is required to treat the patient, or the abnormality leads to hospitalization, or the abnormality persists for \> 1 week * Grade ≥ 3 hematologic toxicity \> 3 days (except for lymphopenia) * Grade 4 lymphopenia * Confirmed febrile neutropenia
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
During the first cycle (28 days)
Results posted on
2025-06-08
Participant Flow
First patient enrolled: February 16th, 2015 and last patient enrolled: March 11th, 2021
Participant milestones
| Measure |
Dose Escalation Part With Sirolimus (Si) Dose 4 mg
Prospective open-labeled phase I trial. The dose escalation design to identify the maximum tolerated dose will be the traditional 3+3 design.
Sirolimus (SI) dose 4 mg when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) Sirolimus will be administered per os once daily, continuously. One cycle consits of 28 days.
Number of subjects : 6. Cyclophosphamide will be administered per os bi-daily (50 mg x 2), and given on a week on/week off schedule.
Methotrexate will be administered per os bi-daily (2.5 mg x 2), and given on day 1 and 4 every week.
Zoledronic acid will be administered at home by intravenous infusion (4 mg) on Day 2 of each cycle, every 4 weeks.
|
Dose Escalation Part With Sirolimus (SI) Dose 6 mg
Prospective open-labeled phase I trial. The dose escalation design to identify the maximum tolerated dose will be the traditional 3+3 design.
Sirolimus (SI) dose 6 mg when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) Sirolimus will be administered per os once daily, continuously. One cycle consits of 28 days.
Number of subjects : 3. Cyclophosphamide will be administered per os bi-daily (50 mg x 2), and given on a week on/week off schedule.
Methotrexate will be administered per os bi-daily (2.5 mg x 2), and given on day 1 and 4 every week.
Zoledronic acid will be administered at home by intravenous infusion (4 mg) on Day 2 of each cycle, every 4 weeks.
|
Expansion Cohort With Dose Sirolimus (SI) 4 mg
Prospective open-labeled phase I trial. The expansion cohort is designed to enable to detect antitumor activity observed with sirolimus (SI) combined with cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA).
Sirolimus (SI) dose 4 mg when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) Sirolimus will be administered per os once daily, continuously. One cycle consits of 28 days.
Number of subjects : 14. Cyclophosphamide will be administered per os bi-daily (50 mg x 2), and given on a week on/week off schedule.
Methotrexate will be administered per os bi-daily (2.5 mg x 2), and given on day 1 and 4 every week.
Zoledronic acid will be administered at home by intravenous infusion (4 mg) on Day 2 of each cycle, every 4 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
14
|
|
Overall Study
COMPLETED
|
6
|
3
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Metronomic Chemotherapy in Patients With Advanced Solid Tumor With Bone Metastasis and Advanced Pretreated Osteosarcoma
Baseline characteristics by cohort
| Measure |
Dose Escalation Part With Sirolimus (Si) Dose 4 mg
n=6 Participants
Prospective open-labeled phase I trial. The dose escalation design to identify the maximum tolerated dose will be the traditional 3+3 design.
Sirolimus (SI) dose 4 mg when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) Sirolimus will be administered per os once daily, continuously. One cycle consits of 28 days.
Number of subjects : 6. Cyclophosphamide will be administered per os bi-daily (50 mg x 2), and given on a week on/week off schedule.
Methotrexate will be administered per os bi-daily (2.5 mg x 2), and given on day 1 and 4 every week.
Zoledronic acid will be administered at home by intravenous infusion (4 mg) on Day 2 of each cycle, every 4 weeks.
|
Dose Escalation Part With Sirolimus (SI) Dose 6 mg
n=3 Participants
Prospective open-labeled phase I trial. The dose escalation design to identify the maximum tolerated dose will be the traditional 3+3 design.
Sirolimus (SI) dose 6 mg when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) Sirolimus will be administered per os once daily, continuously. One cycle consits of 28 days.
Number of subjects : 3. Cyclophosphamide will be administered per os bi-daily (50 mg x 2), and given on a week on/week off schedule.
Methotrexate will be administered per os bi-daily (2.5 mg x 2), and given on day 1 and 4 every week.
Zoledronic acid will be administered at home by intravenous infusion (4 mg) on Day 2 of each cycle, every 4 weeks.
|
Expansion Cohort With Dose Sirolimus (SI) 4 mg
n=14 Participants
Prospective open-labeled phase I trial. The expansion cohort is designed to enable to detect antitumor activity observed with sirolimus (SI) combined with cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA).
Sirolimus (SI) dose 4 mg when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) Sirolimus will be administered per os once daily, continuously. One cycle consits of 28 days.
Number of subjects : 14. Cyclophosphamide will be administered per os bi-daily (50 mg x 2), and given on a week on/week off schedule.
Methotrexate will be administered per os bi-daily (2.5 mg x 2), and given on day 1 and 4 every week.
Zoledronic acid will be administered at home by intravenous infusion (4 mg) on Day 2 of each cycle, every 4 weeks.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52.5 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
65.4 years
STANDARD_DEVIATION 12 • n=7 Participants
|
36.3 years
STANDARD_DEVIATION 21.4 • n=5 Participants
|
44.3 years
STANDARD_DEVIATION 21.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Region of Enrollment
France
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
14 participants
n=5 Participants
|
23 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: During the first cycle (28 days)Population: Population assessable : Patients who received at least one dose of one of the trial's products and have received the complete C1 cycle (28 days: D1 to D28) or have exhibited a DLT during C1.
A DLT is defined as an adverse event (AE) or laboratory abnormality that fulfills the criteria below: * Is considered to be at least possibly related to the study treatment * Occurs during the first cycle of treatment * Is unrelated to disease, disease progression, inter-current illness, or concomitant medications * Meets one of the criteria below, graded as outlined or according to NCI CTCAEv4.3: * Grade 4 non-haematological toxicity (not laboratory) * Grade 3 non-haematological toxicity \> 3 days (not laboratory) (except for asthenia, 1rst episode of nausea/vomiting without maximal symptomatic/prophylactic treatment) * Grade ≥ 3 non-hematologic laboratory value if medical intervention is required to treat the patient, or the abnormality leads to hospitalization, or the abnormality persists for \> 1 week * Grade ≥ 3 hematologic toxicity \> 3 days (except for lymphopenia) * Grade 4 lymphopenia * Confirmed febrile neutropenia
Outcome measures
| Measure |
Dose Escalation Part With Sirolimus (Si) Dose 4 mg
n=6 Participants
Prospective open-labeled phase I trial. The dose escalation design to identify the maximum tolerated dose will be the traditional 3+3 design.
Sirolimus (SI) dose 4 mg when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) Sirolimus will be administered per os once daily, continuously. One cycle consits of 28 days.
Number of subjects : 6. Cyclophosphamide will be administered per os bi-daily (50 mg x 2), and given on a week on/week off schedule.
Methotrexate will be administered per os bi-daily (2.5 mg x 2), and given on day 1 and 4 every week.
Zoledronic acid will be administered at home by intravenous infusion (4 mg) on Day 2 of each cycle, every 4 weeks.
|
Dose Escalation Part With Sirolimus (SI) Dose 6 mg
n=3 Participants
Prospective open-labeled phase I trial. The dose escalation design to identify the maximum tolerated dose will be the traditional 3+3 design.
Sirolimus (SI) dose 6 mg when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) Sirolimus will be administered per os once daily, continuously. One cycle consits of 28 days.
Number of subjects : 3. Cyclophosphamide will be administered per os bi-daily (50 mg x 2), and given on a week on/week off schedule.
Methotrexate will be administered per os bi-daily (2.5 mg x 2), and given on day 1 and 4 every week.
Zoledronic acid will be administered at home by intravenous infusion (4 mg) on Day 2 of each cycle, every 4 weeks.
|
|---|---|---|
|
Dose Escalation Part: Number of Dose-Limiting Toxicities (DLTs) at Each Dose Level on Cycle 1
|
0 Number of DLTs
|
2 Number of DLTs
|
PRIMARY outcome
Timeframe: 6-month non-progression rate as per RECIST v1.1Population: Population assessable : Patients eligible and who received at least one complete or two incomplete treatment cycles and least one disease measurement recorded not less than eight weeks after treatment onset.
6-month non-progression rate defined as the rate of complete or partial response or stable disease at 6 months using RECIST v1.1 : * Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. * Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions and also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). * Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD * Unevaluable : patients stopped the treatment before tumor assessment.
Outcome measures
| Measure |
Dose Escalation Part With Sirolimus (Si) Dose 4 mg
n=14 Participants
Prospective open-labeled phase I trial. The dose escalation design to identify the maximum tolerated dose will be the traditional 3+3 design.
Sirolimus (SI) dose 4 mg when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) Sirolimus will be administered per os once daily, continuously. One cycle consits of 28 days.
Number of subjects : 6. Cyclophosphamide will be administered per os bi-daily (50 mg x 2), and given on a week on/week off schedule.
Methotrexate will be administered per os bi-daily (2.5 mg x 2), and given on day 1 and 4 every week.
Zoledronic acid will be administered at home by intravenous infusion (4 mg) on Day 2 of each cycle, every 4 weeks.
|
Dose Escalation Part With Sirolimus (SI) Dose 6 mg
Prospective open-labeled phase I trial. The dose escalation design to identify the maximum tolerated dose will be the traditional 3+3 design.
Sirolimus (SI) dose 6 mg when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) Sirolimus will be administered per os once daily, continuously. One cycle consits of 28 days.
Number of subjects : 3. Cyclophosphamide will be administered per os bi-daily (50 mg x 2), and given on a week on/week off schedule.
Methotrexate will be administered per os bi-daily (2.5 mg x 2), and given on day 1 and 4 every week.
Zoledronic acid will be administered at home by intravenous infusion (4 mg) on Day 2 of each cycle, every 4 weeks.
|
|---|---|---|
|
Expansion Cohort : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, in Terms of 6-month Non-progression Rate
Complete response
|
0 participants
|
—
|
|
Expansion Cohort : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, in Terms of 6-month Non-progression Rate
Partial response confirmed
|
1 participants
|
—
|
|
Expansion Cohort : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, in Terms of 6-month Non-progression Rate
Stable disease
|
1 participants
|
—
|
|
Expansion Cohort : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, in Terms of 6-month Non-progression Rate
Progression
|
10 participants
|
—
|
|
Expansion Cohort : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, in Terms of 6-month Non-progression Rate
Unevaluable according to RECIST v1.1
|
2 participants
|
—
|
SECONDARY outcome
Timeframe: Tumor assessment were repeated every 8 weeks (±7 days, i.e Week 8, 16, 24, etc.) from the start of treatment and at least 4 weeks after the first CR or PR, even if there are treatment delays, an average of 4 months.Population: Population assessable : Patients who received at least one dose of one of the trial's products and have received the complete C1 cycle (28 days: D1 to D28) or have exhibited a DLT during C1.
The best objective response (BOR) is the best response recorded for each patient from the start of the study treatment until the end of treatment for progressive disease, death, patient or investigator decision. BOR is determined by investigator review of tumor assessments using RECIST v1.1 : * Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm * Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters * Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions and also demonstrate an absolute increase of at least 5 mm * Stable Disease (SD) Tumor assessment were repeated every 8 weeks (±7 days, i.e Week 8, 16, 24, etc.) from start of treatment and at least 4 weeks after the first CR or PR, even if there are treatment delays, average of 4 months
Outcome measures
| Measure |
Dose Escalation Part With Sirolimus (Si) Dose 4 mg
n=6 Participants
Prospective open-labeled phase I trial. The dose escalation design to identify the maximum tolerated dose will be the traditional 3+3 design.
Sirolimus (SI) dose 4 mg when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) Sirolimus will be administered per os once daily, continuously. One cycle consits of 28 days.
Number of subjects : 6. Cyclophosphamide will be administered per os bi-daily (50 mg x 2), and given on a week on/week off schedule.
Methotrexate will be administered per os bi-daily (2.5 mg x 2), and given on day 1 and 4 every week.
Zoledronic acid will be administered at home by intravenous infusion (4 mg) on Day 2 of each cycle, every 4 weeks.
|
Dose Escalation Part With Sirolimus (SI) Dose 6 mg
n=3 Participants
Prospective open-labeled phase I trial. The dose escalation design to identify the maximum tolerated dose will be the traditional 3+3 design.
Sirolimus (SI) dose 6 mg when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) Sirolimus will be administered per os once daily, continuously. One cycle consits of 28 days.
Number of subjects : 3. Cyclophosphamide will be administered per os bi-daily (50 mg x 2), and given on a week on/week off schedule.
Methotrexate will be administered per os bi-daily (2.5 mg x 2), and given on day 1 and 4 every week.
Zoledronic acid will be administered at home by intravenous infusion (4 mg) on Day 2 of each cycle, every 4 weeks.
|
|---|---|---|
|
Dose Escalation Part : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, Best Objective Response Rate (ORR) as Per RECIST v1.1
Completed response
|
0 participants
|
0 participants
|
|
Dose Escalation Part : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, Best Objective Response Rate (ORR) as Per RECIST v1.1
Partial response
|
0 participants
|
0 participants
|
|
Dose Escalation Part : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, Best Objective Response Rate (ORR) as Per RECIST v1.1
Stable disease
|
3 participants
|
1 participants
|
|
Dose Escalation Part : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, Best Objective Response Rate (ORR) as Per RECIST v1.1
Progression
|
2 participants
|
1 participants
|
|
Dose Escalation Part : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, Best Objective Response Rate (ORR) as Per RECIST v1.1
Inevaluable for response
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 1-year Progression-free survival (PFS) as per RECIST v1.1Population: Population assessable : Patients who received at least one dose of one of the trial's products and have received the complete C1 cycle (28 days: D1 to D28) or have exhibited a DLT during C1.
1-year Progression-free survival (PFS) is defined as the time from study treatment initiation to the first occurrence of disease progression, as determined by investigator review of tumor assessments using RECIST v1.1, or death from any cause during the study (i.e., within 30 days after the last dose of study treatment). Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Outcome measures
| Measure |
Dose Escalation Part With Sirolimus (Si) Dose 4 mg
n=6 Participants
Prospective open-labeled phase I trial. The dose escalation design to identify the maximum tolerated dose will be the traditional 3+3 design.
Sirolimus (SI) dose 4 mg when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) Sirolimus will be administered per os once daily, continuously. One cycle consits of 28 days.
Number of subjects : 6. Cyclophosphamide will be administered per os bi-daily (50 mg x 2), and given on a week on/week off schedule.
Methotrexate will be administered per os bi-daily (2.5 mg x 2), and given on day 1 and 4 every week.
Zoledronic acid will be administered at home by intravenous infusion (4 mg) on Day 2 of each cycle, every 4 weeks.
|
Dose Escalation Part With Sirolimus (SI) Dose 6 mg
n=3 Participants
Prospective open-labeled phase I trial. The dose escalation design to identify the maximum tolerated dose will be the traditional 3+3 design.
Sirolimus (SI) dose 6 mg when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) Sirolimus will be administered per os once daily, continuously. One cycle consits of 28 days.
Number of subjects : 3. Cyclophosphamide will be administered per os bi-daily (50 mg x 2), and given on a week on/week off schedule.
Methotrexate will be administered per os bi-daily (2.5 mg x 2), and given on day 1 and 4 every week.
Zoledronic acid will be administered at home by intravenous infusion (4 mg) on Day 2 of each cycle, every 4 weeks.
|
|---|---|---|
|
Dose Escalation Part : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, 1-year Progression-free Survival (PFS)
|
6 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 1-year Overall Survival (OS) as per RECIST v1.1Population: Population assessable : Patients who received at least one dose of one of the trial's products and have received the complete C1 cycle (28 days: D1 to D28) or have exhibited a DLT during C1.
1-year Overall Survival (OS) is defined as the time from first infusion to death (of any cause)
Outcome measures
| Measure |
Dose Escalation Part With Sirolimus (Si) Dose 4 mg
n=6 Participants
Prospective open-labeled phase I trial. The dose escalation design to identify the maximum tolerated dose will be the traditional 3+3 design.
Sirolimus (SI) dose 4 mg when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) Sirolimus will be administered per os once daily, continuously. One cycle consits of 28 days.
Number of subjects : 6. Cyclophosphamide will be administered per os bi-daily (50 mg x 2), and given on a week on/week off schedule.
Methotrexate will be administered per os bi-daily (2.5 mg x 2), and given on day 1 and 4 every week.
Zoledronic acid will be administered at home by intravenous infusion (4 mg) on Day 2 of each cycle, every 4 weeks.
|
Dose Escalation Part With Sirolimus (SI) Dose 6 mg
n=3 Participants
Prospective open-labeled phase I trial. The dose escalation design to identify the maximum tolerated dose will be the traditional 3+3 design.
Sirolimus (SI) dose 6 mg when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) Sirolimus will be administered per os once daily, continuously. One cycle consits of 28 days.
Number of subjects : 3. Cyclophosphamide will be administered per os bi-daily (50 mg x 2), and given on a week on/week off schedule.
Methotrexate will be administered per os bi-daily (2.5 mg x 2), and given on day 1 and 4 every week.
Zoledronic acid will be administered at home by intravenous infusion (4 mg) on Day 2 of each cycle, every 4 weeks.
|
|---|---|---|
|
Dose Escalation Part : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, 1-year Overall Survival (OS)
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Tumor assessment were repeated every 8 weeks (±7 days, i.e Week 8, 16, 24, etc.) from the start of treatment and at least 4 weeks after the first CR or PR, even if there are treatment delays, an average of 4 months.Population: Population assessable : Patients eligible and who received at least one complete or two incomplete treatment cycles and least one disease measurement recorded not less than eight weeks after treatment onset.
The best objective response (BOR) is the best response recorded for each patient from the start of the study treatment until the end of treatment for progressive disease, death, patient or investigator decision. BOR is determined by investigator review of tumor assessments using RECIST v1.1 : * Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm * Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters * Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions and also demonstrate an absolute increase of at least 5 mm * Stable Disease (SD) Tumor assessment were repeated every 8 weeks (±7 days, i.e Week 8, 16, 24, etc.) from start of treatment and at least 4 weeks after the first CR or PR, even if there are treatment delays, an average of 4 months
Outcome measures
| Measure |
Dose Escalation Part With Sirolimus (Si) Dose 4 mg
n=14 Participants
Prospective open-labeled phase I trial. The dose escalation design to identify the maximum tolerated dose will be the traditional 3+3 design.
Sirolimus (SI) dose 4 mg when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) Sirolimus will be administered per os once daily, continuously. One cycle consits of 28 days.
Number of subjects : 6. Cyclophosphamide will be administered per os bi-daily (50 mg x 2), and given on a week on/week off schedule.
Methotrexate will be administered per os bi-daily (2.5 mg x 2), and given on day 1 and 4 every week.
Zoledronic acid will be administered at home by intravenous infusion (4 mg) on Day 2 of each cycle, every 4 weeks.
|
Dose Escalation Part With Sirolimus (SI) Dose 6 mg
Prospective open-labeled phase I trial. The dose escalation design to identify the maximum tolerated dose will be the traditional 3+3 design.
Sirolimus (SI) dose 6 mg when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) Sirolimus will be administered per os once daily, continuously. One cycle consits of 28 days.
Number of subjects : 3. Cyclophosphamide will be administered per os bi-daily (50 mg x 2), and given on a week on/week off schedule.
Methotrexate will be administered per os bi-daily (2.5 mg x 2), and given on day 1 and 4 every week.
Zoledronic acid will be administered at home by intravenous infusion (4 mg) on Day 2 of each cycle, every 4 weeks.
|
|---|---|---|
|
Expansion Cohort : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, Best Objective Response Rate (ORR) as Per RECIST v1.1
Complete response
|
0 participants
|
—
|
|
Expansion Cohort : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, Best Objective Response Rate (ORR) as Per RECIST v1.1
Confirmed Partial response
|
1 participants
|
—
|
|
Expansion Cohort : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, Best Objective Response Rate (ORR) as Per RECIST v1.1
Stable disease
|
3 participants
|
—
|
|
Expansion Cohort : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, Best Objective Response Rate (ORR) as Per RECIST v1.1
Progression
|
8 participants
|
—
|
|
Expansion Cohort : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, Best Objective Response Rate (ORR) as Per RECIST v1.1
Inevaluable for response
|
2 participants
|
—
|
SECONDARY outcome
Timeframe: 1-year Progression-free survival (PFS) as per RECIST v1.1Population: Population assessable : Patients eligible and who received at least one complete or two incomplete treatment cycles and least one disease measurement recorded not less than eight weeks after treatment onset.
1-year Progression-free survival (PFS) is defined as the time from study treatment initiation to the first occurrence of disease progression, as determined by investigator review of tumor assessments using RECIST v1.1, or death from any cause during the study (i.e., within 30 days after the last dose of study treatment). Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Outcome measures
| Measure |
Dose Escalation Part With Sirolimus (Si) Dose 4 mg
n=14 Participants
Prospective open-labeled phase I trial. The dose escalation design to identify the maximum tolerated dose will be the traditional 3+3 design.
Sirolimus (SI) dose 4 mg when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) Sirolimus will be administered per os once daily, continuously. One cycle consits of 28 days.
Number of subjects : 6. Cyclophosphamide will be administered per os bi-daily (50 mg x 2), and given on a week on/week off schedule.
Methotrexate will be administered per os bi-daily (2.5 mg x 2), and given on day 1 and 4 every week.
Zoledronic acid will be administered at home by intravenous infusion (4 mg) on Day 2 of each cycle, every 4 weeks.
|
Dose Escalation Part With Sirolimus (SI) Dose 6 mg
Prospective open-labeled phase I trial. The dose escalation design to identify the maximum tolerated dose will be the traditional 3+3 design.
Sirolimus (SI) dose 6 mg when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) Sirolimus will be administered per os once daily, continuously. One cycle consits of 28 days.
Number of subjects : 3. Cyclophosphamide will be administered per os bi-daily (50 mg x 2), and given on a week on/week off schedule.
Methotrexate will be administered per os bi-daily (2.5 mg x 2), and given on day 1 and 4 every week.
Zoledronic acid will be administered at home by intravenous infusion (4 mg) on Day 2 of each cycle, every 4 weeks.
|
|---|---|---|
|
Expansion Cohort : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, 1-year Progression-free Survival (PFS) as Per RECIST v1.1
|
1.8 months
Interval 1.4 to 3.6
|
—
|
SECONDARY outcome
Timeframe: 1-year Overall Survival (OS) as per RECIST v1.1Population: Population assessable : Patients eligible and who received at least one complete or two incomplete treatment cycles and least one disease measurement recorded not less than eight weeks after treatment onset.
1-year Overall Survival (OS) is defined as the time from first infusion to death (of any cause)
Outcome measures
| Measure |
Dose Escalation Part With Sirolimus (Si) Dose 4 mg
n=14 Participants
Prospective open-labeled phase I trial. The dose escalation design to identify the maximum tolerated dose will be the traditional 3+3 design.
Sirolimus (SI) dose 4 mg when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) Sirolimus will be administered per os once daily, continuously. One cycle consits of 28 days.
Number of subjects : 6. Cyclophosphamide will be administered per os bi-daily (50 mg x 2), and given on a week on/week off schedule.
Methotrexate will be administered per os bi-daily (2.5 mg x 2), and given on day 1 and 4 every week.
Zoledronic acid will be administered at home by intravenous infusion (4 mg) on Day 2 of each cycle, every 4 weeks.
|
Dose Escalation Part With Sirolimus (SI) Dose 6 mg
Prospective open-labeled phase I trial. The dose escalation design to identify the maximum tolerated dose will be the traditional 3+3 design.
Sirolimus (SI) dose 6 mg when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) Sirolimus will be administered per os once daily, continuously. One cycle consits of 28 days.
Number of subjects : 3. Cyclophosphamide will be administered per os bi-daily (50 mg x 2), and given on a week on/week off schedule.
Methotrexate will be administered per os bi-daily (2.5 mg x 2), and given on day 1 and 4 every week.
Zoledronic acid will be administered at home by intravenous infusion (4 mg) on Day 2 of each cycle, every 4 weeks.
|
|---|---|---|
|
Expansion Cohort : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, 1-year Overall Survival (OS) as Per RECIST v1.1
|
7 Participants
|
—
|
Adverse Events
Dose Escalation Part With Sirolimus (Si) Dose 4 mg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Dose Escalation Part With Sirolimus (SI) Dose 6 mg
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Expansion Cohort With Dose Sirolimus (SI) 4 mg
Serious events: 9 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Escalation Part With Sirolimus (Si) Dose 4 mg
n=6 participants at risk
Prospective open-labeled phase I trial. The dose escalation design to identify the maximum tolerated dose will be the traditional 3+3 design.
Sirolimus (SI) dose 4 mg when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) Sirolimus will be administered per os once daily, continuously. One cycle consits of 28 days.
Number of subjects : 6. Cyclophosphamide will be administered per os bi-daily (50 mg x 2), and given on a week on/week off schedule.
Methotrexate will be administered per os bi-daily (2.5 mg x 2), and given on day 1 and 4 every week.
Zoledronic acid will be administered at home by intravenous infusion (4 mg) on Day 2 of each cycle, every 4 weeks.
|
Dose Escalation Part With Sirolimus (SI) Dose 6 mg
n=3 participants at risk
Prospective open-labeled phase I trial. The dose escalation design to identify the maximum tolerated dose will be the traditional 3+3 design.
Sirolimus (SI) dose 6 mg when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) Sirolimus will be administered per os once daily, continuously. One cycle consits of 28 days.
Number of subjects : 3. Cyclophosphamide will be administered per os bi-daily (50 mg x 2), and given on a week on/week off schedule.
Methotrexate will be administered per os bi-daily (2.5 mg x 2), and given on day 1 and 4 every week.
Zoledronic acid will be administered at home by intravenous infusion (4 mg) on Day 2 of each cycle, every 4 weeks.
|
Expansion Cohort With Dose Sirolimus (SI) 4 mg
n=14 participants at risk
Prospective open-labeled phase I trial. The expansion cohort is designed to enable to detect antitumor activity observed with sirolimus (SI) combined with cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA).
Sirolimus (SI) dose 4 mg when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) Sirolimus will be administered per os once daily, continuously. One cycle consits of 28 days.
Number of subjects : 14. Cyclophosphamide will be administered per os bi-daily (50 mg x 2), and given on a week on/week off schedule.
Methotrexate will be administered per os bi-daily (2.5 mg x 2), and given on day 1 and 4 every week.
Zoledronic acid will be administered at home by intravenous infusion (4 mg) on Day 2 of each cycle, every 4 weeks.
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
16.7%
1/6 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
14.3%
2/14 • Number of events 2 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
General disorders
Musculoskeletal chest pain
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
33.3%
1/3 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/14 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
33.3%
1/3 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/14 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Gastrointestinal disorders
Ascites
|
16.7%
1/6 • Number of events 7 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/14 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
General disorders
General physical health deterioration
|
16.7%
1/6 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Investigations
Gamma-glutamyltransferase increased
|
16.7%
1/6 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/14 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Investigations
Lymphopenia
|
33.3%
2/6 • Number of events 2 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
14.3%
2/14 • Number of events 2 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
33.3%
1/3 • Number of events 2 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
21.4%
3/14 • Number of events 5 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
General disorders
Fever
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Vascular disorders
Pulmonary embolism
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
14.3%
2/14 • Number of events 2 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
Other adverse events
| Measure |
Dose Escalation Part With Sirolimus (Si) Dose 4 mg
n=6 participants at risk
Prospective open-labeled phase I trial. The dose escalation design to identify the maximum tolerated dose will be the traditional 3+3 design.
Sirolimus (SI) dose 4 mg when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) Sirolimus will be administered per os once daily, continuously. One cycle consits of 28 days.
Number of subjects : 6. Cyclophosphamide will be administered per os bi-daily (50 mg x 2), and given on a week on/week off schedule.
Methotrexate will be administered per os bi-daily (2.5 mg x 2), and given on day 1 and 4 every week.
Zoledronic acid will be administered at home by intravenous infusion (4 mg) on Day 2 of each cycle, every 4 weeks.
|
Dose Escalation Part With Sirolimus (SI) Dose 6 mg
n=3 participants at risk
Prospective open-labeled phase I trial. The dose escalation design to identify the maximum tolerated dose will be the traditional 3+3 design.
Sirolimus (SI) dose 6 mg when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) Sirolimus will be administered per os once daily, continuously. One cycle consits of 28 days.
Number of subjects : 3. Cyclophosphamide will be administered per os bi-daily (50 mg x 2), and given on a week on/week off schedule.
Methotrexate will be administered per os bi-daily (2.5 mg x 2), and given on day 1 and 4 every week.
Zoledronic acid will be administered at home by intravenous infusion (4 mg) on Day 2 of each cycle, every 4 weeks.
|
Expansion Cohort With Dose Sirolimus (SI) 4 mg
n=14 participants at risk
Prospective open-labeled phase I trial. The expansion cohort is designed to enable to detect antitumor activity observed with sirolimus (SI) combined with cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA).
Sirolimus (SI) dose 4 mg when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) Sirolimus will be administered per os once daily, continuously. One cycle consits of 28 days.
Number of subjects : 14. Cyclophosphamide will be administered per os bi-daily (50 mg x 2), and given on a week on/week off schedule.
Methotrexate will be administered per os bi-daily (2.5 mg x 2), and given on day 1 and 4 every week.
Zoledronic acid will be administered at home by intravenous infusion (4 mg) on Day 2 of each cycle, every 4 weeks.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
1/6 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
66.7%
2/3 • Number of events 2 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
28.6%
4/14 • Number of events 6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Eye disorders
Glaucoma
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
14.3%
2/14 • Number of events 2 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
33.3%
1/3 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/14 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6 • Number of events 2 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
35.7%
5/14 • Number of events 5 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
1/6 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/14 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
33.3%
1/3 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/14 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
33.3%
2/6 • Number of events 2 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/14 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Gastrointestinal disorders
Hemorrhoids
|
16.7%
1/6 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Gastrointestinal disorders
Mucositis oral
|
50.0%
3/6 • Number of events 5 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
66.7%
2/3 • Number of events 2 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
42.9%
6/14 • Number of events 8 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • Number of events 2 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
33.3%
1/3 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
35.7%
5/14 • Number of events 5 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
21.4%
3/14 • Number of events 4 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
General disorders
Edema face
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
General disorders
Fatigue
|
50.0%
3/6 • Number of events 3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
100.0%
3/3 • Number of events 3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
42.9%
6/14 • Number of events 6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
General disorders
Fever
|
16.7%
1/6 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
28.6%
4/14 • Number of events 4 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
General disorders
Flu like symptoms
|
33.3%
2/6 • Number of events 2 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/14 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
General disorders
Non-cardiac chest pain
|
16.7%
1/6 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
66.7%
2/3 • Number of events 2 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Infections and infestations
Gum infection
|
16.7%
1/6 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/14 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Infections and infestations
Nail infection
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Infections and infestations
Skin infection
|
16.7%
1/6 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/14 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
2/6 • Number of events 2 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
33.3%
1/3 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
35.7%
5/14 • Number of events 5 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Investigations
Alkaline phosphatase increased
|
16.7%
1/6 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
33.3%
1/3 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
21.4%
3/14 • Number of events 3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
3/6 • Number of events 3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
66.7%
2/3 • Number of events 2 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
28.6%
4/14 • Number of events 4 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Investigations
Blood bilirubin increased
|
16.7%
1/6 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/14 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Investigations
CPK increased
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Investigations
Cholesterol high
|
16.7%
1/6 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/14 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Investigations
GGT increased
|
16.7%
1/6 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
33.3%
1/3 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
14.3%
2/14 • Number of events 2 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Investigations
Lymphocyte count decreased
|
33.3%
2/6 • Number of events 2 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
33.3%
1/3 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
42.9%
6/14 • Number of events 6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
100.0%
3/3 • Number of events 3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
14.3%
2/14 • Number of events 2 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Investigations
Platelet count decreased
|
33.3%
2/6 • Number of events 2 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
100.0%
3/3 • Number of events 3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
50.0%
7/14 • Number of events 8 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Investigations
Weight loss
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
33.3%
1/3 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/14 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
2/6 • Number of events 2 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
66.7%
2/3 • Number of events 2 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.7%
1/6 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/14 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
33.3%
1/3 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
14.3%
2/14 • Number of events 2 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
14.3%
2/14 • Number of events 2 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
16.7%
1/6 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
14.3%
2/14 • Number of events 2 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
16.7%
1/6 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
14.3%
2/14 • Number of events 2 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/14 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
16.7%
1/6 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
14.3%
2/14 • Number of events 2 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
14.3%
2/14 • Number of events 2 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Nervous system disorders
Dysesthesia
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
66.7%
2/3 • Number of events 2 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
14.3%
2/14 • Number of events 2 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Nervous system disorders
Paresthesia
|
16.7%
1/6 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
14.3%
2/14 • Number of events 2 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • Number of events 3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
21.4%
3/14 • Number of events 3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
21.4%
3/14 • Number of events 3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
14.3%
2/14 • Number of events 2 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
33.3%
1/3 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/14 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
33.3%
1/3 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/14 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
16.7%
1/6 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/14 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
1/6 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/14 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
16.7%
1/6 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/14 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
General disorders
WORSENING OF GENERAL STATUS
|
16.7%
1/6 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/14 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
General disorders
INFLAMMATORY SYNDROM
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
14.3%
2/14 • Number of events 2 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
General disorders
HOT FLUSHES
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
General disorders
POLYDYPSIA
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
General disorders
ALTERATION OF GENERAL STATUS
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Investigations
LDH INCREASED
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Investigations
CRP INCREASED
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Metabolism and nutrition disorders
IRON DEFICIENCY
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SUBCUTANEOUS NODULE
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
14.3%
2/14 • Number of events 2 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Renal and urinary disorders
DYSURIA
|
16.7%
1/6 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/14 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Renal and urinary disorders
NOCTURIA
|
16.7%
1/6 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/14 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Renal and urinary disorders
URINARY DISORDERS
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
33.3%
1/3 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/14 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Renal and urinary disorders
POLYURIA
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Reproductive system and breast disorders
VAGINAL ULCERATION
|
16.7%
1/6 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/14 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Skin and subcutaneous tissue disorders
ESCHAR OF THE SACRUM
|
0.00%
0/6 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
0.00%
0/3 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
7.1%
1/14 • Number of events 1 • Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Safety population: all patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place