Trial Outcomes & Findings for Trabectedin Combined With Durvalumab in Patients With Advanced Pretreated Soft-tissue Sarcomas and Ovarian Carcinomas. (NCT NCT03085225)
NCT ID: NCT03085225
Last Updated: 2025-09-04
Results Overview
A DLT is defined as an AE or laboratory abnormality that fulfills all the criteria below: * Begins on the first 21 days of treatment. * Is considered to be at least possibly related to the study treatment. * Meets one of the criteria below, graded as outlined or according to NCI-CTCAEv4.03 : * Any grade-4 toxicity (except for vomiting without maximal symptomatic/prophylactic treatment and if toxicity is transaminitis, but which have to be resolved at Day 21, i.e. return to Baseline or grade 1). * Grade-3 non-haematological toxicity lasting \> 7days. * Grade-3 hematologic toxicity lasting for \> 7days. * Grade 4 neutropenia with fever. * Grade \> 2 thrombocytopenia with bleeding. Endpoints: * Toxicity graded using the common toxicity criteria from the the NCI-CTCAE v4.03. * Incidence rate of DLT at each dose level during the first 21 days.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
During the first cycle (21 days)
Results posted on
2025-09-04
Participant Flow
40 patients were included of the study from October 19th 2017 to November 6th 2019. Inclusions were carried out in two French centers : Institut Bergonié, Bordeaux and Centre Léon Bérard, Lyon
Participant milestones
| Measure |
Dose Escalation (Trabectedin Dose Level 1,0 mg/m²)
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
Dose Escalation (Trabectedin Dose Level 1,2 mg/m²)
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
Expansion Cohort - Soft-tissue Sarcoma (STS)
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
Expansion Cohort - Ovarian Carcinomas (OV)
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
16
|
15
|
|
Overall Study
COMPLETED
|
3
|
6
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Dose Escalation (Trabectedin Dose Level 1,0 mg/m²)
n=3 Participants
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
Dose Escalation (Trabectedin Dose Level 1,2 mg/m²)
n=6 Participants
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
Expansion Cohort - Soft-tissue Sarcoma (STS)
n=16 Participants
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
Expansion Cohort - Ovarian Carcinomas (OV)
n=15 Participants
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
8 Participants
n=16 Participants
|
9 Participants
n=15 Participants
|
25 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
8 Participants
n=16 Participants
|
6 Participants
n=15 Participants
|
15 Participants
n=40 Participants
|
|
Age, Continuous
|
52.6 years
STANDARD_DEVIATION 7.7 • n=3 Participants
|
58.1 years
STANDARD_DEVIATION 7.6 • n=6 Participants
|
53.5 years
STANDARD_DEVIATION 18.1 • n=16 Participants
|
64.2 years
STANDARD_DEVIATION 6.6 • n=15 Participants
|
58.1 years
STANDARD_DEVIATION 13.3 • n=40 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
10 Participants
n=16 Participants
|
15 Participants
n=15 Participants
|
32 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
6 Participants
n=16 Participants
|
0 Participants
n=15 Participants
|
8 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
ECOG
ECOG=0
|
2 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
10 Participants
n=16 Participants
|
10 Participants
n=15 Participants
|
27 Participants
n=40 Participants
|
|
ECOG
ECOG=1
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
6 Participants
n=16 Participants
|
5 Participants
n=15 Participants
|
13 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: During the first cycle (21 days)Population: The following patients will not be included in the population assessable for safety (primary analysis) and thus will be replaced: * Patients who received ≤ 75% RDI (Relative Dose Intensity) for trabectedin OR ≤ 75% RDI for durvalumab over cycle 1, due to drug-related AE not considered as DLT. * Patients who goes off treatment over cycle 1 for reasons unrelated to toxicity (DLT or any other AE), e.g. progression, lost to follow-up, will be replaced
A DLT is defined as an AE or laboratory abnormality that fulfills all the criteria below: * Begins on the first 21 days of treatment. * Is considered to be at least possibly related to the study treatment. * Meets one of the criteria below, graded as outlined or according to NCI-CTCAEv4.03 : * Any grade-4 toxicity (except for vomiting without maximal symptomatic/prophylactic treatment and if toxicity is transaminitis, but which have to be resolved at Day 21, i.e. return to Baseline or grade 1). * Grade-3 non-haematological toxicity lasting \> 7days. * Grade-3 hematologic toxicity lasting for \> 7days. * Grade 4 neutropenia with fever. * Grade \> 2 thrombocytopenia with bleeding. Endpoints: * Toxicity graded using the common toxicity criteria from the the NCI-CTCAE v4.03. * Incidence rate of DLT at each dose level during the first 21 days.
Outcome measures
| Measure |
Dose Escalation (Trabectedin Dose Level 1,0 mg/m²)
n=3 Participants
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
Dose Escalation (Trabectedin Dose Level 1,2 mg/m²)
n=6 Participants
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
|---|---|---|
|
Dose Escalation Part: Establish the Recommended Phase II Dose (RP2D), the Maximum Tolerated Dose (MTD) Evaluated on the First Cycle (D1 to D21), the Safety Profile, and the Dose Limiting Toxicities (DLT) of Trabectedin Given in Combination With Durvalumab
|
0 Number of DLTs
|
1 Number of DLTs
|
PRIMARY 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 5.1 monthsPopulation: Population assessable for efficacy: All patients eligible and for whom the following conditions are statisfied: * Received at least one complete or two incomplete treatment cycles, * At least one disease measurement recorded not less than six weeks after treatment onset.
Following RECIST v1.1 recommendations: * Objective response rate (ORR) is defined as the proportion of patients with complete or partial response (CR, PR) as per RECIST v1.1 criteria. * Objective response under treatment is recorded from study treatment initiation until the end of treatment and determined once all the data for the patient is known. * Claimed responses will have to be confirmed at least 4 weeks later to ensure responses identified are not the result of measurement errors. * Disease status under treatment, whatever the response observed, will be centrally reviewed for all patients, by an independent expert radiologist. Reviewed data will be used for the efficacy analysis.
Outcome measures
| Measure |
Dose Escalation (Trabectedin Dose Level 1,0 mg/m²)
n=14 Participants
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
Dose Escalation (Trabectedin Dose Level 1,2 mg/m²)
n=14 Participants
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
|---|---|---|
|
Expansion Cohorts : Evaluate Preliminary Signs of the Antitumor Activity of Trabectedin Given in Combination With Durvalumab in Terms of Objective Response Under Treatment.
|
1 Participants
|
3 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 5.1 monthsBest overall response is defined as the best response recorded from the start of the study treatment until the end of treatment taking into account any requirement for confirmation as per RECIST v1.1 criteria: Following RECIST v1.1 recommendations: * The best overall response is determined once all the data for the patient is known. * Claimed responses will have to be confirmed at least 4 weeks later to ensure responses identified are not the result of measurement errors.
Outcome measures
| Measure |
Dose Escalation (Trabectedin Dose Level 1,0 mg/m²)
n=3 Participants
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
Dose Escalation (Trabectedin Dose Level 1,2 mg/m²)
n=6 Participants
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
|---|---|---|
|
Dose Escalation Part: Preliminary Signs of Antitumor Activity, Best Overall Response (BOR)
Complete response
|
0 Participants
|
1 Participants
|
|
Dose Escalation Part: Preliminary Signs of Antitumor Activity, Best Overall Response (BOR)
Stable disease
|
2 Participants
|
4 Participants
|
|
Dose Escalation Part: Preliminary Signs of Antitumor Activity, Best Overall Response (BOR)
Progressive disease
|
1 Participants
|
1 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, an average of 5.1 months and ORR at 6-monthObjective response rate (ORR) is defined as the proportion of patients with complete response or partial response according to RECIST v1.1 criteria. ORR under treatment and 6-month ORR will be reported ORR under treatment is recorded from study treatment initiation until the end of treatment. Following RECIST v1.1 recommendations: * ORR under treatment is determined once all the data for the patient is known. * Claimed responses will have to be confirmed at least 4 weeks later to ensure responses identified are not the result of measurement errors.
Outcome measures
| Measure |
Dose Escalation (Trabectedin Dose Level 1,0 mg/m²)
n=3 Participants
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
Dose Escalation (Trabectedin Dose Level 1,2 mg/m²)
n=6 Participants
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
|---|---|---|
|
Dose Escalation Part : Objective Response Rate (ORR)
6-month Objective response
|
0 Participants
|
1 Participants
|
|
Dose Escalation Part : Objective Response Rate (ORR)
Objective response under treatment
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6-month progression-free Rate (PFR) as per RECIST v1.1Progression-free rate (PFR) is defined as the proportion of patients with complete response, partial response or stable disease more than 24 weeks as defined as per RECIST v1.1 criteria. 6-month PFR will be reported. Following RECIST v1.1 recommendations, claimed responses will have to be confirmed at least 4 weeks later to ensure responses identified are not the result of measurement errors.
Outcome measures
| Measure |
Dose Escalation (Trabectedin Dose Level 1,0 mg/m²)
n=3 Participants
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
Dose Escalation (Trabectedin Dose Level 1,2 mg/m²)
n=6 Participants
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
|---|---|---|
|
Dose Escalation Part : Progression-free Rate (PFR) at 6-month
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 1-year progression-free survival (PFS) rate as per RECIST v1.1Population: Given the small sample size in each arm (3 patients in the arm "Dose Escalation (Trabectedin Dose Level 1,0 mg/m²)" and 6 patients in the arm "Dose Escalation (Trabectedin Dose Level 1,2 mg/m²)", we had pre-specified to combine these 2 arms, regardless of dose administered, for the calculation of "Dose Escalation Part : 1-year Progression-free Survival (PFS).
Progression-free survival (PFS) is defined as the time from study treatment initiation to the first occurrence of disease progression or death (of any cause), whichever occurs first. 1-year PFS rate will be reported.
Outcome measures
| Measure |
Dose Escalation (Trabectedin Dose Level 1,0 mg/m²)
n=9 Participants
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
Dose Escalation (Trabectedin Dose Level 1,2 mg/m²)
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
|---|---|---|
|
Dose Escalation Part : 1-year Progression-free Survival (PFS)
|
22.2 percentage of participants
Interval 3.4 to 51.3
|
—
|
SECONDARY outcome
Timeframe: 1-year Overall Survival (OS) as per RECIST v1.1Population: Given the small sample size in each arm (3 patients in the arm "Dose Escalation (Trabectedin Dose Level 1,0 mg/m²)" and 6 patients in the arm "Dose Escalation (Trabectedin Dose Level 1,2 mg/m²)", we had pre-specified to combine these 2 arms, regardless of dose administered, for the calculation of "Dose Escalation Part : 1-year Overall Survival (OS)".
Overall Survival (OS) is defined as the time from study treatment initiation to death (of any cause). 1-year OS rate will be reported.
Outcome measures
| Measure |
Dose Escalation (Trabectedin Dose Level 1,0 mg/m²)
n=9 Participants
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
Dose Escalation (Trabectedin Dose Level 1,2 mg/m²)
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
|---|---|---|
|
Dose Escalation Part : 1-year Overall Survival (OS)
|
88.9 percentage of participants
Interval 43.3 to 98.4
|
—
|
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 5.1 monthsBest overall response is defined as the best response recorded from the start of the study treatment until the end of treatment taking into account any requirement for confirmation as per RECIST v1.1 criteria: Following RECIST v1.1 recommendations: The best overall response is determined once all the data for the patient is known. Claimed responses will have to be confirmed at least 4 weeks later to ensure responses identified are not the result of measurement errors.
Outcome measures
| Measure |
Dose Escalation (Trabectedin Dose Level 1,0 mg/m²)
n=14 Participants
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
Dose Escalation (Trabectedin Dose Level 1,2 mg/m²)
n=14 Participants
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
|---|---|---|
|
Expansion Cohorts: Preliminary Signs of Antitumor Activity, Best Overall Response (BOR)
Partial response
|
1 Participants
|
3 Participants
|
|
Expansion Cohorts: Preliminary Signs of Antitumor Activity, Best Overall Response (BOR)
Stable disease
|
8 Participants
|
5 Participants
|
|
Expansion Cohorts: Preliminary Signs of Antitumor Activity, Best Overall Response (BOR)
Progressive disease
|
4 Participants
|
5 Participants
|
|
Expansion Cohorts: Preliminary Signs of Antitumor Activity, Best Overall Response (BOR)
Not evaluable
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6-month Objective response rate (ORR) as per RECIST v1.1Objective response rate (ORR) is defined as the proportion of patients with complete response or partial response according to RECIST v1.1 criteria. 6-month ORR will be reported. Following RECIST v1.1 recommendations: Claimed responses will have to be confirmed at least 4 weeks later to ensure responses identified are not the result of measurement errors.
Outcome measures
| Measure |
Dose Escalation (Trabectedin Dose Level 1,0 mg/m²)
n=14 Participants
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
Dose Escalation (Trabectedin Dose Level 1,2 mg/m²)
n=14 Participants
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
|---|---|---|
|
Expansion Cohorts : 6-month Objective Response Rate (ORR)
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 6-month progression-free rate (PFR) as per RECIST v1.1Progression-free rate (PFR) is defined as the proportion of patients with complete response, partial response or stable disease more than 24 weeks as defined as per RECIST v1.1 criteria. 6-month PFR will be reported. . Following RECIST v1.1 recommendations, claimed responses will have to be confirmed at least 4 weeks later to ensure responses identified are not the result of measurement errors.
Outcome measures
| Measure |
Dose Escalation (Trabectedin Dose Level 1,0 mg/m²)
n=14 Participants
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
Dose Escalation (Trabectedin Dose Level 1,2 mg/m²)
n=14 Participants
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
|---|---|---|
|
Expansion Cohorts: 6-month Progression-free Rate (PFR)
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 1-year Progression-free survival (PFS) as per RECIST v1.1Progression-free survival (PFS) is defined as the time from study treatment initiation to the first occurrence of disease progression or death (of any cause), whichever occurs first. 1-year PFS rate will be reported.
Outcome measures
| Measure |
Dose Escalation (Trabectedin Dose Level 1,0 mg/m²)
n=14 Participants
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
Dose Escalation (Trabectedin Dose Level 1,2 mg/m²)
n=14 Participants
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
|---|---|---|
|
Expansion Cohorts: 1-year Progression-free Survival (PFS)
|
14.3 percentage of participants
Interval 2.3 to 36.6
|
7.1 percentage of participants
Interval 0.5 to 27.5
|
SECONDARY outcome
Timeframe: 1-year Overall Survival (OS) as per RECIST v1.1Overall Survival (OS) is defined as the time from study treatment initiation to death (of any cause). 1-year OS rate will be reported.
Outcome measures
| Measure |
Dose Escalation (Trabectedin Dose Level 1,0 mg/m²)
n=14 Participants
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
Dose Escalation (Trabectedin Dose Level 1,2 mg/m²)
n=14 Participants
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
|---|---|---|
|
Expansion Cohort : 1-year Overall Survival (OS)
|
56.3 percentage of participants
Interval 27.2 to 77.6
|
57.1 percentage of participants
Interval 28.4 to 78.0
|
Adverse Events
Dose Escalation (Trabectedin Dose Level 1,0 mg/m²)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Dose Escalation (Trabectedin Dose Level 1,2 mg/m²)
Serious events: 3 serious events
Other events: 6 other events
Deaths: 3 deaths
Expansion Cohort - Soft-tissue Sarcoma (STS)
Serious events: 9 serious events
Other events: 16 other events
Deaths: 8 deaths
Expansion Cohort - Ovarian Carcinomas (OV)
Serious events: 7 serious events
Other events: 14 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Dose Escalation (Trabectedin Dose Level 1,0 mg/m²)
n=3 participants at risk
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
Dose Escalation (Trabectedin Dose Level 1,2 mg/m²)
n=6 participants at risk
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
Expansion Cohort - Soft-tissue Sarcoma (STS)
n=16 participants at risk
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
Expansion Cohort - Ovarian Carcinomas (OV)
n=14 participants at risk
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Device related infection
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
2/6 • Number of events 2 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Left ventricular systolic dysfunction
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
12.5%
2/16 • Number of events 2 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
DEGRADATION OF GENERAL STATUS
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Thromboembolic event
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
12.5%
2/16 • Number of events 2 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Febrile neutropenia
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
12.5%
2/16 • Number of events 3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Acute kidney injury
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
PROGRESSIVE DISEASE
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
SUBOCCLUSIVE SYNDROME
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 (Trabectedin Dose Level 1,0 mg/m²)
n=3 participants at risk
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
Dose Escalation (Trabectedin Dose Level 1,2 mg/m²)
n=6 participants at risk
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
Expansion Cohort - Soft-tissue Sarcoma (STS)
n=16 participants at risk
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
Expansion Cohort - Ovarian Carcinomas (OV)
n=14 participants at risk
Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
2/6 • Number of events 3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
12.5%
2/16 • Number of events 2 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Acute kidney injury
|
33.3%
1/3 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
66.7%
2/3 • Number of events 2 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
83.3%
5/6 • Number of events 7 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
37.5%
6/16 • Number of events 9 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
64.3%
9/14 • Number of events 12 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
4/6 • Number of events 5 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
18.8%
3/16 • Number of events 3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 7 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
33.3%
1/3 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
3/6 • Number of events 5 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
31.2%
5/16 • Number of events 8 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 7 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
25.0%
4/16 • Number of events 8 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
71.4%
10/14 • Number of events 13 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
3/6 • Number of events 3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
25.0%
4/16 • Number of events 4 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
66.7%
2/3 • Number of events 3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
83.3%
5/6 • Number of events 8 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
43.8%
7/16 • Number of events 10 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
78.6%
11/14 • Number of events 13 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
33.3%
1/3 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
12.5%
2/16 • Number of events 2 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Breast pain
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 2 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Chills
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
33.3%
1/3 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
100.0%
3/3 • Number of events 5 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
4/6 • Number of events 8 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
18.8%
3/16 • Number of events 4 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
64.3%
9/14 • Number of events 13 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
1/3 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
2/6 • Number of events 2 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
37.5%
6/16 • Number of events 6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
66.7%
2/3 • Number of events 3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
25.0%
4/16 • Number of events 7 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Dry skin
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 2 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
12.5%
2/16 • Number of events 2 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 4 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
33.3%
1/3 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
2/6 • Number of events 2 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
37.5%
6/16 • Number of events 10 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
57.1%
8/14 • Number of events 10 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Dysphagia
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
33.3%
1/3 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
3/6 • Number of events 3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
37.5%
6/16 • Number of events 10 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 14 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
CHALAZION
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
1/3 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
100.0%
3/3 • Number of events 4 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
6/6 • Number of events 8 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
81.2%
13/16 • Number of events 17 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
14/14 • Number of events 19 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
66.7%
2/3 • Number of events 2 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
2/6 • Number of events 3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
18.8%
3/16 • Number of events 5 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Flank pain
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
1/3 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 2 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
GLAIRY STOOLS
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
OCCLUSIVE SYNDROME
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
STOOL DISCOLORATION
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
SUB OCCLUSIVE SYNDROMA
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Aphtosis
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 2 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
12.5%
2/16 • Number of events 2 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
66.7%
2/3 • Number of events 2 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
4/6 • Number of events 4 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
31.2%
5/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Endocrine disorders
Hyperthyroidism
|
33.3%
1/3 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Hypotension
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Endocrine disorders
Hypothyroidism
|
33.3%
1/3 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Allergic rhinitis
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Anal pain
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
12.5%
2/16 • Number of events 2 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Atrial fibrillation
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Bloating
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Bone marrow hypocellular
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
18.8%
3/16 • Number of events 3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 2 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
TACHYCARDIA
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Creatinine increased
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Depression
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
12.5%
2/16 • Number of events 2 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
12.5%
2/16 • Number of events 2 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 limbs
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
31.2%
5/16 • Number of events 6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Enterocolitis infectious
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Erectile dysfunction
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
12.5%
2/16 • Number of events 2 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Febrile neutropenia
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Fecal incontinence
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Flatulence
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
COLD
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Generalized muscle weakness
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Headache
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 2 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
COVID 19 SYMPTOMS
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Infusion related reaction
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Injection site reaction
|
33.3%
1/3 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 INCREASE
|
33.3%
1/3 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
TSH INCREASE
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Lipase increased
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Localized edema
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 2 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Lung infection
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
66.7%
2/3 • Number of events 3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
3/6 • Number of events 4 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
12.5%
2/16 • Number of events 2 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Malaise
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
33.3%
1/3 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
12.5%
2/16 • Number of events 2 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Mucosal infection
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
STIFFNESS
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 2 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
CRAMPS
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
HAND CRAMP
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
MUSCLE CRAMPS
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
33.3%
1/3 • Number of events 4 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
2/6 • Number of events 3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
43.8%
7/16 • Number of events 10 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 14 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 discoloration
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Nasal congestion
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
100.0%
3/3 • Number of events 6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
83.3%
5/6 • Number of events 8 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
81.2%
13/16 • Number of events 19 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
71.4%
10/14 • Number of events 20 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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)
HEPATIC KYST
|
33.3%
1/3 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
TINGLING HANDS
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
LEFT LATERAL EPICONDYLITIS
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
33.3%
1/3 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
66.7%
2/3 • Number of events 3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
4/6 • Number of events 7 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
8/16 • Number of events 18 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
57.1%
8/14 • Number of events 20 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
18.8%
3/16 • Number of events 4 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Pain
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
25.0%
4/16 • Number of events 5 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Pain in extremity
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 2 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Pelvic pain
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Peripheral motor neuropathy
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Pharyngitis
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Pharyngolaryngeal pain
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Photosensitivity
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
2/6 • Number of events 2 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
12.5%
2/16 • Number of events 2 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Prostatic pain
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Pruritus
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
TEMPO-SPATIAL DISORIENTATION
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Rectal hemorrhage
|
33.3%
1/3 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
NOSE PAIN AND SCABS
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
BRONCHITIS
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
HEMOPTYSIS
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
12.5%
2/16 • Number of events 2 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Rhinitis infective
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
12.5%
2/16 • Number of events 2 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
33.3%
1/3 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
ECZEMA
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
ECZEMA ERUPTION
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
FACE'S CUTANEOUS RASH
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 hyperpigmentation
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Somnolence
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
33.3%
1/3 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Testicular pain
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Upper respiratory infection
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Urinary tract infection
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 frequency
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 incontinence
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 tract pain
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 2 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 discharge
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 hemorrhage
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 inflammation
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
|
33.3%
1/3 • Number of events 2 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
3/6 • Number of events 6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
18.8%
3/16 • Number of events 5 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
71.4%
10/14 • Number of events 14 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
16.7%
1/6 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
Vasovagal reaction
|
33.3%
1/3 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
White blood cell decreased
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported. Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
|
6.2%
1/16 • Number of events 1 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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
PSYCHOMOTOR RETARDATION
|
0.00%
0/3 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/6 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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%
0/16 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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 • Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration. All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related 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